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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 I Disorder, with Open-Label Extension

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 I Disorder, with Open-Label Extension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-003781-14-AT
Enrollment
600
Registered
2004-10-28
Start date
2004-12-02
Completion date
Unknown
Last updated
2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BIPOLAR MANIA

Interventions

Trade Name: Risperdal Consta Product Name: Risperdal CONSTA 50mg Product Code: F109 Pharmaceutical Form: Suspension for injection INN or Proposed INN: risperidone Concentration unit: mg milligram(s) C

Sponsors

Johnson & Johnson Pharmaceutical Research and Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Male or female between theages of 18-65 Diagnosis of bipoar I disorder as defined by DSM-IV-TR Currently experienceing a manic or mixed episode or stable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of more that 4 mood episodes each year (rapid cycling) Meets DSM-IV-TR criteria for depressive episode, antisocial or borderline personality disorder Has an unstable serious medical ilness Known or suspected history of substance abuse withing helast 6 months Significant risk of injuring him/herself or others or causing significant damage to property

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of risperidone LAI versus placebo in the prevention of mood episode (relapse prevention) insubjects with bipolar I disorder after a 26-week (6-month) stabilization period on risperidone LAI, as measured by the time, to relapse of mood episode.;Secondary Objective: To evaluate: the prevention of a mood episode (sustained efficacy of maitenance treatment) with risperidone LAI versus placebo as measured by 1) the time to relapse of an elevated mood 2) the time to relapse of a depressive episode To evalute overall duration of treatment of risperidone as measured by time to early discontinuation from study medication To evaluate the sustained efficacy of maintenance treatment with risperidone LAI versus placebo, using the YMRS, MADRS, CGI-s To evaluate the sustained effect of maintenance treatmentwith risperidone LAI versus placebo on mental status using SF-36 To evaluate long-term safety of risperidoend LAI in subjects with bipolar 1 disorder;Primary end point(s):—

Countries

Austria, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026