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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Ortho Inc., Canada
• Treatments: Antipsychotic Agents; Risperidone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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