Status:
COMPLETED
A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen, LP
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine the safety and effectiveness of the long acting injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with treatment as usual (TAU...
Detailed Description
Frequently-relapsing (more than 4 episodes in the last year) bipolar patients are a sub-group of patients who have multiple mood episodes in spite of treatment. Currently available treatments may have...
Eligibility Criteria
Inclusion
- Must provide informed consent
- Must agree to receive regular injections
- Must have current diagnosis of bipolar disorder I or II
- Must have at least four episodes of mood disorder in the last year that required psychiatric intervention
Exclusion
- Female who is or may be pregnant or breastfeeding, who is not at least 1 year postmenopausal, or is not using reliable and adequate birth control
- Psychiatric diagnosis is due directly to effects of a substance or general medical condition
- Substance dependence
- Received treatment with a long-acting injectable antipsychotic less than 2 injection cycles prior to baseline (so, for example, if the drug is injected every 2 weeks, the patient could not enroll in the study if they had received an injection within the last 4 weeks)
- Received Electroconvulsive Therapy (ECT) within the last month
- Began psychotherapy ("talk therapy") within 2 months
- In the past month was treated with any of these medications: carbamazepine, oxcarbazepine, fluoxetine, paroxetine, or clozapine
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00094926
Start Date
May 1 2004
End Date
February 1 2007
Last Update
May 19 2011
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