Bipolar Depression Clinical Trial
Official title:
An Exploratory Randomized Open Comparison of Oxtellar XR® vs Oxcarbazepine IR (Trileptal®) for the Treatment of Bipolar Depression
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.
This study will use the CCI Engaged Practice platform (EngagedPractice.Com) and will be
conducted by a central "meta-site" reviewing eligibility, obtaining consent, randomizing
subjects to treatment groups, training local care providers (LCP) to function as sub-
investigators and monitoring outcomes.
Subjects will be randomized to six weeks of treatment with extended release oxcarbazepine or
immediate release oxcarbazepine,while remaining under the care of their existing LCP.
LCP's will receive sub-investigator training for Good Clinical Practice, Human subjects
protection, and all protocol specified assessments and procedures.
A computer simulated rater will collect outcomes (including MADRS, YMRS, PHQ-9, and adverse
effects) ahead of each routine clinical visit and provide Measure-based Guidance o the LCP in
the form of pre-assessment reports. The primary outcome variable is "treatment effectiveness"
operationally defined as the response rate X the completion rate.
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