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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Risperdal Consta
Placebo
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bipolar Disorder focused on measuring Mood episodes, Bipolar 1 disorder, Intramuscular Injectable, risperidone, safety and efficacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

001

002

Arm Description

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

Placebo Matching placebo intramuscular (IM) injection every 2 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Young Mania Rating Scale (YMRS) Scores.
Measure of mania; score range 0 to 60 (lower score = less severity)
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Measure of depression; score range 0 to 60 (lower score = less severity)

Full Information

First Posted
June 30, 2005
Last Updated
July 23, 2013
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00132678
Brief Title
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Mood episodes, Bipolar 1 disorder, Intramuscular Injectable, risperidone, safety and efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
559 (Actual)

8. Arms, Groups, and Interventions

Arm Title
001
Arm Type
Experimental
Arm Description
Risperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks
Arm Title
002
Arm Type
Placebo Comparator
Arm Description
Placebo Matching placebo intramuscular (IM) injection every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Risperdal Consta
Intervention Description
12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo intramuscular (IM) injection every 2 weeks
Primary Outcome Measure Information:
Title
Number of Participants Who Had a Mood Relapse.
Description
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
Secondary Outcome Measure Information:
Title
Change in Young Mania Rating Scale (YMRS) Scores.
Description
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
Title
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States
City
La Mesa
State/Province
California
Country
United States
City
National City
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Lake Charles
State/Province
Louisiana
Country
United States
City
Towson
State/Province
Maryland
Country
United States
City
Clementon
State/Province
New Jersey
Country
United States
City
Lyndhurst
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Desoto
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Neunkirchen
Country
Austria
City
Bangalore
Country
India
City
Hyderabad
Country
India
City
Manipal
Country
India
City
Johor Bahru
Country
Malaysia
City
Kota Bharu
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Choroszcz N/A
Country
Poland
City
Gdansk
Country
Poland
City
Swiecie Poland
Country
Poland
City
Tuszyn N/A
Country
Poland
City
Lipetsk
Country
Russian Federation
City
Moscow N/A
Country
Russian Federation
City
Moscow Region
Country
Russian Federation
City
Moscow Russia
Country
Russian Federation
City
Nizny Novgorod
Country
Russian Federation
City
Samara N/A
Country
Russian Federation
City
Saratov N/A
Country
Russian Federation
City
St Petersburg N/A
Country
Russian Federation
City
St-Petersburg
Country
Russian Federation
City
St-Petresburg
Country
Russian Federation
City
Bratislava
Country
Slovakia
City
Kosice
Country
Slovakia
City
Rimavska Sobota
Country
Slovakia
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Taichung
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
Country
Taiwan
City
Tao-Yuan
Country
Taiwan
City
Dnepropetrovsk
Country
Ukraine
City
Glevakha
Country
Ukraine
City
Kharkiv
Country
Ukraine
City
Kiev
Country
Ukraine
City
Lvov
Country
Ukraine
City
Odessa
Country
Ukraine
City
Simferopol
Country
Ukraine
City
Vinnitsa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
20227682
Citation
Quiroz JA, Yatham LN, Palumbo JM, Karcher K, Kushner S, Kusumakar V. Risperidone long-acting injectable monotherapy in the maintenance treatment of bipolar I disorder. Biol Psychiatry. 2010 Jul 15;68(2):156-62. doi: 10.1016/j.biopsych.2010.01.015. Epub 2010 Mar 15.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=27&filename=CR002278_CSR.pdf
Description
A study of the efficacy and safety of injectable risperidone in the prevention of bipolar mood episodes

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

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