Prevention of recurrent episodes of depression with venlafaxine ER in a 1-year maintenance phase from the PREVENT study

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, Anthony J. Rothschild, James M. Ferguson, Alan F. Schatzberg, John M. Zajecka, Ronald D. Pedersen, Bing Yan, Saeed Ahmed, Jeff Musgnung, Philip T. Ninan, Martin B. Keller

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)1014-1023
Number of pages10
JournalJournal of Clinical Psychiatry
Volume68
Issue number7
StatePublished - Jul 2007

Fingerprint

Maintenance
Depression
Fluoxetine
Placebos
Recurrence
Therapeutics
Venlafaxine Hydrochloride
Depressive Disorder
Diagnostic and Statistical Manual of Mental Disorders
Clinical Trials
Safety

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

Kocsis, J. H., Thase, M. E., Trivedi, M. H., Shelton, R. C., Kornstein, S. G., Nemeroff, C. B., ... Keller, M. B. (2007). Prevention of recurrent episodes of depression with venlafaxine ER in a 1-year maintenance phase from the PREVENT study. Journal of Clinical Psychiatry, 68(7), 1014-1023.

Prevention of recurrent episodes of depression with venlafaxine ER in a 1-year maintenance phase from the PREVENT study. / Kocsis, James H.; Thase, Michael E.; Trivedi, Madhukar H.; Shelton, Richard C.; Kornstein, Susan G.; Nemeroff, Charles B.; Friedman, Edward S.; Gelenberg, Alan J.; Dunner, David L.; Hirschfeld, Robert M A; Rothschild, Anthony J.; Ferguson, James M.; Schatzberg, Alan F.; Zajecka, John M.; Pedersen, Ronald D.; Yan, Bing; Ahmed, Saeed; Musgnung, Jeff; Ninan, Philip T.; Keller, Martin B.

In: Journal of Clinical Psychiatry, Vol. 68, No. 7, 07.2007, p. 1014-1023.

Research output: Contribution to journalArticle

Kocsis, JH, Thase, ME, Trivedi, MH, Shelton, RC, Kornstein, SG, Nemeroff, CB, Friedman, ES, Gelenberg, AJ, Dunner, DL, Hirschfeld, RMA, Rothschild, AJ, Ferguson, JM, Schatzberg, AF, Zajecka, JM, Pedersen, RD, Yan, B, Ahmed, S, Musgnung, J, Ninan, PT & Keller, MB 2007, 'Prevention of recurrent episodes of depression with venlafaxine ER in a 1-year maintenance phase from the PREVENT study', Journal of Clinical Psychiatry, vol. 68, no. 7, pp. 1014-1023.
Kocsis JH, Thase ME, Trivedi MH, Shelton RC, Kornstein SG, Nemeroff CB et al. Prevention of recurrent episodes of depression with venlafaxine ER in a 1-year maintenance phase from the PREVENT study. Journal of Clinical Psychiatry. 2007 Jul;68(7):1014-1023.
Kocsis, James H. ; Thase, Michael E. ; Trivedi, Madhukar H. ; Shelton, Richard C. ; Kornstein, Susan G. ; Nemeroff, Charles B. ; Friedman, Edward S. ; Gelenberg, Alan J. ; Dunner, David L. ; Hirschfeld, Robert M A ; Rothschild, Anthony J. ; Ferguson, James M. ; Schatzberg, Alan F. ; Zajecka, John M. ; Pedersen, Ronald D. ; Yan, Bing ; Ahmed, Saeed ; Musgnung, Jeff ; Ninan, Philip T. ; Keller, Martin B. / Prevention of recurrent episodes of depression with venlafaxine ER in a 1-year maintenance phase from the PREVENT study. In: Journal of Clinical Psychiatry. 2007 ; Vol. 68, No. 7. pp. 1014-1023.
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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.",
author = "Kocsis, {James H.} and Thase, {Michael E.} and Trivedi, {Madhukar H.} and Shelton, {Richard C.} and Kornstein, {Susan G.} and Nemeroff, {Charles B.} and Friedman, {Edward S.} and Gelenberg, {Alan J.} and Dunner, {David L.} and Hirschfeld, {Robert M A} and Rothschild, {Anthony J.} and Ferguson, {James M.} and Schatzberg, {Alan F.} and Zajecka, {John M.} and Pedersen, {Ronald D.} and Bing Yan and Saeed Ahmed and Jeff Musgnung and Ninan, {Philip T.} and Keller, {Martin B.}",
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AU - Kocsis, James H.

AU - Thase, Michael E.

AU - Trivedi, Madhukar H.

AU - Shelton, Richard C.

AU - Kornstein, Susan G.

AU - Nemeroff, Charles B.

AU - Friedman, Edward S.

AU - Gelenberg, Alan J.

AU - Dunner, David L.

AU - Hirschfeld, Robert M A

AU - Rothschild, Anthony J.

AU - Ferguson, James M.

AU - Schatzberg, Alan F.

AU - Zajecka, John M.

AU - Pedersen, Ronald D.

AU - Yan, Bing

AU - Ahmed, Saeed

AU - Musgnung, Jeff

AU - Ninan, Philip T.

AU - Keller, Martin B.

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N2 - 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.

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