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Stephen Kaplita - One of the best experts on this subject based on the ideXlab platform.
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double blind placebo substitution study of Nefazodone in the prevention of relapse during continuation treatment of outpatients with major depression
International Clinical Psychopharmacology, 1999Co-Authors: Alan D Feiger, Terry T. Kensler, R Bielski, James Bremner, Jon F Heiser, Madhukar H Trivedi, Charles S Wilcox, Douglas L Roberts, Robert D Mcquade, Stephen KaplitaAbstract:The efficacy of Nefazodone in prevention of relapse of depression was evaluated in a 36-week double-blind, placebo-substitution, continuation treatment trial. After 16 weeks of acute, single-blind treatment with Nefazodone, 131 patients responding to treatment and in stable remission were randomized in a 36-week double-blind trial to either Nefazodone (n = 65) or placebo (n = 66). Patients were defined as having relapsed if they had a total score ≥ 18 on the 17-item Hamilton Depression Scale on two consecutive visits or if they discontinued treatment for lack of efficacy. Relapse rates were significantly lower for patients randomized to continued Nefazodone treatment than for patients switched to placebo. Kaplan-Meier estimates of relapse rates 9 months (36 weeks) after the end of acute treatment were 1.8% for Nefazodone versus 18.3% for placebo (P = 0.009) by the Hamilton Depression Scale and 17.3% versus 32.8% (P = 0.028) by discontinuation for lack of efficacy. The mean modal dose of Nefazodone was 412 mg/day at study endpoint. These results demonstrate the clinical effectiveness of up to 1 year's treatment (16 weeks acute and 36 weeks continuation) with Nefazodone in depressed patients. Long-term efficacy of Nefazodone was accompanied by a good safety profile without any weight gain and with minimal symptoms of withdrawal upon abrupt discontinuation of treatment.
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Comparative effects of Nefazodone and fluoxetine on sleep in outpatients with major depressive disorder
Biological psychiatry, 1998Co-Authors: A. John Rush, Gerald W. Vogel, Stephen Kaplita, Roseanne Armitage, J. Christian Gillin, Kimberly A. Yonkers, Andrew Winokur, Harvey Moldofsky, Jonathan B Fleming, Jacques MontplaisirAbstract:Abstract Background: Sleep disturbances are common in major depressive disorder. In previous open-label trials, Nefazodone improved sleep continuity and increased rapid eye movement (REM) sleep, while not affecting stage 3/4 sleep or REM latency; in contrast, fluoxetine suppressed REM sleep. This study compared the objective and subjective effects of Nefazodone and fluoxetine on sleep. Methods: This paper reports combined results of three identical, multisite, randomized, double-blind, 8-week, acute-phase trials comparing Nefazodone ( n = 64) with fluoxetine ( n = 61) in outpatients with nonpsychotic major depressive disorder and insomnia. Sleep electroencephalographic (EEG) recordings were gathered at baseline and weeks 2, 4, and 8. Clinical ratings were obtained at weeks 1–4, 6, and 8. Results: Nefazodone and fluoxetine were equally effective in reducing depressive symptoms; however, Nefazodone differentially and progressively increased (while fluoxetine reduced) sleep efficiency and reduced (while fluoxetine increased) the number of awakenings in a linear fashion over the 8-week trial. Fluoxetine, but not Nefazodone, prolonged REM latency and suppressed REM sleep. Nefazodone significantly increased total REM sleep time. Clinical evaluations of sleep quality were significantly improved with Nefazodone compared with fluoxetine. Conclusions: Nefazodone and fluoxetine were equally effective antidepressants. Nefazodone was associated with normal objective, and clinician- and patient-rated assessments of sleep when compared with fluoxetine. These differential sleep EEG effects are consstent with the notion that Nefazodone and fluoxetine may have somewhat different modes and spectra of action.
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Nefazodone and REM Sleep: How Do Antidepressant Drugs Decrease REM Sleep?
Sleep, 1998Co-Authors: Gerald W. Vogel, Jonathan Cohen, Deidre Mullis, Terry T. Kensler, Stephen KaplitaAbstract:In previous uncontrolled studies, Nefazodone, a new antidepressant drug, increased REM sleep or had no effect on REM sleep. We report a double-blind, placebo-controlled, parallel group study on effects of Nefazodone (N) on polysomnographic sleep variables in healthy human volunteers. Nefazodone was administered for 16 consecutive days, and nocturnal sleep, as well as multiple sleep latency test (MSLT), was monitored before, during, and after N administration. We found that N had no effect on any measured REM sleep variable including REM sleep duration, REM density, and nocturnal REM sleep distribution. Nefazodone also had no significant effect on nocturnal total sleep time or NREM variables, but increased daytime alertness measured by the MSLT. Since N is a potent serotonin reuptake blocker, the present findings that N had no effect on REM sleep cast doubt on the hypothesis that antidepressant drugs decrease REM sleep by increasing serotonergic neurotransmission. A review of other relevant work also casts doubt on this hypothesis.
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A double-blind comparison of Nefazodone, imipramine, and placebo in major depression
The Journal of clinical psychiatry, 1994Co-Authors: R. Fontaine, Terry T. Kensler, Stephen Kaplita, D L Roberts, A. Ontiveros, R. Elie, J. A. Ecker, G. FaludiAbstract:BACKGROUND Nefazodone is a 5-HT2-receptor antagonist and serotonin (5-HT) selective reuptake inhibitor. This study evaluates the safety and efficacy of Nefazodone in patients with major depressive disorder (MDD) in comparison to imipramine and placebo treatments. It also compares two dose ranges of Nefazodone to investigate its optimal dose range. METHOD Nefazodone was evaluated in a 6-week, double-blind trial of novel design involving 180 patients meeting Research Diagnostic Criteria for major depressive disorder and having a minimum pretreatment score of 22 on the first 17 items of the Hamilton Rating Scale for Depression (HAM-D). Patients were randomly assigned to placebo (2-10 capsules/day), imipramine (50-250 mg/day), or Nefazodone in two dose ranges (50-250 mg/day or 100-500 mg/day). RESULTS Improvement on depression measures with Nefazodone in the 100-500-mg/day dose range (endpoint mean = 460 mg/day) and imipramine (endpoint mean = 214 mg/day) exceeded that with placebo. Some benefit was also observed in the Nefazodone 50-250-mg/day treatment group (endpoint mean = 242 mg/day), but it was suboptimal. Evidence of Nefazodone's efficacy as an antidepressant was consistently observed on physician- (HAM-D, Clinical Global Impressions [CGI]) and patient-rated (CGI-patient rated) scales. By patient self-report, improvement of anxiety symptoms associated with depression was evident with Nefazodone as early as the first week of treatment, and benefit was seen with both Nefazodone dosage groups. Analyses of the physician's global assessments of therapeutic effect and side effects at end of treatment showed therapeutic benefit for both Nefazodone and imipramine treatments; however, patients in the Nefazodone treatment groups were significantly less troubled by adverse experiences than were imipramine-treated patients, resulting in a lower dropout rate for adverse experience. CONCLUSION Nefazodone is a well-tolerated and effective antidepressant for the treatment of major depressive disorder.
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Effects Of Nefazodone On Sleep Architecture And Daytime Alertness
Neuropsychopharmacology, 1994Co-Authors: Gerald W. Vogel, Jonathan Cohen, Stephen Kaplita, Martha M Frescura, Ute Schwiderski, Terry T. KenslerAbstract:Nefazodone is a new antidepressant drug that is both a 5-HT2 antagonist and a serotonin reuptake inhibitor. It has been demonstrated to be safe and effective for the treatment of patients with major depression. This double-blind, randomized, parallel group study compared the effects of Nefazodone and placebo on sleep architecture and daytime alertness in 22 normal volunteers. Polysomnographic recordings were obtained in the sleep laboratory for each subject (11 per treatment group) during a 3-night placebo run-in period, 8 nights of a 2-week treatment period, and 2 nights of placebo washout. Nightly time in bed was controlled at 480 minutes for all subjects. Following the single-blind placebo run-in period, subjects were randomized to receive either Nefazodone or placebo. Nefazodone was dosed at 100 mg BID during the first treatment week and 200 mg BID during the second week. Daytime alertness was evaluated using the Multiple Sleep Latency Test (MSLT) before, during, and after treatment. Compared with placebo, Nefazodone did not disrupt normal sleep architecture and, unlike most other antidepressant drugs, it had no effect on REM sleep (time, density, or latency). Although Nefazodone is mildly sedating clinically, it had no overall effect on total sleep time (or sleep efficiency) or the number of awakenings. In addition, all other aspects of sleep architecture, including the proportion of slow wave (stage 3 and 4) sleep, were unchanged after two weeks of treatment. The MSLT showed no evidence that Nefazodone caused daytime sleepiness.
John C Voris - One of the best experts on this subject based on the ideXlab platform.
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Nefazodone in the treatment of patients with post-traumatic stress disorder.
Expert review of neurotherapeutics, 2002Co-Authors: Rachel H Sharpe, John C VorisAbstract:Post-traumatic stress disorder occurs in patients who have undergone a traumatic experience and manifests itself through a cluster of symptoms, including re-experiencing, avoidance and hyperarousal. Post-traumatic stress disorder is commonly found among veterans of war and victims of sexual trauma, natural disasters and accidents. Nefazodone is a medication that has an FDA-approved indication for treating depression. Nefazodone has also been reported to be efficacious in treating post-traumatic stress disorder. Despite recent reports of hepatotoxicity, when used appropriately, Nefazodone is generally as well-tolerated as the medications currently FDA-indicated for post-traumatic stress disorder, the selective serotonin reuptake inhibitors. Through its mechanism inhibiting neuronal uptake of serotonin and norepinephrine and as a potent postsynaptic serotonergic antagonist, Nefazodone has proven to be effective in treating post-traumatic stress disorder in several open-label trials. The results of such tria...
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Nefazodone: single versus twice daily dose.
Pharmacotherapy, 1998Co-Authors: John C Voris, Glen N. Shaurette, Praxedes S. Sebastian, Louise A. Will‐wallaceAbstract:This pilot study involved six men with major depression treated with Nefazodone dosed either twice/day or once/day at bedtime. Depression was rated before Nefazodone therapy and at 4 weeks by the self-report version of the Hamilton Depression Rating Scale. A simple 10-cm visual analog side effect scale for daytime drowsiness was completed at the latter time. Dosages of Nefazodone were at least 400 mg/day. The results suggest that Nefazodone given once/day at bedtime may be as effective as the currently accepted twice/day regimen, with less daytime drowsiness.
Terry T. Kensler - One of the best experts on this subject based on the ideXlab platform.
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double blind placebo substitution study of Nefazodone in the prevention of relapse during continuation treatment of outpatients with major depression
International Clinical Psychopharmacology, 1999Co-Authors: Alan D Feiger, Terry T. Kensler, R Bielski, James Bremner, Jon F Heiser, Madhukar H Trivedi, Charles S Wilcox, Douglas L Roberts, Robert D Mcquade, Stephen KaplitaAbstract:The efficacy of Nefazodone in prevention of relapse of depression was evaluated in a 36-week double-blind, placebo-substitution, continuation treatment trial. After 16 weeks of acute, single-blind treatment with Nefazodone, 131 patients responding to treatment and in stable remission were randomized in a 36-week double-blind trial to either Nefazodone (n = 65) or placebo (n = 66). Patients were defined as having relapsed if they had a total score ≥ 18 on the 17-item Hamilton Depression Scale on two consecutive visits or if they discontinued treatment for lack of efficacy. Relapse rates were significantly lower for patients randomized to continued Nefazodone treatment than for patients switched to placebo. Kaplan-Meier estimates of relapse rates 9 months (36 weeks) after the end of acute treatment were 1.8% for Nefazodone versus 18.3% for placebo (P = 0.009) by the Hamilton Depression Scale and 17.3% versus 32.8% (P = 0.028) by discontinuation for lack of efficacy. The mean modal dose of Nefazodone was 412 mg/day at study endpoint. These results demonstrate the clinical effectiveness of up to 1 year's treatment (16 weeks acute and 36 weeks continuation) with Nefazodone in depressed patients. Long-term efficacy of Nefazodone was accompanied by a good safety profile without any weight gain and with minimal symptoms of withdrawal upon abrupt discontinuation of treatment.
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Nefazodone and REM Sleep: How Do Antidepressant Drugs Decrease REM Sleep?
Sleep, 1998Co-Authors: Gerald W. Vogel, Jonathan Cohen, Deidre Mullis, Terry T. Kensler, Stephen KaplitaAbstract:In previous uncontrolled studies, Nefazodone, a new antidepressant drug, increased REM sleep or had no effect on REM sleep. We report a double-blind, placebo-controlled, parallel group study on effects of Nefazodone (N) on polysomnographic sleep variables in healthy human volunteers. Nefazodone was administered for 16 consecutive days, and nocturnal sleep, as well as multiple sleep latency test (MSLT), was monitored before, during, and after N administration. We found that N had no effect on any measured REM sleep variable including REM sleep duration, REM density, and nocturnal REM sleep distribution. Nefazodone also had no significant effect on nocturnal total sleep time or NREM variables, but increased daytime alertness measured by the MSLT. Since N is a potent serotonin reuptake blocker, the present findings that N had no effect on REM sleep cast doubt on the hypothesis that antidepressant drugs decrease REM sleep by increasing serotonergic neurotransmission. A review of other relevant work also casts doubt on this hypothesis.
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A double-blind comparison of Nefazodone, imipramine, and placebo in major depression
The Journal of clinical psychiatry, 1994Co-Authors: R. Fontaine, Terry T. Kensler, Stephen Kaplita, D L Roberts, A. Ontiveros, R. Elie, J. A. Ecker, G. FaludiAbstract:BACKGROUND Nefazodone is a 5-HT2-receptor antagonist and serotonin (5-HT) selective reuptake inhibitor. This study evaluates the safety and efficacy of Nefazodone in patients with major depressive disorder (MDD) in comparison to imipramine and placebo treatments. It also compares two dose ranges of Nefazodone to investigate its optimal dose range. METHOD Nefazodone was evaluated in a 6-week, double-blind trial of novel design involving 180 patients meeting Research Diagnostic Criteria for major depressive disorder and having a minimum pretreatment score of 22 on the first 17 items of the Hamilton Rating Scale for Depression (HAM-D). Patients were randomly assigned to placebo (2-10 capsules/day), imipramine (50-250 mg/day), or Nefazodone in two dose ranges (50-250 mg/day or 100-500 mg/day). RESULTS Improvement on depression measures with Nefazodone in the 100-500-mg/day dose range (endpoint mean = 460 mg/day) and imipramine (endpoint mean = 214 mg/day) exceeded that with placebo. Some benefit was also observed in the Nefazodone 50-250-mg/day treatment group (endpoint mean = 242 mg/day), but it was suboptimal. Evidence of Nefazodone's efficacy as an antidepressant was consistently observed on physician- (HAM-D, Clinical Global Impressions [CGI]) and patient-rated (CGI-patient rated) scales. By patient self-report, improvement of anxiety symptoms associated with depression was evident with Nefazodone as early as the first week of treatment, and benefit was seen with both Nefazodone dosage groups. Analyses of the physician's global assessments of therapeutic effect and side effects at end of treatment showed therapeutic benefit for both Nefazodone and imipramine treatments; however, patients in the Nefazodone treatment groups were significantly less troubled by adverse experiences than were imipramine-treated patients, resulting in a lower dropout rate for adverse experience. CONCLUSION Nefazodone is a well-tolerated and effective antidepressant for the treatment of major depressive disorder.
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Effects Of Nefazodone On Sleep Architecture And Daytime Alertness
Neuropsychopharmacology, 1994Co-Authors: Gerald W. Vogel, Jonathan Cohen, Stephen Kaplita, Martha M Frescura, Ute Schwiderski, Terry T. KenslerAbstract:Nefazodone is a new antidepressant drug that is both a 5-HT2 antagonist and a serotonin reuptake inhibitor. It has been demonstrated to be safe and effective for the treatment of patients with major depression. This double-blind, randomized, parallel group study compared the effects of Nefazodone and placebo on sleep architecture and daytime alertness in 22 normal volunteers. Polysomnographic recordings were obtained in the sleep laboratory for each subject (11 per treatment group) during a 3-night placebo run-in period, 8 nights of a 2-week treatment period, and 2 nights of placebo washout. Nightly time in bed was controlled at 480 minutes for all subjects. Following the single-blind placebo run-in period, subjects were randomized to receive either Nefazodone or placebo. Nefazodone was dosed at 100 mg BID during the first treatment week and 200 mg BID during the second week. Daytime alertness was evaluated using the Multiple Sleep Latency Test (MSLT) before, during, and after treatment. Compared with placebo, Nefazodone did not disrupt normal sleep architecture and, unlike most other antidepressant drugs, it had no effect on REM sleep (time, density, or latency). Although Nefazodone is mildly sedating clinically, it had no overall effect on total sleep time (or sleep efficiency) or the number of awakenings. In addition, all other aspects of sleep architecture, including the proportion of slow wave (stage 3 and 4) sleep, were unchanged after two weeks of treatment. The MSLT showed no evidence that Nefazodone caused daytime sleepiness.
Jonathan R T Davidson - One of the best experts on this subject based on the ideXlab platform.
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Three- to Four-Year Follow-Up to an Open Trial of Nefazodone for Combat-Related Posttraumatic Stress Disorder
Annals of Clinical Psychiatry, 2002Co-Authors: Michael A Hertzberg, Michelle E. Feldman, Jean C. Beckham, Scott D. Moore, Jonathan R T DavidsonAbstract:Multiyear (37–51 months) follow-up data was obtained on patients who had participated in an open label trial of Nefazodone that originally showed Nefazodone may be useful for symptom management in posttraumatic stress disorder (PTSD) patients. Ten patients with combat-related DSM-IV posttraumatic stress disorder (PTSD) entered an open-label 12-week trial of Nefazodone, beginning with 100 mg/day and increasing as necessary to achieve a maximal response or until reaching a maximum dosage of 600 mg/day. All 10 patients were followed for over 3–4 years and used Nefazodone with dosages of 400–600 mg a day. The entire dosage was shifted to bedtime to facilitate sleep in 7 patients. Data on PTSD symptoms, depression, sleep, and anger were examined. Nefazodone was well tolerated and no significant changes in sexual function were reported. All participants reported compliance with the prescribed Nefazodone over 3–4 years. Nine patients reported that it remained effective, and expressed a desire to remain on the medication. On the basis of clinician global impression ratings (compared to baseline), 10 patients were rated as much improved at 12 weeks. Seven of the 10 patients continued to be much improved, 2 were minimally improved, and 1 was rated as worse (compared to baseline assessment) on 3–4-year follow-up. At 3–4-year follow-up, improvements in PTSD symptoms, sleep, and anger were maintained. These improvements were statistically significant with moderate-to-large effect sizes. These data suggest that clinical improvement in PTSD patients administered Nefazodone may be maintained with continued treatment. The medication was tolerated well in long-term treatment, compliance was high, and improvement was maintained over several years. Length of treatment, appropriate dose, long-term efficacy, and compliance are all clinically significant issues with little guiding data available. Controlled studies are needed to (a) further investigate the long-term efficacy of Nefazodone in the treatment of PTSD; (b) provide information for length of treatment guidelines; and (c) document if discontinuation is possible and efficacious.
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Nefazodone in post traumatic stress disorder results from six open label trials
International Clinical Psychopharmacology, 1999Co-Authors: Rosario B Hidalgo, Frederick Petty, Michael A Hertzberg, Thomas A Mellman, Phebe Tucker, Richard H Weisler, Sidney Zisook, S Chen, Erik Churchill, Jonathan R T DavidsonAbstract:Nefazodone, an antidepressant which blocks serotonin (5-HT) 2 receptors and 5-HT reuptake, was evaluated in the treatment of post-traumatic stress disorder (PTSD) in six open-label studies involving both civilians and combat veterans. Our objective was to report this available pooled data to characterize the response of this drug in PTSD. Specifically, we looked at response rates using three different criteria, the effect of Nefazodone on each PTSD cluster and individual symptoms and, lastly, variables that might predict response. One hundred and five outpatients with chronic PTSD were treated with Nefazodone titrated up to 600 mg/day, 92 of whom were entered in an intent to treat analysis. We used the percentage drop in score between baseline and endpoint on main scale as a common measure to evaluate outcome. The response criterion of a drop in score of at least 30%, 40% and 50% revealed response rates of 46, 36 and 26%, respectively. Nefazodone showed a broad spectrum of action on PTSD symptoms. This profile might make Nefazodone a useful drug to treat PTSD. Predictors of response include age, sex and trauma type. Double-blind, placebo-controlled clinical trials in PTSD are in progress to assess the utility of Nefazodone as a treatment in this disorder.
Gerald W. Vogel - One of the best experts on this subject based on the ideXlab platform.
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Comparative effects of Nefazodone and fluoxetine on sleep in outpatients with major depressive disorder
Biological psychiatry, 1998Co-Authors: A. John Rush, Gerald W. Vogel, Stephen Kaplita, Roseanne Armitage, J. Christian Gillin, Kimberly A. Yonkers, Andrew Winokur, Harvey Moldofsky, Jonathan B Fleming, Jacques MontplaisirAbstract:Abstract Background: Sleep disturbances are common in major depressive disorder. In previous open-label trials, Nefazodone improved sleep continuity and increased rapid eye movement (REM) sleep, while not affecting stage 3/4 sleep or REM latency; in contrast, fluoxetine suppressed REM sleep. This study compared the objective and subjective effects of Nefazodone and fluoxetine on sleep. Methods: This paper reports combined results of three identical, multisite, randomized, double-blind, 8-week, acute-phase trials comparing Nefazodone ( n = 64) with fluoxetine ( n = 61) in outpatients with nonpsychotic major depressive disorder and insomnia. Sleep electroencephalographic (EEG) recordings were gathered at baseline and weeks 2, 4, and 8. Clinical ratings were obtained at weeks 1–4, 6, and 8. Results: Nefazodone and fluoxetine were equally effective in reducing depressive symptoms; however, Nefazodone differentially and progressively increased (while fluoxetine reduced) sleep efficiency and reduced (while fluoxetine increased) the number of awakenings in a linear fashion over the 8-week trial. Fluoxetine, but not Nefazodone, prolonged REM latency and suppressed REM sleep. Nefazodone significantly increased total REM sleep time. Clinical evaluations of sleep quality were significantly improved with Nefazodone compared with fluoxetine. Conclusions: Nefazodone and fluoxetine were equally effective antidepressants. Nefazodone was associated with normal objective, and clinician- and patient-rated assessments of sleep when compared with fluoxetine. These differential sleep EEG effects are consstent with the notion that Nefazodone and fluoxetine may have somewhat different modes and spectra of action.
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Nefazodone and REM Sleep: How Do Antidepressant Drugs Decrease REM Sleep?
Sleep, 1998Co-Authors: Gerald W. Vogel, Jonathan Cohen, Deidre Mullis, Terry T. Kensler, Stephen KaplitaAbstract:In previous uncontrolled studies, Nefazodone, a new antidepressant drug, increased REM sleep or had no effect on REM sleep. We report a double-blind, placebo-controlled, parallel group study on effects of Nefazodone (N) on polysomnographic sleep variables in healthy human volunteers. Nefazodone was administered for 16 consecutive days, and nocturnal sleep, as well as multiple sleep latency test (MSLT), was monitored before, during, and after N administration. We found that N had no effect on any measured REM sleep variable including REM sleep duration, REM density, and nocturnal REM sleep distribution. Nefazodone also had no significant effect on nocturnal total sleep time or NREM variables, but increased daytime alertness measured by the MSLT. Since N is a potent serotonin reuptake blocker, the present findings that N had no effect on REM sleep cast doubt on the hypothesis that antidepressant drugs decrease REM sleep by increasing serotonergic neurotransmission. A review of other relevant work also casts doubt on this hypothesis.
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Effects Of Nefazodone On Sleep Architecture And Daytime Alertness
Neuropsychopharmacology, 1994Co-Authors: Gerald W. Vogel, Jonathan Cohen, Stephen Kaplita, Martha M Frescura, Ute Schwiderski, Terry T. KenslerAbstract:Nefazodone is a new antidepressant drug that is both a 5-HT2 antagonist and a serotonin reuptake inhibitor. It has been demonstrated to be safe and effective for the treatment of patients with major depression. This double-blind, randomized, parallel group study compared the effects of Nefazodone and placebo on sleep architecture and daytime alertness in 22 normal volunteers. Polysomnographic recordings were obtained in the sleep laboratory for each subject (11 per treatment group) during a 3-night placebo run-in period, 8 nights of a 2-week treatment period, and 2 nights of placebo washout. Nightly time in bed was controlled at 480 minutes for all subjects. Following the single-blind placebo run-in period, subjects were randomized to receive either Nefazodone or placebo. Nefazodone was dosed at 100 mg BID during the first treatment week and 200 mg BID during the second week. Daytime alertness was evaluated using the Multiple Sleep Latency Test (MSLT) before, during, and after treatment. Compared with placebo, Nefazodone did not disrupt normal sleep architecture and, unlike most other antidepressant drugs, it had no effect on REM sleep (time, density, or latency). Although Nefazodone is mildly sedating clinically, it had no overall effect on total sleep time (or sleep efficiency) or the number of awakenings. In addition, all other aspects of sleep architecture, including the proportion of slow wave (stage 3 and 4) sleep, were unchanged after two weeks of treatment. The MSLT showed no evidence that Nefazodone caused daytime sleepiness.
