A Randomized, Double-blind, Placebo-controlled Study to Explore the Efficacy and Safety of Risperidone Long-acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar 1 Disorder, With Open-label Extension
Overview
- Phase
- Phase 3
- Intervention
- Risperdal Consta
- Conditions
- Bipolar Disorder
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Enrollment
- 559
- Primary Endpoint
- Number of Participants Who Had a Mood Relapse.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or stable
- •Two or more bipolar mood episodes in the last 2 years excluding current episode
- •Negative pregnancy test
Exclusion Criteria
- •History of \> than 4 mood episodes a year during the last two years
- •patients experiencing a depressive episode
- •History of antisocial or borderline personality illness
- •Has unstable or serious general medical illness
- •Has received medications disallowed by study criteria.
Arms & Interventions
001
Risperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks
Intervention: Risperdal Consta
002
Placebo Matching placebo intramuscular (IM) injection every 2 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants Who Had a Mood Relapse.
Time Frame: 24 months
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.
Secondary Outcomes
- Change in Young Mania Rating Scale (YMRS) Scores.(Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV)
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS)(Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV)