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Title: Two Years of Venlafaxine XR Maintenance Prevents Recurrence in Patients With Recurrent Unipolar Major Depression: Presented at APA

"Two Years of Venlafaxine XR Maintenance Prevents Recurrence in Patients With Recurrent Unipolar Major Depression: Presented at APA"

By Danny Kucharsky TORONTO, CANADA -- May 29, 2006 -- Recurrence of depression can be prevented for up to 2 years with venlafaxine extended release (XR), according to findings from a study presented here at the American Psychiatric Association Annual Meeting (APA). Martin Keller, MD, professor and chairman, department of psychiatry and human behavior, Brown University, Providence, Rhode Island, presented the Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) study on May 23[^rd.

The multicenter, double-blind, placebo-controlled study is the second-year maintenance phase from a 4-phase long-term study evaluating the efficacy and safety of venlafaxine XR in preventing recurrence of depression. Recurrence after remission occurs often for most people with depression, noted investigator.

The study followed outpatients with major depression through acute, continuation, and 2 maintenance phases with venlafaxine XR. These patients were compared against a placebo group and a fluoxetine reference group.

The analysis included 1096 adults with a history of 2 or more episodes of major depression during the past 5 years, including their current episode. Patients had also experienced at least 3 episodes of depression during their lifetime. Eighty percent of patients had previously received antidepressant therapy.

During the acute treatment phase, patients were randomly assigned to receive venlafaxine XR 75 to 300 mg/day or fluoxetine 20 to 60 mg/day for 10 weeks. Those who achieved a satisfactory therapeutic response entered a 6-month continuation phase on the same drug. Those who responded to that phase entered the maintenance phase, consisting of 2 consecutive 12-month periods.

At the beginning of each maintenance period, venlafaxine XR responders were randomly assigned to receive treatment with venlafaxine XR or placebo, while fluoxetine responders continued to receive fluoxetine during each study phase.

Results from the 2 consecutive 12-month phases indicated that patients treated with venlafaxine XR were significantly more likely to remain recurrence-free compared with placebo-treated patients. The probability of recurrence was 23.1% among the 164 patients given venlafaxine XR compared with 42.0% among the 172 placebo patients (P =.005).

The difference between treatment arms was greater in the second maintenance phase, with an 8.0% likelihood of recurrence among the 43 patients given venlafaxine XR compared with 44.8% among the 40 patients given placebo (P <.001).

Adverse events were comparable to placebo. During the second year of maintenance, the discontinuation rates were 28% in the venlafaxine XR group and 63% in the placebo group.

Dr. Keller said the study data show that venlafaxine XR "can help prevent new episodes of depression."

The study was sponsored by Wyeth Pharmaceuticals.

[Presentation title: Recurrence Prevention: Efficacy of Two Years of Maintenance Treatment With Venlafaxine XR in Patients With Recurrent Unipolar Major Depression. Abstract NR528]

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