RecruitingPhase 4NCT07213466

Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder

Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder - OBOE-Mayo


Sponsor

Mayo Clinic

Enrollment

100 participants

Start Date

Jan 19, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The main questions it aims to answer are: * Can the investigators compare the distribution of obesity characteristics (hungry brain, hungry gut, emotional hunger) between bipolar patients and non-bipolar participants (comparing from IRB #24-002375)? * Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder? Participation will last for about 20 weeks and includes 8 in-person study visits, up to 11 phone call visits, and 13 virtual group therapy sessions. The first visit lasts about 2 hours and includes going over the informed consent form, a diagnostic interview to confirm diagnosis, gathering vital signs, mood questionnaires, an ECG, a blood draw, and urine drug and pregnancy tests (if applicable). The second visit lasts about 6-7 hours and involves multiple procedures and completing questionnaires to determine which study drug would allow participants to lose weight most effectively. At the third visit, participants will be assigned to take one of three FDA approved medications for weight loss: Semaglutide (Wegovy®), Naltrexone/Bupropion (Contrave®), or Phentermine/Topiramate (Qsymia®). It is possible that participants could be assigned to a group that receives no study medication. All participants will be enrolled in a 12-week virtual group therapy program targeted for weight loss. On this third visit the investigators will also gather vital signs, and participants will give a sample of blood. After the third visit, participants will come in for study visits every 4 weeks for 20 weeks (5 visits) to assess medication adherence, vitals, and answer questions about mood and eating (participants will also give a sample of blood at the 8-week and 20-week visits). For participants assigned to a study medication, the study team will call every week for the first 2 months (excluding in-person visit weeks) to assess mood and safety. After the first 2 months, the study team will call the participant every two weeks in between in-person visits. Participants will be compensated for time spent in this study. Participants assigned to a study medication will also be given the option to participate in the open-label phase of the study, which involves 3 follow-up visits (weeks 24, 36, and 48) over 7 months after the 20-week trial. During this phase, participants can continue to take the medication through their clinical care provider.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different FDA-approved weight loss medications to see which works best for people with bipolar disorder who are also living with obesity. Because some medications can affect mood, the study takes a personalized approach based on each person's specific situation. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed diagnosis of bipolar disorder (type I, II, or schizoaffective bipolar type) - You have a BMI of 30 or higher, or a BMI of 27 or higher plus a condition like type 2 diabetes, high blood pressure, or sleep apnea - You are currently taking a mood stabilizer and your dose has been stable for at least 1 month - Your bipolar disorder is currently stable (not in a manic or psychotic episode) **You may NOT be eligible if...** - You have had weight loss surgery (gastric bypass, gastric sleeve, or lap band) - You have active bulimia or anorexia - You have active mania, psychosis, or serious suicidal thoughts - You have a current drug or alcohol use disorder (excluding nicotine) - You have significant untreated stomach or intestinal conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALGroup Therapy Program

a 12-week group therapy program centered around weight loss and healthy eating.

DRUGsemaglutide

Brand name: Wegovy

DRUGPhentermine-Topiramate

Brand name: Qsymia

DRUGnaltrexone and bupropion (combination)

Brand name: Contrave


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT07213466


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