A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Placebo; Drug: Risperdal Consta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00132678

CR002278

RISBIM3003

Details and patient eligibility

About

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.

Full 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)

Enrollment: 559 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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559 participants in 2 patient groups, including a placebo group

001

Experimental group

Description:

Risperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks

Treatment:

Drug: Risperdal Consta

002

Placebo Comparator group

Description:

Placebo Matching placebo intramuscular (IM) injection every 2 weeks

Treatment:

Drug: Placebo