Phase 4 Bipolar Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 65 years old.
• People who have been formally diagnosed with bipolar disorder (type I or II) or schizoaffective disorder, bipolar type, confirmed through a structured clinical interview (SCID IV).
• Women who have a negative pregnancy test taken within 48 hours before the first study visit.
• People whose drug screening results are negative, apart from any substances specifically permitted by the trial.
• People with a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher alongside at least one additional health condition such as type 2 diabetes, high blood pressure, high cholesterol, or sleep apnea.
• People who are currently taking a mood stabiliser medication, and who may also be taking antidepressants or anti-anxiety medications at the same time.
• People who have been on the same mood stabiliser medication, without any changes, for at least one month before joining the study.
• Continuing mood stabiliser treatment is preferred, but the decision is made together with the participant's own mental health provider and is not strictly required.

Who may not be able to join:

• People who have previously had weight-loss (bariatric) surgery, including gastric bypass, gastric banding, or gastric sleeve surgery.
• People with a history of ongoing digestive or gut conditions, or other health conditions that affect how the gut moves food through the body (such as diabetic gastroparesis), or who take medications that affect gut movement or appetite.
• People with a history of ongoing gut conditions that affect how the body absorbs nutrients — such as inflammatory bowel disease, coeliac disease, or small intestinal bacterial overgrowth — or who take medications that affect nutrient absorption.
• People with significant psychiatric symptoms that are currently not being treated.
• People who have a known allergic reaction or sensitivity to any of the study medications.
• People for whom any of the study medications are medically unsuitable — the medications involved are Phentermine-Topiramate Extended Release, Naltrexone/Bupropion Extended Release (Contrave® or Mysimba™), and Semaglutide (Wegovy™).
• People who are unable to give informed consent, including those under involuntary psychiatric commitment, conservatorship, or legal guardianship.
• People currently experiencing an active hypomanic or manic episode, as measured by a standard clinical rating scale (YMRS score of 20 or above).
• People currently experiencing active psychosis, as measured by a specific item on a clinical rating scale (YMRS item 8 score of 6 or above).
• People currently experiencing active thoughts of suicide, as measured by a specific item on a clinical rating scale (MADRS item 10 score of 4 or above).
• People who have made changes to their mood stabiliser medication without guidance from the study's clinical team or their own treating provider.
• People currently experiencing active bulimia (including purging behaviours) or anorexia (severe restriction of food intake).
• People who have had bulimia or anorexia within the 12 months before joining the study.
• People who currently have a drug or alcohol use disorder (not including nicotine).
• People whose drug screening test comes back positive (cannabis may be an exception — see below).
• People who use cannabis and test positive for it on a drug screen, and who also score above 12 on the CUDIT-R (a standardised cannabis use assessment tool), may not be eligible. Those who test positive for cannabis but score 12 or below on the CUDIT-R may potentially still be considered for inclusion (confirm with trial site).
• People who are unwilling or unable to complete the full assessment day in its current format — for example, those who avoid gluten or follow a strictly vegan diet.

Important: Always verify eligibility with the trial site directly before applying.