Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression
Status:
Unknown status
Trial end date:
2019-09-30
Target enrollment:
Participant gender:
Summary
Consenting subjects with Bipolar depression will remain under the care of their local
(psychiatric) care provider and be randomized to a six week course of one of two forms of
oxcarbazepine (extended release or immediate release. Study outcomes will be assessed based
on outcome measures administered to the subject at home by a computer simulated rater. Local
care providers will receive "pre-assessment" reports ahead of each clinical visit, rate the
Clinical Global Impression for Severity, and evaluate adverse effects. The primary outcome
variable is "treatment effectiveness" operationally defined as the response rate X the
completion rate.
Phase:
Phase 4
Details
Lead Sponsor:
Collaborative Care Initiative, LLC
Collaborator:
Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen Hospital