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Risperidone With Standard Therapy Reduces Relapses of Bipolar Episode Regardless of Episode Type: Presented at CINP
By Bryan DeBusk, PhD
MUNICH, Germany -- July 18, 2008 -- Adding long-acting injectable risperidone to standard treatment for bipolar disorder reduces the frequency of relapses of manic, hypomanic, depressive, and mixed episodes, according to research presented here at the 26th Collegium Internationale Neuro-Psychopharmacologicum (CINP) Congress.
Larry Alphs, MD, PhD, Ortho-McNeil Janssen Scientific Affairs, Titusville, New Jersey, presented the results in a poster session on July 15.
Dr. Alphs and colleagues conducted a post hoc analysis of results from a randomised, double-blind, 52-week, placebo-controlled trial to evaluate the efficacy of injectable long-acting risperidone in combination with standard treatment with mood stabilisers, antidepressants, or anxiolytics compared with placebo plus standard treatment.
The study included 139 patients with frequently relapsing bipolar disorder who successfully completed a 16-week, open-label stabilisation phase. The researchers used a Cox proportional hazards model based on competing risk methodology to evaluate time to relapse of any manic, hypomanic, depressive, or mixed episode.
During 52 weeks of follow-up, 48 patients experienced a relapse. The frequency of relapse among patients receiving risperidone in addition to standard treatment was 22.2% compared with 47.8% of patients receiving placebo and standard treatment (P = .004).
Depressive episodes were reported for 12.5% of patients in the risperidone group compared with 20.9% of patients in the placebo group. Rates of manic episodes were 6.9% and 20.9%, respectively. Rates of mixed episodes were 2.8% and 6.0%, respectively.
The researchers observed a relative risk of relapse of 2.4 between treatment groups for each specific type of episode, which was comparable among relapse episode types (P = .650).
Dr. Alphs and colleagues concluded that adjunctive therapy with injectable long-acting risperidone can reduce the time to relapse regardless of the type of episode for patients with bipolar disorder.
Funding for this study was provided by Ortho-McNeil Janssen.
[Presentation title: Adjunctive Risperidone Long-Acting Injectable Reduces Relapse Independent of Episode Type in Remitted Patients With Frequently Relapsing Bipolar Disorder. Abstract P04-03]
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