drugset / Trial / NCT00190892

Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania

NCT00190892 ↗

Phase 4 Completed 120 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial will assess any efficacious benefit and any safety issues associated with the concomitant use of olanzapine and carbamazepine for the treatment of patients with bipolar I disorder, manic or mixed episodes

Timeline

Start
2004-09
Primary completion
—
Completion
2006-06

Outcome

Missed primary endpoint

paper The combination of olanzapine and carbamazepine did not have superior efficacy to carbamazepine alone. PMID 18245032 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbamazepine Small molecule 400 mg —
Subject Carbamazepine Small molecule 1200 mg —
Subject Olanzapine Small molecule 10 mg —
Subject Olanzapine Small molecule 30 mg —

Indications