A Randomized, Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar Disorder

NCT00246246 | Completed Phase 3

• 1 other identifier: CR005818
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and effectiveness of a long-acting injectable formulation of risperidone in stable bipolar patients randomly switched from their current add-on oral antipsychotic (olanzapine, risperidone, or quetiapine) therapy to long-acting injectable risperidone. The patients switched to long-acting injectable risperidone will be compared to patients who continue on their oral antipsychotic treatment regimen

Conditions

Bipolar Disorder

Keywords

risperidone; long-acting injectable; bipolar disorder; intramuscular injection

Outcome Measures

Primary Outcomes (1)

• Changes in the Clinical Global Impression - Severity of Illness subscale (CGI-S) from baseline to endpoint, compared between treatment groups

Secondary Outcomes (1)

• Changes from baseline in the YMRS, MADRS and HAM-A at Months 1 - 6 and endpoint; resource utilization (emergency room visits, hospitalizations); quality of life; patient satisfaction with treatment; time to intervention for manic and depressive episodes

Interventions

risperidone DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable outpatients meeting the DSM-IV criteria for Bipolar I or Bipolar II Disorder
• YMRS score of \<= 19, MADRS score \<= 19 and the Clinical Global Impression - Severity of Illness subscale (CGI-S) score \<= 4 at screening and baseline
• Must be receiving stable doses of one oral atypical antipsychotic (olanzapine, risperidone, or quetiapine) in combination with a maximum of two of lithium, valproate or lamotrigine, and, if applicable, one antidepressant)
• Subject is healthy on the basis of a pre-trial physical examination, medical history and the results of blood biochemistry, hematology tests or urinalysis tests within 2 weeks of randomization (i.e. during screening)
• Female subjects must be postmenopausal (for at least 1 year), surgically sterile, or practicing an effective method of birth control before entry and throughout the study, and have a negative urine pregnancy test at screening and baseline

You may not qualify if:

• Have a serious unstable medical illness
• Had previous treatment with a long-acting injectable antipsychotic medication
• Known to be a risperidone non-responder or have a confirmed or suspected history of hypersensitivity or allergy to risperidone
• Patients at imminent risk of injury to self or others, or of causing significant damage to property
• Current drug or alcohol dependence

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen-Ortho Inc. Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: January 1, 2004
• Study Completion: April 1, 2006
• Last Updated: February 11, 2011

Record last verified: 2011-02