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Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression

Collaborative Care Initiative, LLC · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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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.
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