Personalized weight-loss medication plan for adults with bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site, open-label, non-randomized pilot will enroll 100 adults with bipolar disorder and obesity and classify them into four obesity phenotypes: Hungry Brain, Hungry Gut, Emotional Hunger, and Slow Burn. Participants undergo detailed phenotyping including indirect calorimetry, gastric emptying testing, DEXA scans, ad libitum buffet meal testing, and behavioral questionnaires. Based on phenotype, participants receive semaglutide, phentermine-topiramate, or naltrexone-bupropion, while those with the Slow Burn phenotype receive behavioral and lifestyle interventions only. All participants take part in a 12-week virtual behavioral program and complete about 8 in-person visits over roughly 20 weeks to measure safety, tolerability, and weight change.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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).

Where it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Mark A Frye, M.D. — Mayo Clinic
• Study coordinator: Laura N Harper
• Email: harper.laura1@mayo.edu
• Phone: 507-255-9352

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.