The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.
RISPERDAL CONSTA (risperidone long-acting injection) may provide substantial improvement, by reducing patient non-compliance, in the long-term treatment of bipolar I disorder. This is a randomized (patients are assigned different treatments based on chance), double-blind, (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) placebo-controlled study to explore the safety and effectiveness of RISPERDAL CONSTA in the prevention of mood episodes in patients with bipolar 1 disorder. This study includes 5 periods: a screening period lasting up to 1 week; an open-label RISPERDAL (oral risperidone) treatment period lasting 3 weeks; an open-label RISPERDAL CONSTA stabilization period lasting 26 weeks; a double-blind period lasting up to 24 months; and an open-label extension with RISPERDAL CONSTA lasting 8 weeks. Efficacy will be assessed using the Young Mania Rating Scale (YMRS), Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impressions - Severity (CGI-S) scale, Medical Outcomes Study Short Form 36 (SF-36), and the Personal and Social Performance (PSP) scale. Safety will be evaluated throughout the study and includes assessment of adverse events, clinical laboratory tests (including hematology, serum chemistry, blood glucose/lipid profile, prolactin, and urinalysis); electrocardiograms (ECGs), vital signs (pulse and blood pressure), physical examination, body mass index (BMI), and the Extrapyramidal Symptom Rating Scale (ESRS). Oral risperidone (flexible dosage) 1 to 6 mg/day for the first 3 weeks. Risperidone LAI i.m. injections (12.5mg, 25 mg, 37.5 mg, or 50 mg) given every 2 weeks for up to approximately 2.6 years (only 6 months for patients receiving placebo during DB-period)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
559
12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks
Matching placebo intramuscular (IM) injection every 2 weeks
Number of Participants Who Had a Mood Relapse.
Mood Relapse was defined as: The subject met DSM-IV criteria for a manic, hypomanic, mixed, or depressive episode; or, the subject needed treatment intervention with any mood stabilizer, antipsychotic medication (other than study drug), benzodiazepine (beyond the dosage allowed), or antidepressant medication; or the subject required hospitalization for any bipolar mood episode; or the subject had a YMRS or MADRS score \>12 or a CGI-S score \>4; or a dose increase, or supplementation with oral risperidone or another antipsychotic or mood stabilizer, was needed in the opinion of the investigator.
Time frame: 24 months
Change in Young Mania Rating Scale (YMRS) Scores.
Measure of mania; score range 0 to 60 (lower score = less severity)
Time frame: Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Measure of depression; score range 0 to 60 (lower score = less severity)
Time frame: Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV
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Little Rock, Arkansas, United States
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La Mesa, California, United States
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National City, California, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Hialeah, Florida, United States
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Lake Charles, Louisiana, United States
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Towson, Maryland, United States
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Clementon, New Jersey, United States
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Lyndhurst, Ohio, United States
...and 41 more locations