drugset / Trial / NCT00976794

Efficacy of Combined Treatment for Young Bipolar I Disorder

NCT00976794 ↗

Phase 4 Completed 40 enrolled University of Sao Paulo
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to determine the efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients.

Timeline

Start
2009-01
Primary completion
2012-06
Completion
2012-06

Outcome

Missed primary endpoint

paper We found no between-group differences in CGI-BP (Clinical Global Impression Scale modified for use in bipolar disorder) scores (P = 0.326) or in any other outcome. PMID 31655626 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbamazepine Small molecule 600 mg —
Comparator Valproic Acid Small molecule 500 mg —
Background Lithium Unknown 600 mg —

Indications