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Completed

NCT Number: NCT00132678

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

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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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neunkirchen, Austria

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RISPERDAL CONSTA

Drug

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

Placebo

Drug

Matching placebo intramuscular (IM) injection every 2 weeks

Primary outcomes

  1. Number of Participants Who Had a Mood Relapse.

    Time frame: 24 months

    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 outcomes

  1. Change in Young Mania Rating Scale (YMRS) Scores.

    Time frame: Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV

    Measure of mania; score range 0 to 60 (lower score = less severity)

  2. Change in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV

    Measure of depression; score range 0 to 60 (lower score = less severity)

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 22, 2005
Registry last updated
Jul 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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