Actively Recruiting
Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
Led by Mayo Clinic · Updated on 2026-03-11
100
Participants Needed
1
Research Sites
158 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
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.
CONDITIONS
Official 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 (SZA-BD) by SCID IV.
- Women must have a negative pregnancy test within 48 hours before study entry.
- Negative urine drug screen except for allowable drugs.
- Body mass index (BMI) of at least 30 kg/m2 or BMI of at least 27 kg/m2 with one medical comorbidity such as type 2 diabetes, hypertension, dyslipidemia, or obstructive sleep apnea.
- Currently undergoing mood stabilizer treatment; concurrent antidepressant or anxiolytic therapy allowed.
- Stable mood stabilizer regimen with no changes for at least one month before enrollment.
- Preference for continued mood stabilizer treatment, decided with primary mental health provider.
You will not qualify if you...
- Prior abdominal bariatric surgery including gastric bypass, adjustable gastric band, or gastric sleeve.
- History of chronic gastrointestinal diseases or systemic diseases affecting gastrointestinal motility or absorption, such as 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.
- Hypersensitivity or contraindications to study medications (Phentermine-Topiramate ER, Naltrexone-Bupropion ER, Semaglutide).
- Inability to provide informed consent due to involuntary commitment, conservatorship, or legal guardianship.
- Active hypomania or mania with high symptom scores.
- Active psychosis.
- Active suicidal ideation.
- Recent changes to mood stabilizer medications without clinician approval.
- Active or recent (within 12 months) bulimia or anorexia.
- Current drug or alcohol use disorders except nicotine.
- Positive toxicology screen except cannabis; cannabis use disorder by CUDIT-R.
- Inability or unwillingness to complete the full phenotyping day, including dietary restrictions such as gluten avoidance or vegan diet.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
L
Laura N Harper
CONTACT
K
Karin M Lindstrom, Ph.D.
CONTACT
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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