Carbamazepine Extended-Release for the Treatment of Bipolar Depression

Status Completed

Clinical Trial Summary

To study the efficacy and safety of beaded extended-release Carbamazepine (Equetro) in the treatment of patients with Bipolar Disorder with a Major Depressive Episode.

Clinical Trial Description

Patients with Bipolar I or II Disorder with a Major Depressive Episode who sign informed consent and meet eligibility criteria will begin treatment with extended release carbamazepine (ERC-CBZ ). The dose of ERC-CBZ will be initiated at 200mg twice daily and increased as tolerated by 200mg/day every 3 days up to 1200mg/day by week 2 (target dose). Then the dose may be increased at the investigator's discretion, up to1600mg/day as tolerated by week 8, if needed for a greater therapeutic response. Efficacy will be assessed biweekly with the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression-Bipolar (CGI-BP). Safety is assessed biweekly with adverse events self-reports and laboratory evaluations. ). ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00203567
Study type	Interventional
Source	Tuscaloosa Research & Education Advancement Corporation
Contact
Status	Completed
Phase	Phase 4
Start date	August 2005
Completion date	May 2008

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