drugset / Trial / NCT01977300
Atypical Antipsychotics for Continuation and Maintenance Treatment After an Acute Manic Episode
Phase 3
Completed
159 enrolled
University of British Columbia
Canadian Institutes of Health Research (CIHR) · collabEli Lilly and Company · collabJanssen-Ortho Inc., Canada · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2003-01
- Primary completion
- 2011-08
- Completion
- 2011-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olanzapine | Small molecule | 5 mg | — |
| Subject | Olanzapine | Small molecule | 25 mg | — |
| Subject | Risperidone | Other / unclassified | 1 mg | — |
| Subject | Risperidone | Other / unclassified | 6 mg | — |
| Background | Lithium | Unknown | — | — |
| Background | Valproate | Small molecule | — | — |