A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
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
2 other identifiers
interventional
559
10 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2005
Typical duration for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
August 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
February 27, 2009
CompletedJuly 29, 2013
July 1, 2013
2.7 years
June 30, 2005
October 24, 2008
July 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Change in Young Mania Rating Scale (YMRS) Scores.
Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV
Study Arms (2)
001
EXPERIMENTALRisperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks
002
PLACEBO COMPARATORPlacebo Matching placebo intramuscular (IM) injection every 2 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Little Rock, Arkansas, United States
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La Mesa, California, United States
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National City, California, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Hialeah, Florida, United States
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Lake Charles, Louisiana, United States
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Towson, Maryland, United States
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Clementon, New Jersey, United States
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Lyndhurst, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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DeSoto, Texas, United States
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Richmond, Virginia, United States
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Neunkirchen, Austria
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Bangalore, India
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Hyderabad, India
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Manipal, India
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Johor Bahru, Malaysia
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Kota Bharu, Malaysia
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Kuala Lumpur, Malaysia
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Choroszcz, Poland
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Gdansk, Poland
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Swiecie Poland, Poland
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Tuszyn, Poland
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Lipetsk, Russia
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Moscow, Russia
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Moscow Region, Russia
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Moscow Russia, Russia
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Nizny Novgorod, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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St-Petresburg, Russia
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Bratislava, Slovakia
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Košice, Slovakia
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Rimavská Sobota, Slovakia
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Barcelona, Spain
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Madrid, Spain
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Dnipro, Ukraine
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Hlevakha, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Simferopol, Ukraine
Unknown Facility
Vinnitsa, Ukraine
Related Publications (1)
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.
PMID: 20227682DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Research
- Organization
- Johnson & Johnson Pharmaceutical Research and Development
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2005
First Posted
August 22, 2005
Study Start
February 1, 2005
Primary Completion
October 1, 2007
Study Completion
December 1, 2007
Last Updated
July 29, 2013
Results First Posted
February 27, 2009
Record last verified: 2013-07