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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-├ůsberg 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-├ůsberg 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

Page last updated: August 23, 2015

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