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 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT05333003
Eligibility Criteria:
Inclusion Criteria:
* Stable outpatients or inpatients aged 18-70 years, diagnosed with schizophrenia spectrum disorder, or major depressive disorder with psychotic features, or bipolar disorder (does not need to have psychotic features)
* On maintenance treatment with an AP (stable dose for ≥3 months)
* BMI must be ≥30 kg/m2, OR ≥27 kg/m2 with the presence of at least one weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnea, or impaired fasting glucose, OR BMI ≥25 with individual having gained \>5% bodyweight in association with AP treatment
* History of either failure to tolerate metformin or failure to lose ≥5% body weight over at least 16 weeks on the highest tolerated trial of metformin, and who are not currently being treated with metformin (minimum of 1 week metformin-free prior to study entry)
Exclusion Criteria:
* Patients with severe substance disorder other than tobacco or caffeine use disorder; only severe substance use disorder is exclusionary for cannabis use
* Liver, or renal dysfunction
* A positive drug urine screen other than cannabis as per PI discretion
* Sexually active females of child-bearing age not on a regular contraceptive, or nursing or with a positive pregnancy test
* Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, or pulmonary disease
* History of reactive hypoglycaemia
* Treatment within 3 months, or failure to tolerate GLP-1RA
* Type 1 Diabetes (T1D) or current diagnosis of Type 2 Diabetes (T2D), diagnosis of T2D on OGTT screen, or HbA1c \> 6.5%
* Use of Health Canada approved weight-lowering agents, warfarin, coumarin derivatives, or medication with significant renal impact
* Major medical or surgical event within the preceding 3 months
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome
* History of pancreatitis or elevated amylase on screen
* History of severe gastrointestinal disease, (i.e. gastroparesis)
* Acute suicidal risk
* Uncompensated thyroid disorder
* History of heart rhythm disturbances, conduction system abnormalities, or evidence of clinically relevant abnormalities on screening ECG.
* Any condition that interferes with the safe acquisition of MRI data such as metal implants, pacemakers, aneurysm clips, cochlear implants (only for the MRI component; can participate in the remainder of the trial)
* History of gallstones with intact gallbladder or those at increased risk of gallbladder complications (with intact gallbladder)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05333003
Study Brief:
Protocol Section:
NCT05333003