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New treatment option for Bipolar I Disorder
Official title Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
ClinicalTrials.gov ID: NCT07213466
What this study is testing
What is semaglutide?
semaglutide is an investigational medicine, given as an once-weekly, being studied as a potential treatment for bipolar i disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)?
- Phase 4: studies an already-approved treatment
- Time commitment: about 7 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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...
- Positive history of chronic gastrointestinal diseases that could affect gastrointestinal absorption such as inflammatory bowel disease (IBD), celiac...
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 7 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.