The Stanley Foundation Bipolar Treatment Outcome Network. I. Longitudinal methodology.

Area of Science:

• Neuroscience
• Psychiatry
• Clinical Trials

Background:

• Bipolar disorder research has neglected long-term treatment efficacy and predictors of response.
• A multisite clinical trials network is needed to address these research gaps.

Purpose of the Study:

• To establish the NIMH-Stanley Foundation Bipolar Treatment Outcome Network for rigorous, long-term assessment of bipolar disorder treatments.
• To enroll representative patients and identify clinical and biological predictors of treatment response.

Main Methods:

• Conducting randomized clinical trials (blinded and open-label) in academic and community settings.
• Employing a systematic, longitudinal approach with comprehensive patient assessments.
• Utilizing the NIMH-Life Chart Method and modified Clinical Global Impressions Scale for Bipolar Illness (CGI-BP) for daily ratings.
• Incorporating detailed cross-sectional assessments for depression, mania, and psychosis at academic centers.

Main Results:

• The network systematically assesses the highly variable course of bipolar illness.
• Data are collected on treatment efficacy at critical clinical decision points.
• Patient data include daily severity ratings and functional impairment.

Conclusions:

• The network's design facilitates comprehensive, long-term evaluation of bipolar disorder treatments.
• It aims to improve understanding of illness variability and treatment response predictors.
• This approach will inform the development of new and existing treatment strategies.