Status:
COMPLETED
A Randomized, Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar Disorder
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ora...
Detailed Description
This an open-label, randomized study. Approximately 40 stable bipolar patients who are on an atypical antipsychotic (olanzapine, risperidone, quetiapine) plus adjunct bipolar treatment consisting of (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00246246
Start Date
January 1 2004
End Date
April 1 2006
Last Update
February 11 2011
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