Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT07213466
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 ≥ 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07213466
Study Brief:
Protocol Section:
NCT07213466