Personalized Medication Approach for Weight Loss in Adults with Bipolar Disorder and Obesity Using FDA-Approved Anti-Obesity Drugs and Group Therapy

What this Trial Is About

Researchers are studying adults aged 18 to 65 with bipolar disorder and obesity to identify specific obesity characteristics, called phenotypes, that might help select the best medication for weight loss. This pilot study aims to compare obesity traits between bipolar and non-bipolar individuals and to evaluate the use of personalized anti-obesity medications in bipolar patients. The study also looks at how these medications are tolerated and how they affect mood and eating behaviors. Participants will be categorized into one of four obesity phenotypes Hungry Brain, Hungry Gut, Emotional Hunger, or Slow Burn. Based on their phenotype, participants will receive one of three FDA-approved weight loss medicationsSemaglutide Wegovy, NaltrexoneBupropion Contrave, or PhentermineTopiramate Qsymiaor behavioral and lifestyle interventions if in the Slow Burn group. All participants will join a 12-week virtual group therapy focused on weight loss, nutrition, physical activity, and relapse prevention. The treatment period lasts 20 weeks, with the option for an additional 7-month open-label phase for those on medication. Throughout the study, participants will attend a total of 8 in-person visits, up to 11 phone calls, and 13 virtual group sessions. Initial visits include diagnostic interviews, vital sign checks, mood questionnaires, ECGs, blood draws, and urine tests. Follow-up visits assess medication adherence, mood, eating behavior, and safety with blood samples collected at specific intervals. Researchers will monitor adverse events and mood symptoms closely to ensure participant safety. The study will measure obesity phenotype distribution, weight loss, metabolic changes, and behavioral outcomes over the intervention period.

Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder