Co-occurrence of serious or undiagnosed medical conditions with bipolar disorder preventing clinical trial randomization: a case series.

ABSTRACT

OBJECTIVE: Studies have shown that patients with bipolar disorder have high rates of serious and/or untreated co-occurring general medical conditions. This case series examined reports of co-occurring medical conditions with bipolar disorder in potential clinical study participants, and in particular the percentage of these individuals who were previously unaware of their conditions. METHOD: Patients were potential participants in 1 of 2 medication trials who met DSM-IV criteria for bipolar disorder and were excluded from those studies just prior to randomization from May 2009 through July 2011. Patients were compared with each other on a number of demographic criteria, including age, race, gender, reason for exclusion from the trial, and psychiatric diagnoses. RESULTS: Of the patients excluded from the studies just prior to randomization, 31% (n = 10) were excluded because of medical conditions previously unreported by the patient during screening for these studies. Seventy percent of those excluded patients (n = 7) had no prior knowledge of their conditions. CONCLUSIONS: These results suggest that patients with bipolar disorder may not only have high rates of co-occurring medical conditions but also frequently remain unaware of those conditions. These findings indicate that co-occurring general medical conditions may be a more serious problem in the treatment of bipolar disorder than previously appreciated and that more stringent monitoring and guidelines are needed regardless of medication regimen. This case series asserts that, regardless of a patient's claim of having no medical conditions, more general medical screening may be needed in outpatient psychiatric settings.