Actively Recruiting
Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder - OBOE-Mayo
Led by Mayo Clinic · Updated on 2026-03-11
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
U
University of Toronto
Collaborating Sponsor
AI-Summary
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 medications—Semaglutide (Wegovy), Naltrexone/Bupropion (Contrave), or Phentermine/Topiramate (Qsymia)—or 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.
CONDITIONS
Brief Title
Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women between 18 to 65 years old
- Confirmed diagnosis of bipolar disorder (BDI or BDII) or schizoaffective bipolar type
- Negative pregnancy test within 48 hours before study entry for women
- Negative urine drug screen except for allowable drugs
- Body mass index (BMI) of 30 or higher, or BMI of 27 or higher with at least one medical condition such as type 2 diabetes, hypertension, dyslipidemia, or obstructive sleep apnea
- On mood stabilizer treatment, possibly with antidepressant or anxiolytic therapy
- Stable mood stabilizer medication regimen for at least one month prior to enrollment
- Continuation of mood stabilizer treatment preferred but not required
You will not qualify if you...
- Previous bariatric surgery such as gastric bypass, adjustable gastric band, or gastric sleeve
- Chronic gastrointestinal diseases affecting motility or absorption, like diabetic gastroparesis, inflammatory bowel disease, celiac disease, or small intestinal bacterial overgrowth
- Use of medications that alter gastrointestinal motility or absorption
- Significant untreated psychiatric dysfunction
- Allergy or hypersensitivity to study medications
- Contraindications to phentermine-topiramate, naltrexone-bupropion, or semaglutide
- Inability to provide informed consent due to legal or mental health status
- Active hypomania or mania with high symptom scores
- Active psychosis or severe suicidal thoughts
- Recent changes to mood stabilizer medications without clinician approval
- Active or recent bulimia or anorexia
- Current drug or alcohol use disorders except nicotine
- Positive toxicology screen for prohibited substances or cannabis use disorder
- Refusal to complete full phenotyping procedures or dietary restrictions like gluten avoidance or vegan diet restrictions during phenotyping period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants undergo comprehensive obesity phenotyping including indirect calorimetry, gastric emptying scintigraphy, DEXA scans, ad libitum buffet meal testing, and behavioral questionnaires to classify obesity phenotype and determine appropriate treatment.
1 to 2 visits for phenotyping assessments
Duration - 16 weeks
Participants receive individualized treatment based on their obesity phenotype, including FDA-approved anti-obesity medications for Hungry Brain, Hungry Gut, and Emotional Hunger phenotypes, or behavioral and lifestyle interventions for the Slow Burn phenotype. All participants participate in a 12-week virtual behavioral group therapy program.
Weekly virtual group therapy sessions for 12 weeks; medication dosing follows phenotype-specific regimen
Duration - 4 weeks after treatment
Participants are monitored for safety, treatment adherence, and outcomes including weight loss, metabolic changes, mood symptoms, and eating behavior through the end of the 20-week intervention period.
Bi-monthly safety monitoring reviews and assessments as scheduled
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
L
Laura N Harper
K
Karin M Lindstrom, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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