Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT05333003
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2022-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Structural MRI', 'timeFrame': '32 weeks', 'description': 'High-resolution anatomical image of the brain will be acquired'}, {'measure': 'Resting state functional MRI (rsfMRI)', 'timeFrame': '32 weeks', 'description': 'The resting-state echo-planar imaging will be used to analyze fronto-temporal network connectivity'}, {'measure': 'Arterial spin labeling (ASL)', 'timeFrame': '32 weeks', 'description': 'This scan will be performed to assess the effects on cerebral blood flow'}, {'measure': '1H-Magnetic resonance spectroscopy (MRS)', 'timeFrame': '32 weeks', 'description': 'A single voxel spectra will be acquired for a volume of interest placed over the bilateral striatum, to measure glutamate levels'}], 'primaryOutcomes': [{'measure': 'Weight change', 'timeFrame': '32 weeks', 'description': 'Percentage change in body weight (kg)'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': '32 weeks', 'description': "A person's weight in kilograms divided by height in metres squared"}, {'measure': 'Waist circumference', 'timeFrame': '32 weeks', 'description': 'Measured in centimetres'}, {'measure': 'Oral glucose tolerance test', 'timeFrame': '32 weeks', 'description': 'A standard glucose drink (75g) is given orally, and bloodwork containing insulin (pmol/L) and glucose (mmol/L) levels are obtained both at baseline and 2 hours after the glucose drink. These measures will help indicate B cell function and whole body insulin sensitivity, allowing for the proportion of individuals converting to impaired glucose tolerance, prediabetes, or type 2 diabetes to be determined.'}, {'measure': 'Visceral and hepatic adiposity', 'timeFrame': '32 weeks', 'description': 'An abdominal surface coil on the MRI will be used for this body composition measure'}, {'measure': 'Fasting lipid profile', 'timeFrame': '32 weeks', 'description': 'Cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglyceride levels will be collected through bloodwork in mmol/L'}, {'measure': 'Psychopathology - Brief Psychiatric Rating Scale (BPRS)', 'timeFrame': '32 weeks', 'description': 'Structured scale used to measure psychiatric symptoms'}, {'measure': 'Psychopathology - Calgary Depression Scale for Schizophrenia (CDSS)', 'timeFrame': '32 weeks', 'description': 'Structured scale used to measure depression in schizophrenia'}, {'measure': 'Psychopathology - Global Assessment of Functioning (GAF)', 'timeFrame': '32 weeks', 'description': 'Structured scale used to rate the global functioning of patient'}, {'measure': 'Psychopathology - Clinical Global Impression scale (CGI)', 'timeFrame': '32 weeks', 'description': 'Structured scale used to rate the global impression of patient'}, {'measure': 'Change in cognitive performance', 'timeFrame': '32 weeks', 'description': 'Evaluated through a standard scale called the MATRICS Consensus Cognitive Battery (MCCB)'}, {'measure': 'Lifestyle assessment - Assessment of Quality of life (AQoL)', 'timeFrame': '32 weeks', 'description': 'A structured scale used to measure health-related quality of life'}, {'measure': 'Lifestyle assessment - WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)', 'timeFrame': '32 weeks', 'description': 'A structured measure of health and disability'}, {'measure': 'Lifestyle assessment - International Physical Activity Questionnaire (IPAQ)', 'timeFrame': '32 weeks', 'description': 'A structured measure of physical activity practices'}, {'measure': 'Lifestyle assessment - The Fagerstrom Test of Nicotine Dependence (FTND)', 'timeFrame': '32 weeks', 'description': 'A structured scale used to measure the intensity of nicotine dependence related to cigarette smoking'}, {'measure': 'Lifestyle assessment - Penn State Nicotine Dependence Index-Cigarette/Electronic Cigarette', 'timeFrame': '32 weeks', 'description': 'A structured measure used to quantify the intensity of physical dependence across various nicotine products'}, {'measure': 'Lifestyle assessment - Canadian Diet History Questionnaire II (C-DHQ II)', 'timeFrame': '32 weeks', 'description': 'A structured, comprehensive questionnaire used to measure food frequency'}, {'measure': 'Lifestyle assessment - Food Cravings Questionnaire (FCQ)', 'timeFrame': '32 weeks', 'description': 'A structured item used to measure frequency and intensity of food cravings'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia spectrum disorders', 'GLP-1 receptor agonists', 'Weight', 'Antipsychotics'], 'conditions': ['Schizophrenia Spectrum Disorders']}, 'descriptionModule': {'briefSummary': 'Rates of obesity in patients with schizophrenia-spectrum disorder (SSD)s have reached epidemic proportions, with established contributing effects of antipsychotic (AP) medications. Among agents approved for chronic weight management, glucagon-like peptide-1 receptor agonists (GLP-1RA) are associated with reductions in cardiovascular mortality, with recent FDA approval for once weekly semaglutide for this indication. This study will investigate whether semaglutide is effective in reducing body weight in overweight or obese individuals with SSDs who are on APs and do not demonstrate adequate weight loss on metformin (the first line treatment for weight loss in SSDs).', 'detailedDescription': 'People with SSDs die early of iatrogenic cardiometabolic disease. Clinically, metformin remains the first line agent to mitigate this risk. In real-world clinical practice, metformin is likely to remain the first line treatment for AP-induced weight gain (given low cost, efficacy, and safety data). However, metformin is only effective in \\~20% of patients. Hence, there is a need for interventions for AP-induced weight gain non-responsive to metformin. GLP-1RAs might represent the next rational step as they have a good safety profile, advantages of weekly administration, and early efficacy evidence to support their use in SSD and comorbid obesity, with benefits on dysglycemia, and visceral adiposity. Semaglutide, recently approved for chronic weight loss is an attractive option given a similar adverse effect profile but superior metabolic efficacy compared to other GLP-1 agents. The observations supporting an association between metabolic perturbations and cognition, along with preliminary evidence for neuroprotective effects of GLP-1RAs, suggest that by modifying metabolic risk factors, the investigators may be able to target difficult-to-treat domains of the illness such as cognitive dysfunction.\n\nThis study will examine the effect of semaglutide on:\n\n1. Percentage change in body weight\n2. Measures of glucose metabolism and cardiovascular risk factors\n3. Psychopathology\n4. Cognition\n5. Lifestyle-based assessments'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* On maintenance treatment with an AP (stable dose for ≥3 months)\n* 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\n* 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)\n\nExclusion Criteria:\n\n* Patients with severe substance disorder other than tobacco or caffeine use disorder; only severe substance use disorder is exclusionary for cannabis use\n* Liver, or renal dysfunction\n* A positive drug urine screen other than cannabis as per PI discretion\n* Sexually active females of child-bearing age not on a regular contraceptive, or nursing or with a positive pregnancy test\n* Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, or pulmonary disease\n* History of reactive hypoglycaemia\n* Treatment within 3 months, or failure to tolerate GLP-1RA\n* Type 1 Diabetes (T1D) or current diagnosis of Type 2 Diabetes (T2D), diagnosis of T2D on OGTT screen, or HbA1c \\> 6.5%\n* Use of Health Canada approved weight-lowering agents, warfarin, coumarin derivatives, or medication with significant renal impact\n* Major medical or surgical event within the preceding 3 months\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome\n* History of pancreatitis or elevated amylase on screen\n* History of severe gastrointestinal disease, (i.e. gastroparesis)\n* Acute suicidal risk\n* Uncompensated thyroid disorder\n* History of heart rhythm disturbances, conduction system abnormalities, or evidence of clinically relevant abnormalities on screening ECG.\n* 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)\n* History of gallstones with intact gallbladder or those at increased risk of gallbladder complications (with intact gallbladder)'}, 'identificationModule': {'nctId': 'NCT05333003', 'acronym': 'Sema', 'briefTitle': 'Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity for Metformin Non-responders: a Single-blind Randomized Control Trial', 'orgStudyIdInfo': {'id': '139/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide', 'description': 'Semaglutide medication will be taken by participants on a weekly schedule, and adherence tracked', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be taken by participants on a weekly schedule, and adherence tracked', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': 'The semaglutide dose will start with 0.25 mg/week, and slowly increased every four weeks as tolerated up to a maximal dose of 2 mg/week', 'armGroupLabels': ['Semaglutide']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo will be provided to participants', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6J 1H4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Margaret Hahn, MD, PhD', 'role': 'CONTACT', 'email': 'margaret.hahn@camh.ca', 'phone': '416-535-8501', 'phoneExt': '34368'}], 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Margaret Hahn, MD, PhD', 'role': 'CONTACT', 'email': 'margaret.hahn@camh.ca', 'phone': '416-535-8501', 'phoneExt': '34368'}, {'name': 'Mahavir Agarwal, MD, PhD', 'role': 'CONTACT', 'email': 'mahavir.agarwal@camh.ca', 'phone': '416-535-8501', 'phoneExt': '30546'}], 'overallOfficials': [{'name': 'Margaret Hahn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Margaret Hahn', 'investigatorAffiliation': 'Centre for Addiction and Mental Health'}}}}