Finding studies
Finding studies
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Lead
Collaborative Care Initiative, LLC
With
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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
