Individualized Approach to Weight Loss for Bipolar Disorder
This study is looking into new ways to help people with bipolar I disorder, bipolar II disorder, or schizoaffective disorder who also have obesity. Researchers want to understand different reasons why people gain weight (like "hungry brain" or "emotional hunger") to see if matching specific weight-loss medications to these reasons works better. You might receive one of three FDA-approved medications: semaglutide (Wegovy), phentermine-topiramate (Qsymia), or naltrexone and bupropion (Contrave), along with a 12-week group therapy program focused on healthy eating and weight loss. The main goal is to see if this personalized approach can help with weight loss and if it's practical for people with bipolar disorder. This study is currently unclear on its recruitment status and plans to enroll 100 participants.
- Study design
- This is a single-site, open-label study, meaning both you and the study team will know which treatment you are receiving. It aims to enroll 100 participants.
- What's involved
- Participation lasts about 20 weeks and includes 8 in-person visits, up to 11 phone calls, and 13 virtual group therapy sessions.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, describing obesity phenotypes, is measured from enrollment through the end of the 20-week intervention.
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NCT07213466
Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
Recruiting
PHASE4Ages 18–65InterventionalTreatmentMayo ClinicInvestigator-initiated
~100 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:Group Therapy ProgramsemaglutidePhentermine-Topiramatenaltrexone and bupropion (combination)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Describe the distribution of obesity phenotypes (hungry brain, hungry gut, emotional hunger and slow burn) in patients with BD and obesity, with the goal of identifying predominant phenotype patterns within this clinical population.
Measured over From enrollment through the end of the 20-week intervention.
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Mark A Frye, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Men or women between 18 to 65 years old.
Patients with a SCID IV confirmed diagnosis of bipolar disorder (BDI or BDII) or schizoaffective bipolar type (SZA-BD).
Women with a negative pregnancy test 48 hours before study entry (obesity phenotyping visit).
Patients with a negative urine drug screen except for allowable drugs.
Patients with a BMI ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 plus one medical comorbidity (e.g., type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea)
Patients must be undergoing mood stabilizer treatment but may also receive concurrent antidepressant or anxiolytic therapy.
Patients must be on a stable regimen of a mood stabilizer, with no changes to the medication, for at least one month prior to study enrollment.
Continuation of mood-stabilizing treatment is preferred but not required; the decision should be made in collaboration with the participant's primary mental health provider.
Exclusion
Abdominal bariatric surgery: Gastric bypass surgery (Roux-en-Y), Adjustable gastric band (Lap band), and Gastric sleeve surgery (Sleeve gastrectomy).
Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, such as diabetic gastroparesis; or use of medications that may alter gastrointestinal motility and appetite.
Positive history of chronic gastrointestinal diseases that could affect gastrointestinal absorption such as inflammatory bowel disease (IBD), celiac disease, small intestinal bacterial overgrowth (SIBO), etc; or use of medications that may alter gastrointestinal absorption.
Significant untreated psychiatric dysfunction.
Hypersensitivity to any of the study medications.
Contraindications to the FDA-approved medications: Phentermine-Topiramate Extended Release; Oral naltrexone extended-release/bupropion extended-release (NBSR; Contrave®, Mysimba™); and Semaglutide (Weygovy™).
Inability to provide informed consent: participants who are on involuntary commitment, conservatorship or under a legal guardian.
Patients with active hypomania or mania (YMRS ≥ 20 points)
Patients with active psychosis (YMRS item 8 ≥ 6 points)
Patients with active suicide ideation (MADRS item 10 ≥ 4 points)
Patients with any medication changes (mood stabilizers) without advisement of study clinicians or clinical provider.
Patients with active bulimia (purging) or anorexia (severe restriction)
Patients with a history of bulimia (purging behaviors) or anorexia (severe dietary restriction) within the 12 months preceding study enrollment will be excluded
Current drug and/or alcohol use disorders (except nicotine)
Patients with a positive toxicology screening (except cannabis)
Positive toxicology screen for cannabis and a cannabis use disorder by CUDIT-R.
Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included in the study only if they take the CUDIT-R and score a 12 or less.
Patients unwilling to complete the full phenotyping day on its current form (i.e. patients avoiding gluten meal or adhering to a vegan diet).
What this trial measures
- Describe the distribution of obesity phenotypes (hungry brain, hungry gut, emotional hunger and slow burn) in patients with BD and obesity, with the goal of identifying predominant phenotype patterns within this clinical population.From enrollment through the end of the 20-week intervention.