Hostname: page-component-cd9895bd7-lnqnp Total loading time: 0 Render date: 2024-12-23T16:14:31.290Z Has data issue: false hasContentIssue false

Beyond Remission: Rationale and Design of the Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study

Published online by Cambridge University Press:  07 November 2014

Abstract

Recurrent major depressive disorder (MDD) is a common and disabling illness, but few studies have addressed long-term antidepressant treatment of recurrent MDD (ie, beyond 1 year of maintenance therapy) or compared the efficacy and safety of different antidepressant classes in this population. This article describes the rationale and design of a unique multi-phase trial in patients with recurrent MDD. The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) study is a large double-blind, randomized, multi-center trial designed to assess the long-term efficacy of venlafaxine extended release (ER) in the prevention of depressive recurrence. Approximately 1,100 adult outpatients with MDD and a history of ≥3 lifetime episodes (with at least two occurring in the past 5 years) were randomized to 10 weeks of acute-phase treatment with either venlafaxine ER 75–300 mg/day or fluoxetine 20–60 mg/day, followed by 6 months of continuation-phase treatment for patients experiencing a satisfactory therapeutic response or remission during the acute phase. Responders and remitters to continuation phase treatment were then entered into a 2-year maintenance phase study, in which those receiving venlafaxine ER were re-randomized to either venlafaxine ER or placebo at the start of two 12-month maintenance periods. Those taking fluoxetine during the acute and continuation phases continued to receive double-blind treatment with fluoxetine. This study will address several unanswered questions about the long-term treatment of recurrent MDD, such as whether extended maintenance treatment (ie, up to 2 years) lessens the risk for developing future depressive episodes; whether fluoxetine and venlafaxine ER are effective for both short- and long-term treatment of MDD; whether rates of tachyphylaxis differ between anti- depressant classes; and whether the likelihood of depressive recurrence differs according to the time point when treatment is discontinued.

Type
Supplement
Copyright
Copyright © Cambridge University Press 2006

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Kupfer, DJ. Long-term treatment of depression. J Clin Psychiatry. 1991;52(suppl):2834.Google ScholarPubMed
2.Practice Guideline for the Treatment of Patients with Major Depressive Disorder. 2nd ed. Arlington, VA: American Psychiatric Association; 2000;vii87.Google Scholar
3.Judd, LL, Paulus, MJ, Schettler, PJ, et al.Does incomplete recovery from first lifetime major depressive episode herald a chronic course of illness? Am J Psychiatry. 2000;157:15011504.CrossRefGoogle Scholar
4.Mueller, TI, Leon, AC, Keller, MB, et al.Recurrence after recovery from major depressive disorder during 15 years of observational follow-up. Am J Psychiatry. 1999;156:10001006.CrossRefGoogle ScholarPubMed
5.Frank, E, Kupfer, DJ, Perel, JM, et al.Three-year outeomes for maintenance therapies in recurrent depression. Arch Gen Psychiatry. 1990;47:10931099.CrossRefGoogle ScholarPubMed
6.Hollon, SD, Shelton, RC, Wisniewski, S, et al.Presenting characteristics of depressed outpatients as a function of recurrence: Preliminary findings from the STAR*D clinical trial. J Psychiatr Res. 2006;40:5969.CrossRefGoogle ScholarPubMed
7.Montgomery, SA, Entsuah, R, Hackett, D, Kunz, NR, Rudolph, RL. Venlafaxine versus placebo in the preventive treatment of recurrent major depression. J Clin Psychiatry. 2004;65:328336.CrossRefGoogle ScholarPubMed
8.Keller, MB, Kocsis, JH, Thase, ME, et al.Maintenance phase efficacy of sertraline for chronic depression: a randomized controlled trial. JAMA. 1998;280:16651672.CrossRefGoogle ScholarPubMed
9.Lustman, PJ, Clouse, RE, Nix, BD. et al.Sertraline for prevention of depression recurrence in diabetes mellitus: a randomized, double-blind, placebo-controlled trial. Arch Gen Psychiatry. 2006;63:521529.CrossRefGoogle ScholarPubMed
10.Detke, MJ, Wiltse, CG, Mallinckrodt, CH, McNamara, RK, Demitrack, MA, Bitter, I. Duloxetine in the acute and long-term treatment of major depressive disorder: a placebo- and paroxetine-controlled trial. Eur Neuropsychopharmacol. 2004;14:457470.CrossRefGoogle ScholarPubMed
11.Gelenberg, AJ, Trivedi, MH, Rush, AJ, et al.Randomized, placebo-controlled trial of nefazodone maintenance treatment in preventing recurrence in chronic depression. Biol Psychiatry. 2003;54:806817.CrossRefGoogle ScholarPubMed
12.Gilaberte, I, Montejo, AL, de la Gandara, J, et al.Fluoxetine in the prevention of depressive recurrences: a double-blind study. J Clin Psychopharmacol. 2001;21:417424.CrossRefGoogle ScholarPubMed
13.Klysner, R, Bent-Hansen, J, Hansen, HL, et al.Efficacy of citalopram in the prevention of recurrent depression in elderly patients: placebo-controlled study of maintenance therapy. Br J Psychiatry. 2002;181:2935.CrossRefGoogle ScholarPubMed
14.Miner, CM, Brown, EB, Gonzales, JS, Munir, R. Switching patients from daily citalopram, paroxetine, or sertraline to once-weekly fluoxetine in the maintenance of response for depression. J Clin Psychiatry. 2002;63:232240.CrossRefGoogle ScholarPubMed
15.Rouillon, F, Warner, B, Pezous, N, Bisserbe, JC. Milnacipran efficacy in the prevention of recurrent depression: a 12-month placebo-controlled study. Milnacipran recurrence prevention study group. Int Clin Psychopharmacol. 2000;15:133140.CrossRefGoogle ScholarPubMed
16.Lenze, EJ, Dew, MA, Mazumdar, S, et al.Combined pharmacotherapy and psychotherapy as maintenance treatment for late-life depression: effects on social adjustment. Am J Psychiatry. 2002;159:466468.CrossRefGoogle ScholarPubMed
17.Fava, GA, Ruini, C, Rafanelli, C, Finos, L, Conti, S, Grandi, S. Six-year outcome of cognitive behavior therapy for prevention of recurrent depression. Am J Psychiatry. 2004;161:18721876.CrossRefGoogle ScholarPubMed
18.Solomon, DA, Leon, AC, Mueller, TI, et al.Tachyphylaxis in unipolar major depressive disorder. J Clin Psychiatry. 2005;66:283290.CrossRefGoogle ScholarPubMed
19.Posternak, MA, Zimmerman, M. Dual reuptake inhibitors incur lower rates of tachyphylaxis than selective serotonin reuptake inhibitors: a retrospective study. J Clin Psychiatry. 2005;66:705707.CrossRefGoogle ScholarPubMed
20.Rush, AJ, Koran, LM, Keller, MB, et al.The treatment of chronic depression, part 1: study design and rationale for evaluating the comparative efficacy of sertraline and imipramine as acute, crossover, continuation, and maintenance phase therapies. J Clin Psychiatry. 1998;59:589597.CrossRefGoogle ScholarPubMed
21.Thase, ME. Efficacy and tolerability of once-daily venlafaxine extended release (XR) in outpatients with major depression. The Venlafaxine XR 209 Study Group. J Clin Psychiatry. 1997;58:393398.CrossRefGoogle ScholarPubMed
22.Simon, JS, Aguiar, LM, Kunz, NR, Lei, D. Extended-release venlafaxine in relapse prevention for patients with major depressive disorder. J Psychiatr Res. 2004;38:249257.CrossRefGoogle ScholarPubMed