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Maurizio Fava - One of the best experts on this subject based on the ideXlab platform.
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effect of adjunctive pimavanserin on suicidal ideation in patients with major depression analysis of the clarity study
Journal of Affective Disorders, 2020Co-Authors: Richard C Shelton, Marlene P Freeman, George I Papakostas, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Maurizio Fava, Manish K Jha, Keith Liu, Srdjan StankovicAbstract:Abstract Background Up to 15% of patients with major depressive disorder (MDD) attempt suicide and up to 2% complete suicide. This was a post-hoc analysis aimed to evaluate the risk of suicide ideation and behavior associated with adjunctive pimavanserin treatment in adults with MDD. Methods CLARITY was a randomized, double-blind, placebo-controlled study in patients with MDD and an inadequate response to a selective serotonin Reuptake Inhibitor (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). For this post-hoc analysis, the primary endpoint was mean change from baseline for HAMD item 3 (suicide). The incidence of suicidal ideation or behavior was also assessed from the Columbia-Suicide Severity Rating Scale (C-SSRS) and reports of adverse events. Results During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431). At any post-baseline assessment, suicidal ideation on the C-SSRS was reported in 28 (18.1%) of patients with placebo and 9 (17.3%) with pimavanserin during Stage 1 and in 7 (20.7%) with placebo and 4 (13.8%) with pimavanserin during Stage 2. No events of suicidal behavior were observed with either placebo or pimavanserin. Limitations : The post hoc nature, exclusion of patients with any history of suicide from the primary study, and the small number of patients who demonstrated evidence of suicidal ideation. Conclusions Adjunctive pimavanserin was not associated with an increase in suicidal ideation in patients with MDD. Further study is needed to verify these results.
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180 improvement of sexual function observed during treatment of major depressive disorder with adjunctive pimavanserin
Cns Spectrums, 2020Co-Authors: Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Troy Whitworth, Michael E Thase, Maurizio Fava, Srdjan StankovicAbstract:STUDY OBJECTIVES: Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY trial recently demonstrated the efficacy of adjunctive pimavanserin (PIM) for MDD when added to ongoing selective serotonin or Serotonin-Norepinephrine Reuptake Inhibitor (SSRI/SNRI) treatment. No new safety observations were reported in this study. This post-hoc analysis examines the potential impact of PIM treatment on sexual function. METHOD: Study methodology has been presented previously (APA 2019). Adult male and female patients with moderate-to-severe MDD were randomized to PIM 34 mg/day (n=51) or placebo (PBO, n=152) added to ongoing SSRI/SNRI treatment. Massachusetts General Hospital-Sexual Functioning Inventory (MGH-SFI) and Hamilton Depression Rating Scale, 17-item version (HAMD-17) item 14 (sexual interest) scores were examined by analysis of covariance. RESULTS: Adjunctive PIM resulted in significantly greater 5-week reduction (improvement) relative to SSRI/SNRI treatment plus placebo on mean MGH-SFI scores (difference -0.634, SE 0.167; P<0.001; effect size [ES], Cohen's d 0.614). Similarly, PIM resulted in greater improvement compared with placebo on individual MGH-SFI items that applied to both males and females: Interest in Sex (P=0.006; ES=0.483), Ability to Get Sexually Aroused/Excited (P=0.001; ES=0.560), Ability to Achieve Orgasm (P<0.001; ES=0.609), Overall Sexual Satisfaction (P=0.003; ES=0.524). HAMD-17 item 14 scores were also significantly more reduced (improved) with PIM (P<0.001; ES=0.574). CONCLUSIONS: These results underscore the potential of adjunctive PIM for improving sexual function in patients with MDD and inadequate response to SSRIs/SNRIs. Potential benefits should be confirmed in further studies. FUNDING ACKNOWLEDGEMENTS: ACADIA Pharmaceuticals Inc.
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180 improvement of sexual function observed during treatment of major depressive disorder with adjunctive pimavanserin
Cns Spectrums, 2020Co-Authors: Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Maurizio Fava, Manish K Jha, Keith Liu, Troy WhitworthAbstract:STUDY OBJECTIVES Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY trial recently demonstrated the efficacy of adjunctive pimavanserin (PIM) for MDD when added to ongoing selective serotonin or Serotonin-Norepinephrine Reuptake Inhibitor (SSRI/SNRI) treatment. No new safety observations were reported in this study. This post-hoc analysis examines the potential impact of PIM treatment on sexual function. METHOD Study methodology has been presented previously (APA 2019). Adult male and female patients with moderate-to-severe MDD were randomized to PIM 34 mg/day (n=51) or placebo (PBO, n=152) added to ongoing SSRI/SNRI treatment. Massachusetts General Hospital-Sexual Functioning Inventory (MGH-SFI) and Hamilton Depression Rating Scale, 17-item version (HAMD-17) item 14 (sexual interest) scores were examined by analysis of covariance. RESULTS Adjunctive PIM resulted in significantly greater 5-week reduction (improvement) relative to SSRI/SNRI treatment plus placebo on mean MGH-SFI scores (difference -0.634, SE 0.167; P<0.001; effect size [ES], Cohen's d 0.614). Similarly, PIM resulted in greater improvement compared with placebo on individual MGH-SFI items that applied to both males and females: Interest in Sex (P=0.006; ES=0.483), Ability to Get Sexually Aroused/Excited (P=0.001; ES=0.560), Ability to Achieve Orgasm (P<0.001; ES=0.609), Overall Sexual Satisfaction (P=0.003; ES=0.524). HAMD-17 item 14 scores were also significantly more reduced (improved) with PIM (P<0.001; ES=0.574). CONCLUSIONS These results underscore the potential of adjunctive PIM for improving sexual function in patients with MDD and inadequate response to SSRIs/SNRIs. Potential benefits should be confirmed in further studies. FUNDING ACKNOWLEDGEMENTS ACADIA Pharmaceuticals Inc.
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a phase 2 randomized double blind placebo controlled study of adjunctive pimavanserin in patients with major depressive disorder and an inadequate response to therapy clarity
The Journal of Clinical Psychiatry, 2019Co-Authors: Maurizio Fava, Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Srdjan StankovicAbstract:OBJECTIVE: Pimavanserin is a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist. This phase 2 study examined the efficacy and safety of pimavanserin as adjunctive therapy in patients with major depressive disorder (MDD). METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study in patients with DSM-5-defined MDD and an inadequate response to a selective serotonin Reuptake Inhibitor (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). Using a 2-stage sequential parallel-comparison design, patients were initially randomized in a 3:1 ratio to placebo or pimavanserin added to ongoing SSRI or SNRI therapy; at 5 weeks, placebo nonresponders were re-randomized to placebo or pimavanserin for an additional 5 weeks. Key endpoints were change from baseline to the end of each stage in 17-item Hamilton Depression Rating Scale (HDRS-17) total score and Sheehan Disability Scale (SDS) score. RESULTS: Between December 2016 and October 2018, 207 patients were randomized. For the prespecified pooled Sequential Parallel Comparison Design analyses of Stages 1 and 2, the least squares (LS) mean (SE) difference for the HDRS-17 total score was -1.7 (0.85) (P = .039) and for the SDS score was -0.8 (0.29) (P = .004). At week 5 of Stage 1, LS mean (SE) difference for pimavanserin versus placebo was significant for changes on the HDRS-17 (-4.0 [1.09], P = .0003) and SDS (-1.2 [0.40], P = .0036) with effect sizes of 0.626 and 0.498, respectively. Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week. The most common adverse events with pimavanserin were dry mouth, nausea, and headache. CONCLUSIONS: Pimavanserin demonstrated robust efficacy in patients with MDD and an inadequate response to an SSRI or SNRI. Tolerability was consistent with previous experience. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03018340.
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incident user cohort study of risk for gastrointestinal bleed and stroke in individuals with major depressive disorder treated with antidepressants
BMJ Open, 2012Co-Authors: Victor M Castro, Maurizio Fava, Patience Gallagher, Caitlin C Clements, Shawn N Murphy, Vivian S Gainer, Jeffrey B Weilburg, Susanne Churchill, Isaac S Kohane, Dan V IosifescuAbstract:Objective To examine the association between exposure to newer antidepressants and risk of gastrointestinal (GI) and other bleeding complications among individuals with major depressive disorder (MDD). Design This study uses an incident user cohort design to compare associations between incidence of vascular/bleeding events and the relative affinity (low, moderate or high) of the antidepressant for the serotonin transporter during an exposure risk period for each patient. Setting New England healthcare system electronic medical record database. Participants 36 389 individuals with a diagnosis of MDD and monotherapy with a selective serotonin Reuptake Inhibitor, serotonin–norepinephrine Reuptake Inhibitor or other new-generation antidepressant were identified from among 3.1 million patients in a New England healthcare system. Primary and secondary outcome measures Rates of bleeding or other vascular complications, including acute liver failure, acute renal failure, asthma, breast cancer and hip fractures. Results 601 GI bleeds were observed in the 21 462 subjects in the high-affinity group versus 333 among the 14 927 subjects in the lower affinity group (adjusted RR: 1.17, 95% CI 1.02 to 1.34). Similarly, 776 strokes were observed in the high-affinity group versus 434 in the lower affinity treatment group (adjusted RR: 1.18, 95% CI 1.06 to 1.32). No significant association with risk for a priori negative control outcomes, including acute liver failure, acute renal failure, asthma, breast cancer and hip fractures, was identified. Conclusions Use of antidepressants with high affinity for the serotonin transporter may confer modestly elevated risk for GI and other bleeding complications. While multiple methodologic limitations must be considered, these results suggest that antidepressants with lower serotonin receptor affinity may be preferred in patients at greater risk for such complications.
Michael E Thase - One of the best experts on this subject based on the ideXlab platform.
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effect of adjunctive pimavanserin on suicidal ideation in patients with major depression analysis of the clarity study
Journal of Affective Disorders, 2020Co-Authors: Richard C Shelton, Marlene P Freeman, George I Papakostas, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Maurizio Fava, Manish K Jha, Keith Liu, Srdjan StankovicAbstract:Abstract Background Up to 15% of patients with major depressive disorder (MDD) attempt suicide and up to 2% complete suicide. This was a post-hoc analysis aimed to evaluate the risk of suicide ideation and behavior associated with adjunctive pimavanserin treatment in adults with MDD. Methods CLARITY was a randomized, double-blind, placebo-controlled study in patients with MDD and an inadequate response to a selective serotonin Reuptake Inhibitor (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). For this post-hoc analysis, the primary endpoint was mean change from baseline for HAMD item 3 (suicide). The incidence of suicidal ideation or behavior was also assessed from the Columbia-Suicide Severity Rating Scale (C-SSRS) and reports of adverse events. Results During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431). At any post-baseline assessment, suicidal ideation on the C-SSRS was reported in 28 (18.1%) of patients with placebo and 9 (17.3%) with pimavanserin during Stage 1 and in 7 (20.7%) with placebo and 4 (13.8%) with pimavanserin during Stage 2. No events of suicidal behavior were observed with either placebo or pimavanserin. Limitations : The post hoc nature, exclusion of patients with any history of suicide from the primary study, and the small number of patients who demonstrated evidence of suicidal ideation. Conclusions Adjunctive pimavanserin was not associated with an increase in suicidal ideation in patients with MDD. Further study is needed to verify these results.
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180 improvement of sexual function observed during treatment of major depressive disorder with adjunctive pimavanserin
Cns Spectrums, 2020Co-Authors: Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Troy Whitworth, Michael E Thase, Maurizio Fava, Srdjan StankovicAbstract:STUDY OBJECTIVES: Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY trial recently demonstrated the efficacy of adjunctive pimavanserin (PIM) for MDD when added to ongoing selective serotonin or Serotonin-Norepinephrine Reuptake Inhibitor (SSRI/SNRI) treatment. No new safety observations were reported in this study. This post-hoc analysis examines the potential impact of PIM treatment on sexual function. METHOD: Study methodology has been presented previously (APA 2019). Adult male and female patients with moderate-to-severe MDD were randomized to PIM 34 mg/day (n=51) or placebo (PBO, n=152) added to ongoing SSRI/SNRI treatment. Massachusetts General Hospital-Sexual Functioning Inventory (MGH-SFI) and Hamilton Depression Rating Scale, 17-item version (HAMD-17) item 14 (sexual interest) scores were examined by analysis of covariance. RESULTS: Adjunctive PIM resulted in significantly greater 5-week reduction (improvement) relative to SSRI/SNRI treatment plus placebo on mean MGH-SFI scores (difference -0.634, SE 0.167; P<0.001; effect size [ES], Cohen's d 0.614). Similarly, PIM resulted in greater improvement compared with placebo on individual MGH-SFI items that applied to both males and females: Interest in Sex (P=0.006; ES=0.483), Ability to Get Sexually Aroused/Excited (P=0.001; ES=0.560), Ability to Achieve Orgasm (P<0.001; ES=0.609), Overall Sexual Satisfaction (P=0.003; ES=0.524). HAMD-17 item 14 scores were also significantly more reduced (improved) with PIM (P<0.001; ES=0.574). CONCLUSIONS: These results underscore the potential of adjunctive PIM for improving sexual function in patients with MDD and inadequate response to SSRIs/SNRIs. Potential benefits should be confirmed in further studies. FUNDING ACKNOWLEDGEMENTS: ACADIA Pharmaceuticals Inc.
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180 improvement of sexual function observed during treatment of major depressive disorder with adjunctive pimavanserin
Cns Spectrums, 2020Co-Authors: Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Maurizio Fava, Manish K Jha, Keith Liu, Troy WhitworthAbstract:STUDY OBJECTIVES Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY trial recently demonstrated the efficacy of adjunctive pimavanserin (PIM) for MDD when added to ongoing selective serotonin or Serotonin-Norepinephrine Reuptake Inhibitor (SSRI/SNRI) treatment. No new safety observations were reported in this study. This post-hoc analysis examines the potential impact of PIM treatment on sexual function. METHOD Study methodology has been presented previously (APA 2019). Adult male and female patients with moderate-to-severe MDD were randomized to PIM 34 mg/day (n=51) or placebo (PBO, n=152) added to ongoing SSRI/SNRI treatment. Massachusetts General Hospital-Sexual Functioning Inventory (MGH-SFI) and Hamilton Depression Rating Scale, 17-item version (HAMD-17) item 14 (sexual interest) scores were examined by analysis of covariance. RESULTS Adjunctive PIM resulted in significantly greater 5-week reduction (improvement) relative to SSRI/SNRI treatment plus placebo on mean MGH-SFI scores (difference -0.634, SE 0.167; P<0.001; effect size [ES], Cohen's d 0.614). Similarly, PIM resulted in greater improvement compared with placebo on individual MGH-SFI items that applied to both males and females: Interest in Sex (P=0.006; ES=0.483), Ability to Get Sexually Aroused/Excited (P=0.001; ES=0.560), Ability to Achieve Orgasm (P<0.001; ES=0.609), Overall Sexual Satisfaction (P=0.003; ES=0.524). HAMD-17 item 14 scores were also significantly more reduced (improved) with PIM (P<0.001; ES=0.574). CONCLUSIONS These results underscore the potential of adjunctive PIM for improving sexual function in patients with MDD and inadequate response to SSRIs/SNRIs. Potential benefits should be confirmed in further studies. FUNDING ACKNOWLEDGEMENTS ACADIA Pharmaceuticals Inc.
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a phase 2 randomized double blind placebo controlled study of adjunctive pimavanserin in patients with major depressive disorder and an inadequate response to therapy clarity
The Journal of Clinical Psychiatry, 2019Co-Authors: Maurizio Fava, Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Srdjan StankovicAbstract:OBJECTIVE: Pimavanserin is a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist. This phase 2 study examined the efficacy and safety of pimavanserin as adjunctive therapy in patients with major depressive disorder (MDD). METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study in patients with DSM-5-defined MDD and an inadequate response to a selective serotonin Reuptake Inhibitor (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). Using a 2-stage sequential parallel-comparison design, patients were initially randomized in a 3:1 ratio to placebo or pimavanserin added to ongoing SSRI or SNRI therapy; at 5 weeks, placebo nonresponders were re-randomized to placebo or pimavanserin for an additional 5 weeks. Key endpoints were change from baseline to the end of each stage in 17-item Hamilton Depression Rating Scale (HDRS-17) total score and Sheehan Disability Scale (SDS) score. RESULTS: Between December 2016 and October 2018, 207 patients were randomized. For the prespecified pooled Sequential Parallel Comparison Design analyses of Stages 1 and 2, the least squares (LS) mean (SE) difference for the HDRS-17 total score was -1.7 (0.85) (P = .039) and for the SDS score was -0.8 (0.29) (P = .004). At week 5 of Stage 1, LS mean (SE) difference for pimavanserin versus placebo was significant for changes on the HDRS-17 (-4.0 [1.09], P = .0003) and SDS (-1.2 [0.40], P = .0036) with effect sizes of 0.626 and 0.498, respectively. Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week. The most common adverse events with pimavanserin were dry mouth, nausea, and headache. CONCLUSIONS: Pimavanserin demonstrated robust efficacy in patients with MDD and an inadequate response to an SSRI or SNRI. Tolerability was consistent with previous experience. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03018340.
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remission with venlafaxine extended release or selective serotonin Reuptake Inhibitors in depressed patients a randomized open label study
The Primary Care Companion To The Journal of Clinical Psychiatry, 2011Co-Authors: Michael E Thase, Jeff Musgnung, Philip T Ninan, Madhukar H TrivediAbstract:Major depressive disorder (MDD) is a common, often chronic condition1 with annual costs in the United States estimated at $83.1 billion for inpatient hospitalizations, outpatient programs, suicide attempts, lost productivity, and impaired functioning at work, at home, or in social situations.2 More than half of all MDD patients who seek treatment do so in the primary care setting,3 where up to one-fifth of patients have significant depressive symptoms,4 and rates of MDD range from 6.6%5 to 12.5%.4 As a result, primary care physicians write at least 60% of all prescriptions for antidepressant medications.6 Efforts to improve the treatment of MDD and to reduce the burden of chronic and recurrent depression have led to the development of treatment algorithms such as those made available by the Agency for Healthcare Research and Quality7 and the American Psychiatric Association,8 as well as clinical practice guidelines that emphasize complete symptom remission as the therapeutic goal. Such guidelines represent “best practice” research focusing on the effects of treatments on outcomes, and their use allows primary care physicians to make evidence-based treatment decisions. However, relatively few clinical studies have directly compared the therapeutic effects of newer antidepressant treatments in the routine primary care setting. Despite the common use of selective serotonin Reuptake Inhibitors (SSRIs) as first-line agents for treating depression, the published literature suggests that outcomes in actual clinical practice are usually less than optimal.9–13 For example, the ARTIST study (A Randomized Trial Investigating SSRI Treatment), a large (N = 573) 9-month, open-label study designed and powered to compare the effectiveness of 3 widely prescribed SSRIs (paroxetine, fluoxetine, and sertraline), found that only 23% of patients achieved remission after 6 months of therapy.13 Venlafaxine extended release (ER), the first member of the Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) class of antidepressants, is one of the principal alternatives to the SSRIs. Similar to the SSRIs, venlafaxine ER has established efficacy in both depression14,15 and anxiety disorders16–20 and has demonstrated a more favorable tolerability and safety profile than the previous standard of first-line pharmacotherapy, the tricyclic antidepressants.21 By virtue of effects on both serotonergic and noradrenergic neurotransmission, some have argued that venlafaxine may have greater efficacy compared with the more selective SSRIs. A number of meta-analyses of a progressively expanding group of studies tend to support this hypothesis,14,22–26 although not all meta-analyses are in agreement.27–30 However relatively few of the studies included in these meta-analyses were conducted exclusively in primary care settings, and results of those studies, which were not powered to detect the modest between-group differences that would be expected in a comparison of active treatments, yielded inconsistent findings.31–34 To further evaluate differences in therapeutic outcomes between the SNRI and SSRI antidepressant classes in a primary care setting, we compared the efficacy and safety of antidepressant treatment with venlafaxine ER with physician's choice of the SSRIs citalopram, fluoxetine, paroxetine, or sertraline in patients with moderate to severe MDD. Clinical Points ♦Most people who receive treatment for major depressive disorder (MDD) are cared for by primary care physicians. ♦The selective serotonin Reuptake Inhibitors (SSRIs) are the most commonly used first-line treatments for patients with MDD. ♦Results of the current research suggest that venlafaxine, a Serotonin-Norepinephrine Reuptake Inhibitor, may have a modest efficacy advantage compared to SSRIs, which is consistent with evidence from some earlier studies.
George I Papakostas - One of the best experts on this subject based on the ideXlab platform.
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effect of adjunctive pimavanserin on suicidal ideation in patients with major depression analysis of the clarity study
Journal of Affective Disorders, 2020Co-Authors: Richard C Shelton, Marlene P Freeman, George I Papakostas, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Maurizio Fava, Manish K Jha, Keith Liu, Srdjan StankovicAbstract:Abstract Background Up to 15% of patients with major depressive disorder (MDD) attempt suicide and up to 2% complete suicide. This was a post-hoc analysis aimed to evaluate the risk of suicide ideation and behavior associated with adjunctive pimavanserin treatment in adults with MDD. Methods CLARITY was a randomized, double-blind, placebo-controlled study in patients with MDD and an inadequate response to a selective serotonin Reuptake Inhibitor (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). For this post-hoc analysis, the primary endpoint was mean change from baseline for HAMD item 3 (suicide). The incidence of suicidal ideation or behavior was also assessed from the Columbia-Suicide Severity Rating Scale (C-SSRS) and reports of adverse events. Results During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431). At any post-baseline assessment, suicidal ideation on the C-SSRS was reported in 28 (18.1%) of patients with placebo and 9 (17.3%) with pimavanserin during Stage 1 and in 7 (20.7%) with placebo and 4 (13.8%) with pimavanserin during Stage 2. No events of suicidal behavior were observed with either placebo or pimavanserin. Limitations : The post hoc nature, exclusion of patients with any history of suicide from the primary study, and the small number of patients who demonstrated evidence of suicidal ideation. Conclusions Adjunctive pimavanserin was not associated with an increase in suicidal ideation in patients with MDD. Further study is needed to verify these results.
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180 improvement of sexual function observed during treatment of major depressive disorder with adjunctive pimavanserin
Cns Spectrums, 2020Co-Authors: Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Troy Whitworth, Michael E Thase, Maurizio Fava, Srdjan StankovicAbstract:STUDY OBJECTIVES: Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY trial recently demonstrated the efficacy of adjunctive pimavanserin (PIM) for MDD when added to ongoing selective serotonin or Serotonin-Norepinephrine Reuptake Inhibitor (SSRI/SNRI) treatment. No new safety observations were reported in this study. This post-hoc analysis examines the potential impact of PIM treatment on sexual function. METHOD: Study methodology has been presented previously (APA 2019). Adult male and female patients with moderate-to-severe MDD were randomized to PIM 34 mg/day (n=51) or placebo (PBO, n=152) added to ongoing SSRI/SNRI treatment. Massachusetts General Hospital-Sexual Functioning Inventory (MGH-SFI) and Hamilton Depression Rating Scale, 17-item version (HAMD-17) item 14 (sexual interest) scores were examined by analysis of covariance. RESULTS: Adjunctive PIM resulted in significantly greater 5-week reduction (improvement) relative to SSRI/SNRI treatment plus placebo on mean MGH-SFI scores (difference -0.634, SE 0.167; P<0.001; effect size [ES], Cohen's d 0.614). Similarly, PIM resulted in greater improvement compared with placebo on individual MGH-SFI items that applied to both males and females: Interest in Sex (P=0.006; ES=0.483), Ability to Get Sexually Aroused/Excited (P=0.001; ES=0.560), Ability to Achieve Orgasm (P<0.001; ES=0.609), Overall Sexual Satisfaction (P=0.003; ES=0.524). HAMD-17 item 14 scores were also significantly more reduced (improved) with PIM (P<0.001; ES=0.574). CONCLUSIONS: These results underscore the potential of adjunctive PIM for improving sexual function in patients with MDD and inadequate response to SSRIs/SNRIs. Potential benefits should be confirmed in further studies. FUNDING ACKNOWLEDGEMENTS: ACADIA Pharmaceuticals Inc.
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180 improvement of sexual function observed during treatment of major depressive disorder with adjunctive pimavanserin
Cns Spectrums, 2020Co-Authors: Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Maurizio Fava, Manish K Jha, Keith Liu, Troy WhitworthAbstract:STUDY OBJECTIVES Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY trial recently demonstrated the efficacy of adjunctive pimavanserin (PIM) for MDD when added to ongoing selective serotonin or Serotonin-Norepinephrine Reuptake Inhibitor (SSRI/SNRI) treatment. No new safety observations were reported in this study. This post-hoc analysis examines the potential impact of PIM treatment on sexual function. METHOD Study methodology has been presented previously (APA 2019). Adult male and female patients with moderate-to-severe MDD were randomized to PIM 34 mg/day (n=51) or placebo (PBO, n=152) added to ongoing SSRI/SNRI treatment. Massachusetts General Hospital-Sexual Functioning Inventory (MGH-SFI) and Hamilton Depression Rating Scale, 17-item version (HAMD-17) item 14 (sexual interest) scores were examined by analysis of covariance. RESULTS Adjunctive PIM resulted in significantly greater 5-week reduction (improvement) relative to SSRI/SNRI treatment plus placebo on mean MGH-SFI scores (difference -0.634, SE 0.167; P<0.001; effect size [ES], Cohen's d 0.614). Similarly, PIM resulted in greater improvement compared with placebo on individual MGH-SFI items that applied to both males and females: Interest in Sex (P=0.006; ES=0.483), Ability to Get Sexually Aroused/Excited (P=0.001; ES=0.560), Ability to Achieve Orgasm (P<0.001; ES=0.609), Overall Sexual Satisfaction (P=0.003; ES=0.524). HAMD-17 item 14 scores were also significantly more reduced (improved) with PIM (P<0.001; ES=0.574). CONCLUSIONS These results underscore the potential of adjunctive PIM for improving sexual function in patients with MDD and inadequate response to SSRIs/SNRIs. Potential benefits should be confirmed in further studies. FUNDING ACKNOWLEDGEMENTS ACADIA Pharmaceuticals Inc.
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a phase 2 randomized double blind placebo controlled study of adjunctive pimavanserin in patients with major depressive disorder and an inadequate response to therapy clarity
The Journal of Clinical Psychiatry, 2019Co-Authors: Maurizio Fava, Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Srdjan StankovicAbstract:OBJECTIVE: Pimavanserin is a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist. This phase 2 study examined the efficacy and safety of pimavanserin as adjunctive therapy in patients with major depressive disorder (MDD). METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study in patients with DSM-5-defined MDD and an inadequate response to a selective serotonin Reuptake Inhibitor (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). Using a 2-stage sequential parallel-comparison design, patients were initially randomized in a 3:1 ratio to placebo or pimavanserin added to ongoing SSRI or SNRI therapy; at 5 weeks, placebo nonresponders were re-randomized to placebo or pimavanserin for an additional 5 weeks. Key endpoints were change from baseline to the end of each stage in 17-item Hamilton Depression Rating Scale (HDRS-17) total score and Sheehan Disability Scale (SDS) score. RESULTS: Between December 2016 and October 2018, 207 patients were randomized. For the prespecified pooled Sequential Parallel Comparison Design analyses of Stages 1 and 2, the least squares (LS) mean (SE) difference for the HDRS-17 total score was -1.7 (0.85) (P = .039) and for the SDS score was -0.8 (0.29) (P = .004). At week 5 of Stage 1, LS mean (SE) difference for pimavanserin versus placebo was significant for changes on the HDRS-17 (-4.0 [1.09], P = .0003) and SDS (-1.2 [0.40], P = .0036) with effect sizes of 0.626 and 0.498, respectively. Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week. The most common adverse events with pimavanserin were dry mouth, nausea, and headache. CONCLUSIONS: Pimavanserin demonstrated robust efficacy in patients with MDD and an inadequate response to an SSRI or SNRI. Tolerability was consistent with previous experience. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03018340.
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a meta analysis of clinical trials comparing milnacipran a serotonin norepinephrine Reuptake Inhibitor with a selective serotonin Reuptake Inhibitor for the treatment of major depressive disorder
European Neuropsychopharmacology, 2007Co-Authors: George I Papakostas, Maurizio FavaAbstract:Abstract Context Over the past few years, a number of studies have emerged suggesting that the treatment of major depressive disorder (MDD) with antidepressants which enhance both noradrenergic as well as serotonergic neurotransmission may result in higher response or remission rates than treatment with antidepressants which selectively enhance serotonergic neurotransmission. Objective The objective of this paper was to compare response rates among patients with MDD treated with either milnacipran, an antidepressant thought to simultaneously enhance both noradrenergic and serotonergic neurotransmission, or a selective serotonin Reuptake Inhibitor (SSRI). Data sources Medline/Pubmed were searched. No year of publication or language limits were used. Study selection Double-blind, randomized clinical trials comparing milnacipran with an SSRI for the treatment of MDD. Data extraction Data were extracted with the use of a pre-coded form. Data synthesis Analyses were performed comparing response rates between the two antidepressant agents. Data from 6 reports involving a total of 1082 outpatients with MDD were identified and combined using a random-effects model. Patients randomized to treatment with milnacipran were as likely to experience clinical response as patients randomized to treatment with an SSRI according to the MADRS (RR = 1.04, 95% CI: 0.88–1.23, p = 0.533) or the HDRS (RR = 1.06, 95% CI: 0.90–1.24, p = 0.456) for the random effects model. Simply pooling MADRS-based response rates between the two agents revealed a 58.9% response rate for milnacipran and a 58.3% response rate for the SSRIs. Similarly, HDRS-based response rates were 59.7% and 57.5%. There was also no difference in overall discontinuation rates (RR = 0.93; 95% CI: 0.76–1.14; p = 0.506), the rate of discontinuation due to adverse events (RR = 0.77; 95% CI: 0.55–1.1; p = 0.157), or the rate of discontinuation due to inefficacy (RR = 0.98; 95% CI: 0.7–1.38; p = 0.95) between the two groups. Conclusions These results suggest that milnacipran and the SSRIs do not differ with respect to their overall efficacy in the treatment of MDD.
Matthew J Miller - One of the best experts on this subject based on the ideXlab platform.
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serotonin norepinephrine Reuptake Inhibitor and selective serotonin Reuptake Inhibitor use and risk of fractures a new user cohort study among us adults aged 50 years and older
CNS Drugs, 2015Co-Authors: Amy Lanteigne, Yi Han Sheu, Virginia Pate, Deborah R Azrael, Matthew J Miller, Til Sturmer, Sonja A. SwansonAbstract:Background Antidepressants may increase the risk of fractures by disrupting sensory-motor function, thereby increasing the risk of falls, and by decreasing bone mineral density and consequently increasing the fall- or impact-related risk of fracture. Selective serotonin Reuptake Inhibitor (SSRI) antidepressants appear to increase fracture risk relative to no treatment, while less is known about the effect of serotonin–norepinephrine Reuptake Inhibitor (SNRI) antidepressants, despite SNRIs being prescribed with increasing frequency. No prior study has directly examined how fracture risk differs among patients initiating SNRIs versus those initiating SSRIs.
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serotonin norepinephrine Reuptake Inhibitor and selective serotonin Reuptake Inhibitor use and risk of fractures a new user cohort study among us adults aged 50 years and older
CNS Drugs, 2015Co-Authors: Amy Lanteigne, Yi Han Sheu, Virginia Pate, Deborah R Azrael, Matthew J Miller, Til Sturmer, Sonja A. SwansonAbstract:Antidepressants may increase the risk of fractures by disrupting sensory-motor function, thereby increasing the risk of falls, and by decreasing bone mineral density and consequently increasing the fall- or impact-related risk of fracture. Selective serotonin Reuptake Inhibitor (SSRI) antidepressants appear to increase fracture risk relative to no treatment, while less is known about the effect of serotonin–norepinephrine Reuptake Inhibitor (SNRI) antidepressants, despite SNRIs being prescribed with increasing frequency. No prior study has directly examined how fracture risk differs among patients initiating SNRIs versus those initiating SSRIs. The objective of this study was to assess the effect of SNRI versus SSRI initiation on fracture rates. Data were derived from a PharMetrics claims database, 1998–2010, which is comprised of commercial health plan information obtained from managed care plans throughout the US. We constructed a cohort of patients aged 50 years or older initiating either of the two drug classes (SSRI, N = 335,146; SNRI, N = 61,612). Standardized mortality weighting and Cox proportional hazards regression were used to estimate hazard ratios (HRs) for fractures by antidepressant class. In weighted analyses, the fracture rates were approximately equal in SNRI and SSRI initiators: HRs for the first 1- and 5-year periods following initiation were 1.11 [95 % confidence interval (CI) 0.92–1.36] and 1.06 (95 % CI 0.90–1.26), respectively. For the subgroup of patients with depression who initiated on either SNRIs or SSRIs, those initiating SNRIs had a modestly, but not significantly, elevated fracture risk compared with those who initiated on SSRIs [HR 1.31 (95 % CI 0.95–1.79)]. We found no evidence that initiating SNRIs rather than SSRIs materially influenced fracture risk among a cohort of middle-aged and older adults.
Madhukar H Trivedi - One of the best experts on this subject based on the ideXlab platform.
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effect of adjunctive pimavanserin on suicidal ideation in patients with major depression analysis of the clarity study
Journal of Affective Disorders, 2020Co-Authors: Richard C Shelton, Marlene P Freeman, George I Papakostas, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Maurizio Fava, Manish K Jha, Keith Liu, Srdjan StankovicAbstract:Abstract Background Up to 15% of patients with major depressive disorder (MDD) attempt suicide and up to 2% complete suicide. This was a post-hoc analysis aimed to evaluate the risk of suicide ideation and behavior associated with adjunctive pimavanserin treatment in adults with MDD. Methods CLARITY was a randomized, double-blind, placebo-controlled study in patients with MDD and an inadequate response to a selective serotonin Reuptake Inhibitor (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). For this post-hoc analysis, the primary endpoint was mean change from baseline for HAMD item 3 (suicide). The incidence of suicidal ideation or behavior was also assessed from the Columbia-Suicide Severity Rating Scale (C-SSRS) and reports of adverse events. Results During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431). At any post-baseline assessment, suicidal ideation on the C-SSRS was reported in 28 (18.1%) of patients with placebo and 9 (17.3%) with pimavanserin during Stage 1 and in 7 (20.7%) with placebo and 4 (13.8%) with pimavanserin during Stage 2. No events of suicidal behavior were observed with either placebo or pimavanserin. Limitations : The post hoc nature, exclusion of patients with any history of suicide from the primary study, and the small number of patients who demonstrated evidence of suicidal ideation. Conclusions Adjunctive pimavanserin was not associated with an increase in suicidal ideation in patients with MDD. Further study is needed to verify these results.
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180 improvement of sexual function observed during treatment of major depressive disorder with adjunctive pimavanserin
Cns Spectrums, 2020Co-Authors: Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Troy Whitworth, Michael E Thase, Maurizio Fava, Srdjan StankovicAbstract:STUDY OBJECTIVES: Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY trial recently demonstrated the efficacy of adjunctive pimavanserin (PIM) for MDD when added to ongoing selective serotonin or Serotonin-Norepinephrine Reuptake Inhibitor (SSRI/SNRI) treatment. No new safety observations were reported in this study. This post-hoc analysis examines the potential impact of PIM treatment on sexual function. METHOD: Study methodology has been presented previously (APA 2019). Adult male and female patients with moderate-to-severe MDD were randomized to PIM 34 mg/day (n=51) or placebo (PBO, n=152) added to ongoing SSRI/SNRI treatment. Massachusetts General Hospital-Sexual Functioning Inventory (MGH-SFI) and Hamilton Depression Rating Scale, 17-item version (HAMD-17) item 14 (sexual interest) scores were examined by analysis of covariance. RESULTS: Adjunctive PIM resulted in significantly greater 5-week reduction (improvement) relative to SSRI/SNRI treatment plus placebo on mean MGH-SFI scores (difference -0.634, SE 0.167; P<0.001; effect size [ES], Cohen's d 0.614). Similarly, PIM resulted in greater improvement compared with placebo on individual MGH-SFI items that applied to both males and females: Interest in Sex (P=0.006; ES=0.483), Ability to Get Sexually Aroused/Excited (P=0.001; ES=0.560), Ability to Achieve Orgasm (P<0.001; ES=0.609), Overall Sexual Satisfaction (P=0.003; ES=0.524). HAMD-17 item 14 scores were also significantly more reduced (improved) with PIM (P<0.001; ES=0.574). CONCLUSIONS: These results underscore the potential of adjunctive PIM for improving sexual function in patients with MDD and inadequate response to SSRIs/SNRIs. Potential benefits should be confirmed in further studies. FUNDING ACKNOWLEDGEMENTS: ACADIA Pharmaceuticals Inc.
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180 improvement of sexual function observed during treatment of major depressive disorder with adjunctive pimavanserin
Cns Spectrums, 2020Co-Authors: Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Maurizio Fava, Manish K Jha, Keith Liu, Troy WhitworthAbstract:STUDY OBJECTIVES Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY trial recently demonstrated the efficacy of adjunctive pimavanserin (PIM) for MDD when added to ongoing selective serotonin or Serotonin-Norepinephrine Reuptake Inhibitor (SSRI/SNRI) treatment. No new safety observations were reported in this study. This post-hoc analysis examines the potential impact of PIM treatment on sexual function. METHOD Study methodology has been presented previously (APA 2019). Adult male and female patients with moderate-to-severe MDD were randomized to PIM 34 mg/day (n=51) or placebo (PBO, n=152) added to ongoing SSRI/SNRI treatment. Massachusetts General Hospital-Sexual Functioning Inventory (MGH-SFI) and Hamilton Depression Rating Scale, 17-item version (HAMD-17) item 14 (sexual interest) scores were examined by analysis of covariance. RESULTS Adjunctive PIM resulted in significantly greater 5-week reduction (improvement) relative to SSRI/SNRI treatment plus placebo on mean MGH-SFI scores (difference -0.634, SE 0.167; P<0.001; effect size [ES], Cohen's d 0.614). Similarly, PIM resulted in greater improvement compared with placebo on individual MGH-SFI items that applied to both males and females: Interest in Sex (P=0.006; ES=0.483), Ability to Get Sexually Aroused/Excited (P=0.001; ES=0.560), Ability to Achieve Orgasm (P<0.001; ES=0.609), Overall Sexual Satisfaction (P=0.003; ES=0.524). HAMD-17 item 14 scores were also significantly more reduced (improved) with PIM (P<0.001; ES=0.574). CONCLUSIONS These results underscore the potential of adjunctive PIM for improving sexual function in patients with MDD and inadequate response to SSRIs/SNRIs. Potential benefits should be confirmed in further studies. FUNDING ACKNOWLEDGEMENTS ACADIA Pharmaceuticals Inc.
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a phase 2 randomized double blind placebo controlled study of adjunctive pimavanserin in patients with major depressive disorder and an inadequate response to therapy clarity
The Journal of Clinical Psychiatry, 2019Co-Authors: Maurizio Fava, Marlene P Freeman, George I Papakostas, Richard C Shelton, Madhukar H Trivedi, Bryan Dirks, Michael E Thase, Srdjan StankovicAbstract:OBJECTIVE: Pimavanserin is a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist. This phase 2 study examined the efficacy and safety of pimavanserin as adjunctive therapy in patients with major depressive disorder (MDD). METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study in patients with DSM-5-defined MDD and an inadequate response to a selective serotonin Reuptake Inhibitor (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). Using a 2-stage sequential parallel-comparison design, patients were initially randomized in a 3:1 ratio to placebo or pimavanserin added to ongoing SSRI or SNRI therapy; at 5 weeks, placebo nonresponders were re-randomized to placebo or pimavanserin for an additional 5 weeks. Key endpoints were change from baseline to the end of each stage in 17-item Hamilton Depression Rating Scale (HDRS-17) total score and Sheehan Disability Scale (SDS) score. RESULTS: Between December 2016 and October 2018, 207 patients were randomized. For the prespecified pooled Sequential Parallel Comparison Design analyses of Stages 1 and 2, the least squares (LS) mean (SE) difference for the HDRS-17 total score was -1.7 (0.85) (P = .039) and for the SDS score was -0.8 (0.29) (P = .004). At week 5 of Stage 1, LS mean (SE) difference for pimavanserin versus placebo was significant for changes on the HDRS-17 (-4.0 [1.09], P = .0003) and SDS (-1.2 [0.40], P = .0036) with effect sizes of 0.626 and 0.498, respectively. Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week. The most common adverse events with pimavanserin were dry mouth, nausea, and headache. CONCLUSIONS: Pimavanserin demonstrated robust efficacy in patients with MDD and an inadequate response to an SSRI or SNRI. Tolerability was consistent with previous experience. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03018340.
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remission with venlafaxine extended release or selective serotonin Reuptake Inhibitors in depressed patients a randomized open label study
The Primary Care Companion To The Journal of Clinical Psychiatry, 2011Co-Authors: Michael E Thase, Jeff Musgnung, Philip T Ninan, Madhukar H TrivediAbstract:Major depressive disorder (MDD) is a common, often chronic condition1 with annual costs in the United States estimated at $83.1 billion for inpatient hospitalizations, outpatient programs, suicide attempts, lost productivity, and impaired functioning at work, at home, or in social situations.2 More than half of all MDD patients who seek treatment do so in the primary care setting,3 where up to one-fifth of patients have significant depressive symptoms,4 and rates of MDD range from 6.6%5 to 12.5%.4 As a result, primary care physicians write at least 60% of all prescriptions for antidepressant medications.6 Efforts to improve the treatment of MDD and to reduce the burden of chronic and recurrent depression have led to the development of treatment algorithms such as those made available by the Agency for Healthcare Research and Quality7 and the American Psychiatric Association,8 as well as clinical practice guidelines that emphasize complete symptom remission as the therapeutic goal. Such guidelines represent “best practice” research focusing on the effects of treatments on outcomes, and their use allows primary care physicians to make evidence-based treatment decisions. However, relatively few clinical studies have directly compared the therapeutic effects of newer antidepressant treatments in the routine primary care setting. Despite the common use of selective serotonin Reuptake Inhibitors (SSRIs) as first-line agents for treating depression, the published literature suggests that outcomes in actual clinical practice are usually less than optimal.9–13 For example, the ARTIST study (A Randomized Trial Investigating SSRI Treatment), a large (N = 573) 9-month, open-label study designed and powered to compare the effectiveness of 3 widely prescribed SSRIs (paroxetine, fluoxetine, and sertraline), found that only 23% of patients achieved remission after 6 months of therapy.13 Venlafaxine extended release (ER), the first member of the Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) class of antidepressants, is one of the principal alternatives to the SSRIs. Similar to the SSRIs, venlafaxine ER has established efficacy in both depression14,15 and anxiety disorders16–20 and has demonstrated a more favorable tolerability and safety profile than the previous standard of first-line pharmacotherapy, the tricyclic antidepressants.21 By virtue of effects on both serotonergic and noradrenergic neurotransmission, some have argued that venlafaxine may have greater efficacy compared with the more selective SSRIs. A number of meta-analyses of a progressively expanding group of studies tend to support this hypothesis,14,22–26 although not all meta-analyses are in agreement.27–30 However relatively few of the studies included in these meta-analyses were conducted exclusively in primary care settings, and results of those studies, which were not powered to detect the modest between-group differences that would be expected in a comparison of active treatments, yielded inconsistent findings.31–34 To further evaluate differences in therapeutic outcomes between the SNRI and SSRI antidepressant classes in a primary care setting, we compared the efficacy and safety of antidepressant treatment with venlafaxine ER with physician's choice of the SSRIs citalopram, fluoxetine, paroxetine, or sertraline in patients with moderate to severe MDD. Clinical Points ♦Most people who receive treatment for major depressive disorder (MDD) are cared for by primary care physicians. ♦The selective serotonin Reuptake Inhibitors (SSRIs) are the most commonly used first-line treatments for patients with MDD. ♦Results of the current research suggest that venlafaxine, a Serotonin-Norepinephrine Reuptake Inhibitor, may have a modest efficacy advantage compared to SSRIs, which is consistent with evidence from some earlier studies.
