Venlafaxine

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Michael E Thase - One of the best experts on this subject based on the ideXlab platform.

  • the prevention of recurrent episodes of depression with Venlafaxine for two years prevent study outcomes from the acute and continuation phases
    Biological Psychiatry, 2007
    Co-Authors: Martin B Keller, Michael E Thase, James H Kocsis, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner
    Abstract:

    Background We evaluated the comparative efficacy and safety of Venlafaxine extended release (ER) and fluoxetine in the acute and continuation phases of treatment. Methods In this multicenter, double-blind study, outpatients with recurrent unipolar major depression were randomly assigned to receive Venlafaxine ER (75–300 mg/day; n = 821) or fluoxetine (20–60 mg/day; n = 275). After a 10-week acute treatment phase, responders entered a 6-month continuation phase of ongoing therapy with double-blind Venlafaxine ER ( n = 530) or fluoxetine ( n = 185). In the acute phase, the primary outcome was response, defined as a 17-item Hamilton Depression Rating Scale (HDRS) score ≤12 or ≥50% decrease from baseline; the secondary outcome was remission, defined as a HDRS score ≤7. In the continuation phase, the primary outcome was the proportion of patients who sustained response or remission. Secondary measures included time to onset of sustained response or remission (i.e., meeting criteria at two or more consecutive visits), relapse rates, and quality-of-life measures. Results At the acute treatment phase end point, response rates were 79% for both Venlafaxine ER and fluoxetine; remission rates were 49% and 50% for Venlafaxine ER and fluoxetine, respectively. In the continuation phase, response rates were 90% and 92%, and remission rates were 72% and 69% for Venlafaxine ER and fluoxetine, respectively. Rates of sustained remission at the end of the continuation phase were 52% and 58% for Venlafaxine ER and fluoxetine, respectively. Conclusion Venlafaxine ER and fluoxetine were comparably effective during both acute and continuation phase therapy.

  • the prevention of recurrent episodes of depression with Venlafaxine for two years prevent study outcomes from the 2 year and combined maintenance phases
    The Journal of Clinical Psychiatry, 2007
    Co-Authors: Martin B Keller, Michael E Thase, James H Kocsis, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner
    Abstract:

    OBJECTIVE: To report second-year results from the 2-year maintenance phase of a long-term study to evaluate the efficacy and safety of Venlafaxine extended release (ER) in preventing recurrence of depression. METHOD: Outpatients with recurrent unipolar depression (DSM-IV criteria; N = 1096) were randomly assigned in a 3:1 ratio to 10 weeks of treatment with Venlafaxine ER or fluoxetine. Responders (17-item Hamilton Rating Scale for Depression [HAM-D(17)] total score or= 50% decrease from baseline) entered a 6-month, double-blind continuation phase on the same medication. Continuation-phase responders were enrolled into maintenance treatment consisting of 2 consecutive 12-month phases. At the start of each maintenance phase, Venlafaxine ER responders were randomly assigned to receive double-blind treatment with Venlafaxine ER or placebo, and fluoxetine responders were continued for each period. The second 12-month maintenance phase compared the time to recurrence of depression with Venlafaxine ER (75 to 300 mg/day) versus placebo as the primary efficacy measure. The primary definition of recurrence was a HAM-D(17) total score > 12 and < 50% reduction from baseline (acute phase) at 2 consecutive visits or at the last valid visit prior to discontinuation. The time to recurrence was evaluated using Kaplan-Meier methods and compared between the Venlafaxine ER and placebo groups using log-rank tests. Secondary outcome measures included rates of response and remission (defined as HAM-D(17) Venlafaxine ER (N = 43) and placebo (N = 40) groups were 8.0% (95% CI = 0.0 to 16.8) and 44.8% (95% CI = 27.6 to 62.0), respectively (p < .001). At month 12, using last-observation-carried-forward analysis, the rate of response or remission was significantly higher in the Venlafaxine ER group (93%) than in the placebo group (63%; p = .002). Overall discontinuation rates were 28% and 63% in the Venlafaxine ER and placebo groups, respectively. Adverse events were the primary reason for discontinuation for 1 patient (2%) in the venlafax-ine ER group and 4 (10%) in the placebo group. An analysis of the combined maintenance phases, which compared the risk of recurrence over 24 months for patients assigned to Venlafaxine ER (N = 129) or placebo (N = 129) for the first maintenance phase, showed a significantly greater cumulative probability of recurrence through 24 months for the placebo group (47.3% [95% CI = 36.4 to 58.2]) than for the Venlafaxine ER group (28.5% [95% CI = 18.3 to 38.7]; p = .005). CONCLUSION: In this study, an additional 12 months of maintenance therapy with Venlafaxine ER was effective in preventing recurrence of depression in patients who had been responders to Venlafaxine ER after acute (10 weeks), continuation (6 months), and initial maintenance (12 months) therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00046020 (http://www.clinicaltrials.gov).

  • prevention of recurrent episodes of depression with Venlafaxine er in a 1 year maintenance phase from the prevent study
    The Journal of Clinical Psychiatry, 2007
    Co-Authors: James H Kocsis, Michael E Thase, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner, Robert M A Hirschfeld
    Abstract:

    OBJECTIVES: To test the long-term efficacy and safety of Venlafaxine extended-release (ER) in preventing recurrence in patients with major depression. METHOD: This multiple-phase study, entitled "Prevention of Recurrent Episodes of Depression With Venlafaxine for Two Years" (PREVENT), was conducted from December 2000 through July 2005 in patients with recurrent unipolar depression (DSM-IV) who were initially randomly assigned to double-blind treatment with Venlafaxine ER (75 mg/day to 300 mg/day) or fluoxetine (20 mg/day to 60 mg/day) for 10 weeks of acute treatment. Responders then received 6 months of continuation treatment. Those who remained responders were then enrolled into a 12-month maintenance period. Venlafaxine ER responders were randomly assigned to receive double-blind treatment with Venlafaxine ER or placebo. Fluoxetine responders were not randomly assigned but continued taking fluoxetine in order to maintain the blind during the maintenance study. Time to recurrence of depression (17-item Hamilton Rating Scale for Depression total score > 12 and < 50% reduction from acute phase baseline) with Venlafaxine ER versus that of placebo were compared. RESULTS: The efficacy evaluable sample consisted of 129 patients in each group. The mean daily dose of Venlafaxine ER was 224.7 mg (SD = 66.7). The cumulative probability of recurrence through 12 months, based on the primary definition, was 23.1% (95% CI = 15.3 to 30.9) for Venlafaxine ER and 42.0% (95% CI = 31.8 to 52.2) for placebo (p = .005, log-rank test). CONCLUSION: Patients who had been successfully treated with Venlafaxine ER during acute and continuation therapy were significantly less likely to experience recurrence with Venlafaxine ER than with placebo over a 12-month maintenance treatment period. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00046020.

  • remission rates during treatment with Venlafaxine or selective serotonin reuptake inhibitors
    British Journal of Psychiatry, 2001
    Co-Authors: Michael E Thase, Richard A Entsuah, Richard L. Rudolph
    Abstract:

    Background It had been suggested that the antidepressant Venlafaxine, which inhibits reuptake of both serotonin and (at higher doses) noradrenaline, may result in better outcomes than treatment with selective serotonin reuptake inhibitors (SSRIs). Aims To compare remission rates during treatment with SSRIs or Venlafaxine. Method Data from eight comparable randomised, double-blind studies of major depressive disorder were pooled to compare remission rates (Hamilton Rating Scale for Depression score ≤7) during treatment with Venlafaxine ( n =851), SSRIs (fluoxetine, paroxetine, fluvoxamine; n =748) or placebo (four studies; n =446). Results Remission rates were: Venlafaxine, 45% (382/851); SSRIs, 35% (260/748); placebo, 25% (110/446) ( P < 0.001; odds ratio for remission is 1.50 (1.3-1.9), favouring Venlafaxine v . SSRIs). The difference between Venlafaxine and the SSRIs was significant at week 2, whereas the difference between SSRIs and placebo reached significance at week 4. Results were not dependent on any one study or the definition of remission. Conclusions Remission rates were significantly higher with Venlafaxine than with an SSRI.

  • effects of Venlafaxine on blood pressure a meta analysis of original data from 3744 depressed patients
    The Journal of Clinical Psychiatry, 1998
    Co-Authors: Michael E Thase
    Abstract:

    Background Venlafaxine hydrochloride, a structurally novel antidepressant, is also the first nontricyclic serotonin/norepinephrine reuptake inhibitor. Although Venlafaxine has an overall side effect and safety profile that is comparable to other newer antidepressants, it can cause both transient and sustained elevations of supine diastolic blood pressure (SDBP), probably the result of noradrenergic potentiation. Method Presented here is a meta-analysis of original data on blood pressure, using both random effects and a multivariate survival analyses. The sample consisted of 3744 patients with major depression who were studied in controlled clinical trials comparing Venlafaxine with imipramine and/or placebo. Patients were treated for 6 weeks of acute phase therapy; some responders received up to 1 year of continuation phase therapy. Results Venlafaxine and imipramine were associated with small, but statistically significant, increases in SDBP during acute phase therapy. When compared with imipramine and placebo, Venlafaxine was also associated with a greater proportion of persistent elevations of SDBP during continuation therapy. The effect of Venlafaxine was highly dose dependent, and the incidence of elevated SDBP was statistically and clinically significant only at dosages above 300 mg/day. Venlafaxine did not adversely affect the control of blood pressure for patients with preexisting high blood pressure or elevated baseline values. Conclusion Venlafaxine has a dose-dependent effect on SDBP that is clinically significant at high dosages. Concern about blood pressure effects should not deter first-line use of this effective antidepressant, although more extensive studies of patients with cardiovascular diseases are still necessary.

David L Dunner - One of the best experts on this subject based on the ideXlab platform.

  • the prevention of recurrent episodes of depression with Venlafaxine for two years prevent study outcomes from the acute and continuation phases
    Biological Psychiatry, 2007
    Co-Authors: Martin B Keller, Michael E Thase, James H Kocsis, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner
    Abstract:

    Background We evaluated the comparative efficacy and safety of Venlafaxine extended release (ER) and fluoxetine in the acute and continuation phases of treatment. Methods In this multicenter, double-blind study, outpatients with recurrent unipolar major depression were randomly assigned to receive Venlafaxine ER (75–300 mg/day; n = 821) or fluoxetine (20–60 mg/day; n = 275). After a 10-week acute treatment phase, responders entered a 6-month continuation phase of ongoing therapy with double-blind Venlafaxine ER ( n = 530) or fluoxetine ( n = 185). In the acute phase, the primary outcome was response, defined as a 17-item Hamilton Depression Rating Scale (HDRS) score ≤12 or ≥50% decrease from baseline; the secondary outcome was remission, defined as a HDRS score ≤7. In the continuation phase, the primary outcome was the proportion of patients who sustained response or remission. Secondary measures included time to onset of sustained response or remission (i.e., meeting criteria at two or more consecutive visits), relapse rates, and quality-of-life measures. Results At the acute treatment phase end point, response rates were 79% for both Venlafaxine ER and fluoxetine; remission rates were 49% and 50% for Venlafaxine ER and fluoxetine, respectively. In the continuation phase, response rates were 90% and 92%, and remission rates were 72% and 69% for Venlafaxine ER and fluoxetine, respectively. Rates of sustained remission at the end of the continuation phase were 52% and 58% for Venlafaxine ER and fluoxetine, respectively. Conclusion Venlafaxine ER and fluoxetine were comparably effective during both acute and continuation phase therapy.

  • the prevention of recurrent episodes of depression with Venlafaxine for two years prevent study outcomes from the 2 year and combined maintenance phases
    The Journal of Clinical Psychiatry, 2007
    Co-Authors: Martin B Keller, Michael E Thase, James H Kocsis, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner
    Abstract:

    OBJECTIVE: To report second-year results from the 2-year maintenance phase of a long-term study to evaluate the efficacy and safety of Venlafaxine extended release (ER) in preventing recurrence of depression. METHOD: Outpatients with recurrent unipolar depression (DSM-IV criteria; N = 1096) were randomly assigned in a 3:1 ratio to 10 weeks of treatment with Venlafaxine ER or fluoxetine. Responders (17-item Hamilton Rating Scale for Depression [HAM-D(17)] total score or= 50% decrease from baseline) entered a 6-month, double-blind continuation phase on the same medication. Continuation-phase responders were enrolled into maintenance treatment consisting of 2 consecutive 12-month phases. At the start of each maintenance phase, Venlafaxine ER responders were randomly assigned to receive double-blind treatment with Venlafaxine ER or placebo, and fluoxetine responders were continued for each period. The second 12-month maintenance phase compared the time to recurrence of depression with Venlafaxine ER (75 to 300 mg/day) versus placebo as the primary efficacy measure. The primary definition of recurrence was a HAM-D(17) total score > 12 and < 50% reduction from baseline (acute phase) at 2 consecutive visits or at the last valid visit prior to discontinuation. The time to recurrence was evaluated using Kaplan-Meier methods and compared between the Venlafaxine ER and placebo groups using log-rank tests. Secondary outcome measures included rates of response and remission (defined as HAM-D(17) Venlafaxine ER (N = 43) and placebo (N = 40) groups were 8.0% (95% CI = 0.0 to 16.8) and 44.8% (95% CI = 27.6 to 62.0), respectively (p < .001). At month 12, using last-observation-carried-forward analysis, the rate of response or remission was significantly higher in the Venlafaxine ER group (93%) than in the placebo group (63%; p = .002). Overall discontinuation rates were 28% and 63% in the Venlafaxine ER and placebo groups, respectively. Adverse events were the primary reason for discontinuation for 1 patient (2%) in the venlafax-ine ER group and 4 (10%) in the placebo group. An analysis of the combined maintenance phases, which compared the risk of recurrence over 24 months for patients assigned to Venlafaxine ER (N = 129) or placebo (N = 129) for the first maintenance phase, showed a significantly greater cumulative probability of recurrence through 24 months for the placebo group (47.3% [95% CI = 36.4 to 58.2]) than for the Venlafaxine ER group (28.5% [95% CI = 18.3 to 38.7]; p = .005). CONCLUSION: In this study, an additional 12 months of maintenance therapy with Venlafaxine ER was effective in preventing recurrence of depression in patients who had been responders to Venlafaxine ER after acute (10 weeks), continuation (6 months), and initial maintenance (12 months) therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00046020 (http://www.clinicaltrials.gov).

  • prevention of recurrent episodes of depression with Venlafaxine er in a 1 year maintenance phase from the prevent study
    The Journal of Clinical Psychiatry, 2007
    Co-Authors: James H Kocsis, Michael E Thase, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner, Robert M A Hirschfeld
    Abstract:

    OBJECTIVES: To test the long-term efficacy and safety of Venlafaxine extended-release (ER) in preventing recurrence in patients with major depression. METHOD: This multiple-phase study, entitled "Prevention of Recurrent Episodes of Depression With Venlafaxine for Two Years" (PREVENT), was conducted from December 2000 through July 2005 in patients with recurrent unipolar depression (DSM-IV) who were initially randomly assigned to double-blind treatment with Venlafaxine ER (75 mg/day to 300 mg/day) or fluoxetine (20 mg/day to 60 mg/day) for 10 weeks of acute treatment. Responders then received 6 months of continuation treatment. Those who remained responders were then enrolled into a 12-month maintenance period. Venlafaxine ER responders were randomly assigned to receive double-blind treatment with Venlafaxine ER or placebo. Fluoxetine responders were not randomly assigned but continued taking fluoxetine in order to maintain the blind during the maintenance study. Time to recurrence of depression (17-item Hamilton Rating Scale for Depression total score > 12 and < 50% reduction from acute phase baseline) with Venlafaxine ER versus that of placebo were compared. RESULTS: The efficacy evaluable sample consisted of 129 patients in each group. The mean daily dose of Venlafaxine ER was 224.7 mg (SD = 66.7). The cumulative probability of recurrence through 12 months, based on the primary definition, was 23.1% (95% CI = 15.3 to 30.9) for Venlafaxine ER and 42.0% (95% CI = 31.8 to 52.2) for placebo (p = .005, log-rank test). CONCLUSION: Patients who had been successfully treated with Venlafaxine ER during acute and continuation therapy were significantly less likely to experience recurrence with Venlafaxine ER than with placebo over a 12-month maintenance treatment period. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00046020.

James H Kocsis - One of the best experts on this subject based on the ideXlab platform.

  • the prevention of recurrent episodes of depression with Venlafaxine for two years prevent study outcomes from the acute and continuation phases
    Biological Psychiatry, 2007
    Co-Authors: Martin B Keller, Michael E Thase, James H Kocsis, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner
    Abstract:

    Background We evaluated the comparative efficacy and safety of Venlafaxine extended release (ER) and fluoxetine in the acute and continuation phases of treatment. Methods In this multicenter, double-blind study, outpatients with recurrent unipolar major depression were randomly assigned to receive Venlafaxine ER (75–300 mg/day; n = 821) or fluoxetine (20–60 mg/day; n = 275). After a 10-week acute treatment phase, responders entered a 6-month continuation phase of ongoing therapy with double-blind Venlafaxine ER ( n = 530) or fluoxetine ( n = 185). In the acute phase, the primary outcome was response, defined as a 17-item Hamilton Depression Rating Scale (HDRS) score ≤12 or ≥50% decrease from baseline; the secondary outcome was remission, defined as a HDRS score ≤7. In the continuation phase, the primary outcome was the proportion of patients who sustained response or remission. Secondary measures included time to onset of sustained response or remission (i.e., meeting criteria at two or more consecutive visits), relapse rates, and quality-of-life measures. Results At the acute treatment phase end point, response rates were 79% for both Venlafaxine ER and fluoxetine; remission rates were 49% and 50% for Venlafaxine ER and fluoxetine, respectively. In the continuation phase, response rates were 90% and 92%, and remission rates were 72% and 69% for Venlafaxine ER and fluoxetine, respectively. Rates of sustained remission at the end of the continuation phase were 52% and 58% for Venlafaxine ER and fluoxetine, respectively. Conclusion Venlafaxine ER and fluoxetine were comparably effective during both acute and continuation phase therapy.

  • the prevention of recurrent episodes of depression with Venlafaxine for two years prevent study outcomes from the 2 year and combined maintenance phases
    The Journal of Clinical Psychiatry, 2007
    Co-Authors: Martin B Keller, Michael E Thase, James H Kocsis, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner
    Abstract:

    OBJECTIVE: To report second-year results from the 2-year maintenance phase of a long-term study to evaluate the efficacy and safety of Venlafaxine extended release (ER) in preventing recurrence of depression. METHOD: Outpatients with recurrent unipolar depression (DSM-IV criteria; N = 1096) were randomly assigned in a 3:1 ratio to 10 weeks of treatment with Venlafaxine ER or fluoxetine. Responders (17-item Hamilton Rating Scale for Depression [HAM-D(17)] total score or= 50% decrease from baseline) entered a 6-month, double-blind continuation phase on the same medication. Continuation-phase responders were enrolled into maintenance treatment consisting of 2 consecutive 12-month phases. At the start of each maintenance phase, Venlafaxine ER responders were randomly assigned to receive double-blind treatment with Venlafaxine ER or placebo, and fluoxetine responders were continued for each period. The second 12-month maintenance phase compared the time to recurrence of depression with Venlafaxine ER (75 to 300 mg/day) versus placebo as the primary efficacy measure. The primary definition of recurrence was a HAM-D(17) total score > 12 and < 50% reduction from baseline (acute phase) at 2 consecutive visits or at the last valid visit prior to discontinuation. The time to recurrence was evaluated using Kaplan-Meier methods and compared between the Venlafaxine ER and placebo groups using log-rank tests. Secondary outcome measures included rates of response and remission (defined as HAM-D(17) Venlafaxine ER (N = 43) and placebo (N = 40) groups were 8.0% (95% CI = 0.0 to 16.8) and 44.8% (95% CI = 27.6 to 62.0), respectively (p < .001). At month 12, using last-observation-carried-forward analysis, the rate of response or remission was significantly higher in the Venlafaxine ER group (93%) than in the placebo group (63%; p = .002). Overall discontinuation rates were 28% and 63% in the Venlafaxine ER and placebo groups, respectively. Adverse events were the primary reason for discontinuation for 1 patient (2%) in the venlafax-ine ER group and 4 (10%) in the placebo group. An analysis of the combined maintenance phases, which compared the risk of recurrence over 24 months for patients assigned to Venlafaxine ER (N = 129) or placebo (N = 129) for the first maintenance phase, showed a significantly greater cumulative probability of recurrence through 24 months for the placebo group (47.3% [95% CI = 36.4 to 58.2]) than for the Venlafaxine ER group (28.5% [95% CI = 18.3 to 38.7]; p = .005). CONCLUSION: In this study, an additional 12 months of maintenance therapy with Venlafaxine ER was effective in preventing recurrence of depression in patients who had been responders to Venlafaxine ER after acute (10 weeks), continuation (6 months), and initial maintenance (12 months) therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00046020 (http://www.clinicaltrials.gov).

  • prevention of recurrent episodes of depression with Venlafaxine er in a 1 year maintenance phase from the prevent study
    The Journal of Clinical Psychiatry, 2007
    Co-Authors: James H Kocsis, Michael E Thase, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner, Robert M A Hirschfeld
    Abstract:

    OBJECTIVES: To test the long-term efficacy and safety of Venlafaxine extended-release (ER) in preventing recurrence in patients with major depression. METHOD: This multiple-phase study, entitled "Prevention of Recurrent Episodes of Depression With Venlafaxine for Two Years" (PREVENT), was conducted from December 2000 through July 2005 in patients with recurrent unipolar depression (DSM-IV) who were initially randomly assigned to double-blind treatment with Venlafaxine ER (75 mg/day to 300 mg/day) or fluoxetine (20 mg/day to 60 mg/day) for 10 weeks of acute treatment. Responders then received 6 months of continuation treatment. Those who remained responders were then enrolled into a 12-month maintenance period. Venlafaxine ER responders were randomly assigned to receive double-blind treatment with Venlafaxine ER or placebo. Fluoxetine responders were not randomly assigned but continued taking fluoxetine in order to maintain the blind during the maintenance study. Time to recurrence of depression (17-item Hamilton Rating Scale for Depression total score > 12 and < 50% reduction from acute phase baseline) with Venlafaxine ER versus that of placebo were compared. RESULTS: The efficacy evaluable sample consisted of 129 patients in each group. The mean daily dose of Venlafaxine ER was 224.7 mg (SD = 66.7). The cumulative probability of recurrence through 12 months, based on the primary definition, was 23.1% (95% CI = 15.3 to 30.9) for Venlafaxine ER and 42.0% (95% CI = 31.8 to 52.2) for placebo (p = .005, log-rank test). CONCLUSION: Patients who had been successfully treated with Venlafaxine ER during acute and continuation therapy were significantly less likely to experience recurrence with Venlafaxine ER than with placebo over a 12-month maintenance treatment period. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00046020.

G M G I Ramaekers - One of the best experts on this subject based on the ideXlab platform.

  • treatment of unipolar psychotic depression a randomized double blind study comparing imipramine Venlafaxine and Venlafaxine plus quetiapine
    Acta Psychiatrica Scandinavica, 2010
    Co-Authors: Jaap Wijkstra, Jan A. Bruijn, Tom K. Birkenhäger, Huibert Burger, W W Van Den Broek, Joost G E Janzing, Marco P M Boks, M L M Van Der Loos, Leonie M T Breteler, G M G I Ramaekers
    Abstract:

    OBJECTIVE: It remains unclear whether unipolar psychotic depression should be treated with an antidepressant and an antipsychotic or with an antidepressant alone. METHOD: In a multi-center RCT, 122 patients (18-65 years) with DSM-IV-TR psychotic major depression and HAM-D-17 > or = 18 were randomized to 7 weeks imipramine (plasma-levels 200-300 microg/l), Venlafaxine (375 mg/day) or Venlafaxine-quetiapine (375 mg/day, 600 mg/day). Primary outcome was response on HAM-D-17. Secondary outcomes were response on CGI and remission (HAM-D-17). RESULTS: Venlafaxine-quetiapine was more effective than Venlafaxine with no significant differences between Venlafaxine-quetiapine and imipramine, or between imipramine and Venlafaxine. Secondary outcomes followed the same pattern. CONCLUSION: That unipolar psychotic depression should be treated with a combination of an antidepressant and an antipsychotic and not with an antidepressant alone, can be considered evidence based with regard to Venlafaxine-quetiapine vs. Venlafaxine monotherapy. Whether this is also the case for imipramine monotherapy is likely, but cannot be concluded from the data.

  • Treatment of unipolar psychotic depression: a randomized, double‐blind study comparing imipramine, Venlafaxine, and Venlafaxine plus quetiapine
    Acta Psychiatrica Scandinavica, 2009
    Co-Authors: Jaap Wijkstra, Jan A. Bruijn, Tom K. Birkenhäger, Huibert Burger, W W Van Den Broek, Joost G E Janzing, Marco P M Boks, M L M Van Der Loos, Leonie M T Breteler, G M G I Ramaekers
    Abstract:

    OBJECTIVE: It remains unclear whether unipolar psychotic depression should be treated with an antidepressant and an antipsychotic or with an antidepressant alone. METHOD: In a multi-center RCT, 122 patients (18-65 years) with DSM-IV-TR psychotic major depression and HAM-D-17 > or = 18 were randomized to 7 weeks imipramine (plasma-levels 200-300 microg/l), Venlafaxine (375 mg/day) or Venlafaxine-quetiapine (375 mg/day, 600 mg/day). Primary outcome was response on HAM-D-17. Secondary outcomes were response on CGI and remission (HAM-D-17). RESULTS: Venlafaxine-quetiapine was more effective than Venlafaxine with no significant differences between Venlafaxine-quetiapine and imipramine, or between imipramine and Venlafaxine. Secondary outcomes followed the same pattern. CONCLUSION: That unipolar psychotic depression should be treated with a combination of an antidepressant and an antipsychotic and not with an antidepressant alone, can be considered evidence based with regard to Venlafaxine-quetiapine vs. Venlafaxine monotherapy. Whether this is also the case for imipramine monotherapy is likely, but cannot be concluded from the data.

Richard C Shelton - One of the best experts on this subject based on the ideXlab platform.

  • the prevention of recurrent episodes of depression with Venlafaxine for two years prevent study outcomes from the acute and continuation phases
    Biological Psychiatry, 2007
    Co-Authors: Martin B Keller, Michael E Thase, James H Kocsis, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner
    Abstract:

    Background We evaluated the comparative efficacy and safety of Venlafaxine extended release (ER) and fluoxetine in the acute and continuation phases of treatment. Methods In this multicenter, double-blind study, outpatients with recurrent unipolar major depression were randomly assigned to receive Venlafaxine ER (75–300 mg/day; n = 821) or fluoxetine (20–60 mg/day; n = 275). After a 10-week acute treatment phase, responders entered a 6-month continuation phase of ongoing therapy with double-blind Venlafaxine ER ( n = 530) or fluoxetine ( n = 185). In the acute phase, the primary outcome was response, defined as a 17-item Hamilton Depression Rating Scale (HDRS) score ≤12 or ≥50% decrease from baseline; the secondary outcome was remission, defined as a HDRS score ≤7. In the continuation phase, the primary outcome was the proportion of patients who sustained response or remission. Secondary measures included time to onset of sustained response or remission (i.e., meeting criteria at two or more consecutive visits), relapse rates, and quality-of-life measures. Results At the acute treatment phase end point, response rates were 79% for both Venlafaxine ER and fluoxetine; remission rates were 49% and 50% for Venlafaxine ER and fluoxetine, respectively. In the continuation phase, response rates were 90% and 92%, and remission rates were 72% and 69% for Venlafaxine ER and fluoxetine, respectively. Rates of sustained remission at the end of the continuation phase were 52% and 58% for Venlafaxine ER and fluoxetine, respectively. Conclusion Venlafaxine ER and fluoxetine were comparably effective during both acute and continuation phase therapy.

  • the prevention of recurrent episodes of depression with Venlafaxine for two years prevent study outcomes from the 2 year and combined maintenance phases
    The Journal of Clinical Psychiatry, 2007
    Co-Authors: Martin B Keller, Michael E Thase, James H Kocsis, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner
    Abstract:

    OBJECTIVE: To report second-year results from the 2-year maintenance phase of a long-term study to evaluate the efficacy and safety of Venlafaxine extended release (ER) in preventing recurrence of depression. METHOD: Outpatients with recurrent unipolar depression (DSM-IV criteria; N = 1096) were randomly assigned in a 3:1 ratio to 10 weeks of treatment with Venlafaxine ER or fluoxetine. Responders (17-item Hamilton Rating Scale for Depression [HAM-D(17)] total score or= 50% decrease from baseline) entered a 6-month, double-blind continuation phase on the same medication. Continuation-phase responders were enrolled into maintenance treatment consisting of 2 consecutive 12-month phases. At the start of each maintenance phase, Venlafaxine ER responders were randomly assigned to receive double-blind treatment with Venlafaxine ER or placebo, and fluoxetine responders were continued for each period. The second 12-month maintenance phase compared the time to recurrence of depression with Venlafaxine ER (75 to 300 mg/day) versus placebo as the primary efficacy measure. The primary definition of recurrence was a HAM-D(17) total score > 12 and < 50% reduction from baseline (acute phase) at 2 consecutive visits or at the last valid visit prior to discontinuation. The time to recurrence was evaluated using Kaplan-Meier methods and compared between the Venlafaxine ER and placebo groups using log-rank tests. Secondary outcome measures included rates of response and remission (defined as HAM-D(17) Venlafaxine ER (N = 43) and placebo (N = 40) groups were 8.0% (95% CI = 0.0 to 16.8) and 44.8% (95% CI = 27.6 to 62.0), respectively (p < .001). At month 12, using last-observation-carried-forward analysis, the rate of response or remission was significantly higher in the Venlafaxine ER group (93%) than in the placebo group (63%; p = .002). Overall discontinuation rates were 28% and 63% in the Venlafaxine ER and placebo groups, respectively. Adverse events were the primary reason for discontinuation for 1 patient (2%) in the venlafax-ine ER group and 4 (10%) in the placebo group. An analysis of the combined maintenance phases, which compared the risk of recurrence over 24 months for patients assigned to Venlafaxine ER (N = 129) or placebo (N = 129) for the first maintenance phase, showed a significantly greater cumulative probability of recurrence through 24 months for the placebo group (47.3% [95% CI = 36.4 to 58.2]) than for the Venlafaxine ER group (28.5% [95% CI = 18.3 to 38.7]; p = .005). CONCLUSION: In this study, an additional 12 months of maintenance therapy with Venlafaxine ER was effective in preventing recurrence of depression in patients who had been responders to Venlafaxine ER after acute (10 weeks), continuation (6 months), and initial maintenance (12 months) therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00046020 (http://www.clinicaltrials.gov).

  • prevention of recurrent episodes of depression with Venlafaxine er in a 1 year maintenance phase from the prevent study
    The Journal of Clinical Psychiatry, 2007
    Co-Authors: James H Kocsis, Michael E Thase, Madhukar H Trivedi, Richard C Shelton, Susan G Kornstein, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, David L Dunner, Robert M A Hirschfeld
    Abstract:

    OBJECTIVES: To test the long-term efficacy and safety of Venlafaxine extended-release (ER) in preventing recurrence in patients with major depression. METHOD: This multiple-phase study, entitled "Prevention of Recurrent Episodes of Depression With Venlafaxine for Two Years" (PREVENT), was conducted from December 2000 through July 2005 in patients with recurrent unipolar depression (DSM-IV) who were initially randomly assigned to double-blind treatment with Venlafaxine ER (75 mg/day to 300 mg/day) or fluoxetine (20 mg/day to 60 mg/day) for 10 weeks of acute treatment. Responders then received 6 months of continuation treatment. Those who remained responders were then enrolled into a 12-month maintenance period. Venlafaxine ER responders were randomly assigned to receive double-blind treatment with Venlafaxine ER or placebo. Fluoxetine responders were not randomly assigned but continued taking fluoxetine in order to maintain the blind during the maintenance study. Time to recurrence of depression (17-item Hamilton Rating Scale for Depression total score > 12 and < 50% reduction from acute phase baseline) with Venlafaxine ER versus that of placebo were compared. RESULTS: The efficacy evaluable sample consisted of 129 patients in each group. The mean daily dose of Venlafaxine ER was 224.7 mg (SD = 66.7). The cumulative probability of recurrence through 12 months, based on the primary definition, was 23.1% (95% CI = 15.3 to 30.9) for Venlafaxine ER and 42.0% (95% CI = 31.8 to 52.2) for placebo (p = .005, log-rank test). CONCLUSION: Patients who had been successfully treated with Venlafaxine ER during acute and continuation therapy were significantly less likely to experience recurrence with Venlafaxine ER than with placebo over a 12-month maintenance treatment period. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00046020.