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Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder

Study acronym: OBOE-Mayo
StatusRecruiting
PhasePhase 4
Started2026-01-19
View on ClinicalTrials.gov ↗

Amendment history

2026-03-06
notable
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-12-01→2028-02-01
Completion date2028-01-01→2029-02-01
Start dateestimated 2025-12-01→confirmed 2026-01-19
Eligibility criteria+277 characters
[...] l guardian. Patients with active hypomania or mania (YMRS ≥ 1220 points) Patients with active severe depression (MADRS ≥ 30 points) Patients with active psychosis (YMRS item 8 ≥ 6 points) Pati [...] 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) [...] study only if they take the CUDIT-R and score a 12 or less. Patients unwilling to complete t [...]
Secondary endpoints7 entries, revised
To evaluateCompare the feasibilitydistribution of anti-obesity medicationphenotypes (AOMhungry brain, hungry gut, emotional hunger, and slow burn) in patients with BD and obesity and non-BD participants published in previously cohorts. ToThe evaluatefeasibility theand tolerability of anti-obesity medication (AOM) in patients with BD. To, evaluateassessed changesby inadherence mitochondrialrates and stress-relatedreports biomarkerson adverse events. Total body weight loss (e.g.,in MMPP metabolites and GDF15kilograms) from baseline to end point in patients with BD. To assess total body weight lo [...] [...]
Primary endpoints1 entry, revised
CompareDescribe the distribution of obesity phenotypes (hungry brain, hungry gut, emotional hunger and slow burn) betweenin patients with BD patients and non-BDobesity, participantswith (IRBthe #24-002375)goal of identifying predominant phenotype patterns within this clinical population.
Study sitesdetails revised at 1 of 1 site
2025-11-24
minor
Study Status v1
Primary completion date2027-10-22→2027-12-01
Start date2025-10-22→2025-12-01
2025-10-01
minor
Original filing
1,015 trials monitored
See 115 trials at risk
3,523 trials monitored
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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.
Trial Details
NCT Number NCT07213466
Lead Sponsor Mayo Clinic
Collaborators: University of Toronto
Conditions Bipolar I Disorder, Bipolar II Disorder, Schizo Affective Disorder, Obesity, Weight Loss, GLP - 1
Enrollment 100 participants
Start Date 2026-01-19
Primary Completion 2028-02-01 (estimated)
Study Completion 2029-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-11