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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132678
• Other study ID #: CR002278
• Secondary ID: RISBIM3003
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: July 23, 2013
• Start date: February 2005
• Est. completion date: December 2007

Study information

• Verified date: July 2013
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 559
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Risperdal Consta
12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks
• Placebo
Matching placebo intramuscular (IM) injection every 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

United States,  Austria,  India,  Malaysia,  Poland,  Russian Federation,  Slovakia,  Spain,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months	No
Secondary	Change in Young Mania Rating Scale (YMRS) Scores.	Measure of mania; score range 0 to 60 (lower score = less severity)	Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV	No
Secondary	Change in Montgomery-Åsberg Depression Rating Scale (MADRS)	Measure of depression; score range 0 to 60 (lower score = less severity)	Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV	No

External Links

•   A study of the efficacy and safety of injectable risperidone in the prevention of bipolar mood episodes