NCT00203567

Carbamazepine Extended-Release for the Treatment of Bipolar Depression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Tuscaloosa Research & Education Advancement Corporation · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. ).

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	carbamazepine ER	Active study drug, no comparator

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-02-01
• Completion: 2008-05-01
• First posted: 2005-09-20
• Last updated: 2008-06-24

Locations

1 site across 1 country: United States