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Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder

Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder - OBOE-Mayo

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 11 visits, 5 visits
  • Time periods mentioned: 20 weeks, 7 months
  • Procedures mentioned: Phone or video check-ins, Blood draws, Heart tracing (ECG), Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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)."
  • "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."
  • "Participants will undergo comprehensive obesity phenotyping, including indirect calorimetry, gastric emptying scintigraphy, DEXA scans, ad libitum buffet meal testing, and validated behavioral questionnaires."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether hunger and eating patterns can help guide the choice of weight-loss medicine. It is for adults ages 18–65 with obesity, or excess weight and a related health problem, who have bipolar disorder or schizoaffective disorder, bipolar type. Some people may receive no study medicine, but everyone will join online group therapy for weight loss.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–65 years old.
  • Have bipolar I, bipolar II, or schizoaffective disorder, bipolar type, confirmed by a study interview.
  • Have a BMI of 30 or higher, or 27 or higher with a health problem such as diabetes, high blood pressure, abnormal blood fats, or breathing pauses during sleep. BMI is a measure of weight compared with height.
  • Be taking a mood-stabilizing medicine, with no changes for at least one month before joining. Medicines for depression or anxiety are also allowed.
  • Continuing mood-stabilizing medicine is preferred but not required. This decision should be made with your main mental health provider.
  • Women must have a negative pregnancy test 48 hours before the study's hunger and eating-pattern testing visit.
  • Have a negative urine drug test, except for drugs the study allows.

Who can't join

  • Have had weight-loss surgery, such as gastric bypass, a stomach band, or gastric sleeve surgery.
  • Have a long-term digestive illness, another illness, or take medicines that affect how food moves through the gut, how nutrients are absorbed, or appetite.
  • Have a serious untreated mental health problem, current high or overactive mood episodes, loss of touch with reality, or thoughts of suicide that meet the study's rating limits.
  • Have an allergy or another medical reason you cannot take a study medicine, or change mood-stabilizing medicine without guidance from a study clinician or your care provider.
  • Cannot give informed consent, including being under forced mental health care, a conservatorship, or a legal guardian.
  • Have bulimia (purging after eating) or anorexia (severely limiting food) now or within the past 12 months.
  • Have a current drug or alcohol use disorder, except nicotine, or a positive drug test other than cannabis. A positive cannabis test may be allowed only with a score of 12 or less on the study's cannabis-use questionnaire.
  • Are unwilling to complete the full day of hunger and eating-pattern tests as planned, including the meals. This may include avoiding gluten or following a vegan diet.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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).

Study sites (1)

MN