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

NCT ID: NCT00132678

Last Updated: 2013-07-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

559 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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001

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

Group Type EXPERIMENTAL

Risperdal Consta

Intervention Type DRUG

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

002

Placebo Matching placebo intramuscular (IM) injection every 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo intramuscular (IM) injection every 2 weeks

Interventions

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Risperdal Consta

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

Intervention Type DRUG

Placebo

Matching placebo intramuscular (IM) injection every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

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Little Rock, Arkansas, United States

Site Status

La Mesa, California, United States

Site Status

National City, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Bradenton, Florida, United States

Site Status

Hialeah, Florida, United States

Site Status

Lake Charles, Louisiana, United States

Site Status

Towson, Maryland, United States

Site Status

Clementon, New Jersey, United States

Site Status

Lyndhurst, Ohio, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

DeSoto, Texas, United States

Site Status

Richmond, Virginia, United States

Site Status

Neunkirchen, , Austria

Site Status

Bangalore, , India

Site Status

Hyderabad, , India

Site Status

Manipal, , India

Site Status

Johor Bahru, , Malaysia

Site Status

Kota Bharu, , Malaysia

Site Status

Kuala Lumpur, , Malaysia

Site Status

Choroszcz, , Poland

Site Status

Gdansk, , Poland

Site Status

Swiecie Poland, , Poland

Site Status

Tuszyn, , Poland

Site Status

Lipetsk, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow Region, , Russia

Site Status

Moscow Russia, , Russia

Site Status

Nizny Novgorod, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Samara, , Russia

Site Status

Saratov, , Russia

Site Status

St-Petresburg, , Russia

Site Status

Bratislava, , Slovakia

Site Status

Košice, , Slovakia

Site Status

Rimavská Sobota, , Slovakia

Site Status

Barcelona, , Spain

Site Status

Madrid, , Spain

Site Status

Taichung, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taoyuan District, , Taiwan

Site Status

Dnipro, , Ukraine

Site Status

Hlevakha, , Ukraine

Site Status

Kharkiv, , Ukraine

Site Status

Kiev, , Ukraine

Site Status

Lviv, , Ukraine

Site Status

Odesa, , Ukraine

Site Status

Simferopol, , Ukraine

Site Status

Vinnitsa, , Ukraine

Site Status

Countries

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United States Austria India Malaysia Poland Russia Slovakia Spain Taiwan Ukraine

References

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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.

Reference Type DERIVED
PMID: 20227682 (View on PubMed)

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=27&filename=CR002278_CSR.pdf

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

Other Identifiers

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RISBIM3003

Identifier Type: -

Identifier Source: secondary_id

CR002278

Identifier Type: -

Identifier Source: org_study_id

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