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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Extended release oxcarbazepine vs Immediate release oxcarbazepine
Dauten Family Center for Bipolar Treatment Innovation
Boston, Massachusetts, United States
Treatment Effectiveness
Treatment Effectiveness is defined as Response Rate (Change from Baseline MADRS \> or = 50%) X Completion Rate (completes week 6 of protocol while remaining on assigned treatment).
Time frame: 6 weeks
Tolerability
Tolerability is defined as the rate of completion without severe adverse effects reported by subject or clinician. The subject will complete an adverse effects self-report module as part of their "Online Pre-assessment" 1-3 days prior to each clinical visit. The clinician will review the pre-assessment and complete their own adverse effect report at each visit. Items rated as severe by either the subject or the clinician will will be counted as severe. Subjects who remain on study medication for 6 weeks without severe adverse effects will be scored as tolerating treatment.
Time frame: 6 weeks
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