Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07213466
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Group Therapy Program — BEHAVIORAL
    a 12-week group therapy program centered around weight loss and healthy eating.
  • semaglutide — DRUG
    Brand name: Wegovy
  • Phentermine-Topiramate — DRUG
    Brand name: Qsymia
  • naltrexone and bupropion (combination) — DRUG
    Brand name: Contrave

Study Details

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.

Key Dates

Start date
Jan 19, 2026
Status verified
Mar 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide (Wegovy) + Group Therapy Program
    By meeting the satiety/return to hunger (Hungry Gut) phenotype, participants will take Semaglutide (Wegovy) and attend a 12-week group therapy session for the 16-week clinical trial.
  • Experimental: Naltrexone/Bupropion (Contrave) + Group Therapy Program
    By meeting the behavioral/psychological (Emotional Hunger) phenotype, participants will take Naltrexone/Bupropion (Contrave) and attend a 12-week group therapy session for the 16-week clinical trial.
  • Experimental: Phentermine/Topiramate (Qsymia) + Group Therapy Program
    By meeting the satiation (Hungry Brain) phenotype, participants will take Phentermine/Topiramate (Qsymia) and attend a 12-week group therapy session for the 16-week clinical trial.
  • Experimental: No Study Medication + Group Therapy Program
    By meeting the slow burn phenotype, participants will attend a 12-week group therapy session for the 16-week clinical trial.

Primary Outcome Measure

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. [ Time Frame: From enrollment through the end of the 20-week intervention. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Laura N Harper
[email protected]
507-255-9352
Mark A Frye, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Bipolar disorderObesity / overweight
By specialty
PsychiatryMental healthBehavioral healthEndocrinologyMetabolic healthWeight loss
By research site
Mayo Clinic· Rochester, MN

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