Archival ReportRisperidone Long-Acting Injectable Monotherapy in the Maintenance Treatment of Bipolar I Disorder
Section snippets
Patients
Men and women, aged 18 to 65 years (inclusive), body mass index ≥17 and ≤33 kg/m2, with a diagnosis of bipolar I disorder (DSM-IV-TR criteria [15]) were enrolled. Patients were eligible if they experienced an acute manic or mixed episode (with a Young Mania Rating Scale [YMRS] score ≥20) (16) or were stable (Clinical Global Impressions-Severity [CGI-S] Scale ≤3) on risperidone (oral or LAI) or on other oral antipsychotics or mood stabilizers but requiring change due to safety or tolerability
Patient Demographics and Characteristics
Patient disposition is shown in Figure S1 in Supplement 1. The double-blind treatment groups were generally well-balanced (Table 1). Most (77%) patients in the risperidone LAI group received a dose of 25 mg every 2 weeks. Median duration of exposure was 280.5 days for patients on risperidone LAI and 151 days for patients on placebo. Lorazepam was the most commonly used concomitant medication (5% risperidone LAI; 10% placebo).
The preplanned interim analysis was performed after the 66th
Discussion
The 1997 Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for management of bipolar disorder suggested that limited evidence existed to support use of first-generation antipsychotics in bipolar maintenance therapy and that individuals with mood disorders may be at particular risk for developing tardive dyskinesia (22). Further, in a small placebo-controlled trial, a first-generation depot neuroleptic did not have a prophylactic effect (23). In contrast, a credible database
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Vivek Kusumakar is deceased.