A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes.

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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), in bipolar disorder patients who had more than 4 mood episodes in the past year.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Janssen, LP
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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