Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
NCT ID: NCT07213466
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2025-12-01
2028-01-01
Brief Summary
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* 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 17-18 weeks and includes 7 in-person study visits, 4 phone call visits, and 12 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, 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 (Qysmia®). 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 16 weeks (4 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 16-week visits). Every two weeks in between in-person visits, the study team will call participants to assess medication adherence. Participants will be compensated for time spent in this study.
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Detailed Description
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Participants will undergo comprehensive obesity phenotyping, including indirect calorimetry, gastric emptying scintigraphy, DEXA scans, ad libitum buffet meal testing, and validated behavioral questionnaires. Based on phenotype classification, participants will receive one of the following FDA-approved anti-obesity medications (AOMs): phentermine-topiramate ER (Qsymia®), semaglutide (Wegovy®), or naltrexone-bupropion ER (Contrave®). Participants with the Slow Burn phenotype will receive behavioral and lifestyle interventions only.
All participants will engage in a 12-week virtual behavioral intervention program led by a multidisciplinary team, including a psychologist and a registered dietitian. The program includes weekly group sessions focused on nutrition, physical activity, cognitive restructuring, and relapse prevention.
A comprehensive data safety monitoring plan (DSMP) is in place, including bi-monthly reviews by a multidisciplinary team. Adverse events (AEs) and serious adverse events (SAEs) will be monitored and reported per institutional and federal guidelines. Participants will be withdrawn from the study if they experience treatment-emergent mania, severe depression, suicidality, or other safety concerns.
The statistical analysis plan includes descriptive statistics, repeated measures models, and subgroup analyses by phenotype and BD subtype. Missing data will be handled using multiple imputation or maximum likelihood methods. No formal multiplicity adjustments will be applied due to the exploratory nature of the study.
This study addresses a critical gap in obesity treatment for individuals with serious mental illness by integrating precision medicine with psychiatric care. The findings will inform future randomized controlled trials and contribute to the development of personalized obesity interventions in psychiatric populations.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Group Therapy Program
a 12-week group therapy program centered around weight loss and healthy eating.
semaglutide
Brand name: Wegovy
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.
Group Therapy Program
a 12-week group therapy program centered around weight loss and healthy eating.
naltrexone and bupropion (combination)
Brand name: Contrave
Phentermine/Topiramate (Qysmia) + Group Therapy Program
By meeting the satiation (Hungry Brain) phenotype, participants will take Phentermine/Topiramate (Qysmia) and attend a 12-week group therapy session for the 16-week clinical trial.
Group Therapy Program
a 12-week group therapy program centered around weight loss and healthy eating.
Phentermine-Topiramate
Brand name: Qsymia
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.
Group Therapy Program
a 12-week group therapy program centered around weight loss and healthy eating.
Interventions
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Group Therapy Program
a 12-week group therapy program centered around weight loss and healthy eating.
semaglutide
Brand name: Wegovy
Phentermine-Topiramate
Brand name: Qsymia
naltrexone and bupropion (combination)
Brand name: Contrave
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 ≥ 12 points)
* Patients with active severe depression (MADRS ≥ 30 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)
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University of Toronto
OTHER
Mayo Clinic
OTHER
Responsible Party
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Mark Frye
Principal Investigator
Principal Investigators
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Mark A Frye, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25-005856
Identifier Type: -
Identifier Source: org_study_id
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