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Re: News - Antidepressants Vindicated? linkadge

Posted by Larry Hoover on September 17, 2007, at 20:38:43

In reply to Re: News - Antidepressants Vindicated?, posted by linkadge on September 16, 2007, at 21:28:51

> >Why do you want to have more long term studies >of venlafaxine or any other ADs when facts have >establish according to you that placebo work as >well as antidepressant? Why should people waste >money,time and their energy by conducting more >long term trials when it is already known that >venlafaxine is no better then placebo?
> The more clinical trials the better. I am not against the possability that certain drugs may vindicate themselves, or that certain drugs will one day provide a more definively clear and consistent superiority to placebo.
> Linkadge

Here are two recent reports about one study, PREVENT. One is an analysis of relapse rates on venlafaxine vs. fluoxetine, the other venlafaxine vs. placebo.

Biol Psychiatry. 2007 Sep 6; [Epub ahead of print]
The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study: Outcomes from the Acute and Continuation Phases.
Keller MB, Trivedi MH, Thase ME, Shelton RC, Kornstein SG, Nemeroff CB, Friedman ES, Gelenberg AJ, Kocsis JH, Dunner DL, Dunlop BW, Hirschfeld RM, Rothschild AJ, Ferguson JM, Schatzberg AF, Zajecka JM, Pedersen R, Yan B, Ahmed S, Schmidt M, Ninan PT.
Brown University Providence, Rhode Island.

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.

J Clin Psychiatry. 2007 Jul;68(7):1014-23.
Prevention of recurrent episodes of depression with venlafaxine ER in a 1-year maintenance phase from the PREVENT Study.
Kocsis JH, Thase ME, Trivedi MH, Shelton RC, Kornstein SG, Nemeroff CB, Friedman ES, Gelenberg AJ, Dunner DL, Hirschfeld RM, Rothschild AJ, Ferguson JM, Schatzberg AF, Zajecka JM, Pedersen RD, Yan B, Ahmed S, Musgnung J, Ninan PT, Keller MB.
Department of Psychiatry, Weill Cornell Medical College, New York, NY 10012, USA.

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: identifier NCT00046020.




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