Exclusion criteria and generalizability in bipolar disorder treatment trials.

Objective: The current paper reviews the English-language research on exclusion criteria in bipolar disorder treatment trials and discusses how study samples compare to the general bipolar patient population.

Methods: & Results: Across 8 identified studies of exclusion criteria and their impact, between 55% and 96% of people with bipolar disorder would be excluded from treatment research. The number of exclusion criteria varies across bipolar disorder treatment research, with one study estimate of a median of 7 criteria used across studies. The criteria that excluded the greatest number of potential participants were comorbid substance use disorder, suicidal risk, and comorbid medical conditions. Both studies that compared treatment responses among participants who met and did not meet exclusion criteria found no statistically significant differences.

Conclusions: Most potential participants are excluded from outcome research, which creates challenges for recruitment and limits generalizability of study findings. Common exclusionary practices lead to unrepresentative samples that limit generalizability and reduce the confidence of clinicians that findings can be translated to front-line practice with bipolar disorder patients.