Atypical Antipsychotics for Continuation and Maintenance Treatment After an Acute Manic Episode

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: Continuation of an atypical antipsychotic medication in combination with a Mood Stabilizer, following remission from an acute manic episode, lowers the rates of relapse and recurrence of mood episodes compared to discontinuing the antipsychotics within days of resolution of manic symptoms.

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

Details

• Lead Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR); Eli Lilly and Company; Janssen-Ortho Inc., Canada
• Treatments: Antipsychotic Agents; Lithium Carbonate; Olanzapine; Risperidone; Valproic Acid

Criteria

Inclusion Criteria:

• Patients who were recently (within the last 12 weeks) commenced on treatment for a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) manic or mixed episode with a combination of lithium and risperidone, lithium and olanzapine, valproate and risperidone, or valproate and olanzapine;

• Patients on 1 to 6 mg of risperidone or 5 to 25 mg of olanzapine

• Patients who are in remission from mania for at least 2 weeks but no more than 6 weeks and have maintained remission for 2 consecutive weeks;

• Patients must not be taking any other psychotropic medication (with the exception of benzodiazepines) or treatments including bromocriptine, omega 3 fatty acids, Axid or EMPower;

• Patients aged 17 and above.

Exclusion Criteria:

• Any subjects who do not meet the above inclusion criteria will be excluded from the study.

• In order for the findings to be generalizable to clinically representative patients with bipolar disorder, any patients with a history of co-morbid substance abuse or medical illnesses will not be excluded.