A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Risperdal Consta Drug: Placebo	Phase III

MedlinePlus related topics:

Bipolar Disorder

Drug Information available for:

Risperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

The time from randomization to relapse of a mood episode in the double-blind period. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to relapse in double-blind period of an elevated-mood episode (manic, hypomanic, or mixed) and a depressive episode [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment:	564
Study Start Date:	January 2005
Study Completion Date:	December 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
001: Experimental	Drug: Risperdal Consta 12.5, 25, 37.5 or 50mg IM injection every 2 wks
002: Placebo Comparator	Drug: Placebo matching placebo IM injection every 2 wks

Detailed Description:

Risperidone LAI 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 the long-acting intramuscular injection of risperidone 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 oral risperidone treatment period lasting 3 weeks; an open-label risperidone LAI stabilization period lasting 26 weeks; a double-blind period lasting up to 24 months; and an open-label extension with risperidone LAI 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)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132678

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators


Study Director:	Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

A study of the efficacy and safety of injectable risperidone in the prevention of bipolar mood episodes This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Senior Director, Clinical Leader )
Study ID Numbers:	CR002278, RISBIM3003
First Received:	June 30, 2005
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00132678
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Intramuscular Injectable

Mood episodes

safety and efficacy

Risperdone

Bipolar 1 disorder

Study placed in the following topic categories:

Affective Disorders, Psychotic

Dopamine

Mental Disorders

Bipolar Disorder

Risperidone

Mood Disorders

Psychotic Disorders

Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents

Disease

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Dopamine Antagonists

Antipsychotic Agents

Pharmacologic Actions

Serotonin Antagonists

Pathologic Processes

Serotonin Agents

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00132678