| Autor: |
Alan J. Gelenberg, Richard C. Shelton, Robert M. A. Hirschfeld, Martin B. Keller, Anthony J. Rothschild, James H. Kocsis, Jeff Musgnung, Philip T. Ninan, John Zajecka, Ronald Pedersen, Michael E. Thase, Alan F. Schatzberg, Charles B. Nemeroff, James M. Ferguson, David L. Dunner, Edward S. Friedman, Madhukar H. Trivedi, Susan G. Kornstein, Saeeduddin Ahmed, Bing Yan |
| Rok vydání: |
2007 |
| Předmět: |
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| Zdroj: |
The Journal of Clinical Psychiatry. 68:1246-1256 |
| ISSN: |
0160-6689 |
| DOI: |
10.4088/jcp.v68n0812 |
| Popis: |
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) |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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