A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Risperdal Consta (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Number of Participants Who Had a Mood Relapse.
Secondary outcome: Change in Young Mania Rating Scale (YMRS) Scores.Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
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)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Neunkirchen, Austria
Bangalore, India
Hyderabad, India
Manipal, India
Johor Bahru, Malaysia
Kota Bharu, Malaysia
Kuala Lumpur, Malaysia
Choroszcz N/A, Poland
Gdansk, Poland
Swiecie Poland, Poland
Tuszyn N/A, Poland
Lipetsk, Russian Federation
Moscow N/A, Russian Federation
Moscow Region, Russian Federation
Moscow Russia, Russian Federation
Nizny Novgorod, Russian Federation
Samara N/A, Russian Federation
Saratov N/A, Russian Federation
St Petersburg N/A, Russian Federation
St-Petersburg, Russian Federation
St-Petresburg, Russian Federation
Bratislava, Slovakia
Kosice, Slovakia
Rimavska Sobota, Slovakia
Barcelona, Spain
Madrid, Spain
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Tao-Yuan, Taiwan
Dnepropetrovsk, Ukraine
Glevakha, Ukraine
Kharkiv, Ukraine
Kiev, Ukraine
Lvov, Ukraine
Odessa, Ukraine
Simferopol, Ukraine
Vinnitsa, Ukraine
Little Rock, Arkansas, United States
La Mesa, California, United States
National City, California, United States
Washington, District of Columbia, United States
Bradenton, Florida, United States
Hialeah, Florida, United States
Lake Charles, Louisiana, United States
Towson, Maryland, United States
Clementon, New Jersey, United States
Lyndhurst, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Desoto, Texas, United States
Richmond, Virginia, United States
Additional Information
A study of the efficacy and safety of injectable risperidone in the prevention of bipolar mood episodes
Starting date: February 2005
Last updated: July 23, 2013
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