A Phase 4 interventional study of Dapagliflozin and Metformin in Antipsychotic-induced Weight Gain (AIWG) and Antipsychotic-induced Weight Gain, sponsored by Sultan Qaboos University. Not yet recruiting at 1 site in Oman. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Sultan Qaboos University · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to learn whether dapagliflozin can help manage weight gain caused by antipsychotic medications in people aged 16 years or older who are receiving antipsychotic treatment and have developed antipsychotic-induced weight gain.
The main questions it aims to answer are:
Can dapagliflozin reduce body weight as effectively and safely as metformin over the study period?
How do dapagliflozin and metformin compare in their effects on body weight, body mass index, waist circumference, blood sugar, HbA1c, lipid profile, psychiatric symptoms, quality of life, medication adherence, and side effects?
Researchers will compare dapagliflozin plus a common lifestyle program with metformin plus a common lifestyle program to see which treatment is more effective, better tolerated, and more acceptable for managing antipsychotic-induced weight gain.
Participants will:
Be randomly assigned to receive either dapagliflozin or metformin. Receive lifestyle advice, including dietary counselling, physical activity counselling, and behavioural support.
Attend clinic visits at baseline, Week 12, and Week 26 for weight, waist circumference, blood tests, medication review, and other assessments.
Receive telephone follow-up at Week 2, Week 6, and Week 18 to check medication adherence, side effects, tolerability, and lifestyle progress.
Complete questionnaires and clinical assessments related to physical activity, quality of life, psychiatric symptoms, and treatment tolerability.
This is an open-label, pragmatic, parallel-group pilot randomized controlled trial comparing dapagliflozin with metformin for the management of antipsychotic-induced weight gain. The study will be conducted at the Department of Behavioral Medicine, Sultan Qaboos University Hospital, University Medical City, Muscat, Oman.
Antipsychotic-induced weight gain is a common and clinically important adverse effect of antipsychotic treatment. It may contribute to reduced treatment adherence, poorer quality of life, and increased cardiometabolic risk. Metformin is commonly used to manage antipsychotic-associated weight gain, but its use may be limited by gastrointestinal adverse effects, dose titration, and pill burden. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has demonstrated weight-reducing and metabolic benefits in other clinical populations, but its role in antipsychotic-induced weight gain remains insufficiently studied.
Participants will be randomized in a 1:1 ratio to receive either dapagliflozin plus a common lifestyle program or metformin plus a common lifestyle program. The trial will use a pragmatic PROBE-style design, with open-label treatment allocation and blinded outcome assessment and statistical analysis where feasible. Randomization will use a computer-generated sequence with allocation concealment.
The study is designed as a pilot trial to assess feasibility, tolerability, adherence, safety, and preliminary estimates of treatment effect to inform a future definitive trial. Standardized procedures will be used for participant follow-up, medication review, safety monitoring, and data collection. Adverse events and treatment tolerability will be monitored throughout the study, and serious adverse events will be reported according to institutional and ethics committee procedures.
Data will be collected by trained study personnel and entered into an electronic database with procedures to support completeness and accuracy. Analyses will be primarily descriptive and exploratory, consistent with the pilot nature of the trial, and will be used to refine assumptions for a future larger randomized controlled trial.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's planned enrollment of 110 is above the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Sultan Qaboos University is the lead sponsor of 50 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Schizophrenia spectrum and other psychotic disorders, as summarized in the DSM-5 chapter Schizophrenia Spectrum and Other Psychotic Disorders, excluding:
Substance/medication-induced psychotic disorder Psychotic disorder due to another medical condition Catatonia associated with another mental disorder Catatonic disorder due to another medical condition Unspecified catatonia Bipolar and related disorders, as summarized in the DSM-5 chapter Bipolar and Related Disorders Depressive disorders, as summarized in the DSM-5 chapter Depressive Disorders Obsessive-compulsive and related disorders, as summarized in the DSM-5 chapter Obsessive-Compulsive and Related Disorders Other psychiatric conditions for which antipsychotic treatment is clinically indicated, as judged by the investigator Other conditions where antipsychotics are indicated
Evidence of antipsychotic-induced weight gain (AiWG), defined as:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Metformin · Other: Common Lifestyle Program
Drug: Dapagliflozin · Other: Common Lifestyle Program
Dapagliflozin will be administered orally at a dose of 10 mg once daily. Treatment will continue for 26 weeks. Participants will be monitored for adherence, tolerability, and adverse events, including genitourinary symptoms, dehydration, sick-day events, and symptoms suggestive of ketoacidosis.
Metformin will be administered orally. Participants will start with 500 mg twice daily, taken with meals, and will be titrated to 1000 mg twice daily by the second week as tolerated. Slower titration may be used if gastrointestinal side effects occur. Treatment will continue for the study period, with the primary endpoint assessed after 26 weeks at the maximum tolerated dose.
All participants will receive a standardized common lifestyle program. This will include dietary counselling, physical activity counselling, and behavioural support delivered at baseline and reinforced during scheduled in-person visits and telephone follow-up. Physical activity will be assessed using the International Physical Activity Questionnaire.
Change in Body Weight
Change in body weight from baseline to the primary endpoint. Body weight will be measured using standardized procedures and compared between the dapagliflozin plus common lifestyle program arm and the metformin plus common lifestyle program arm.
Time frame: Baseline, Week 12, and Week 26 at the maximum tolerated dose
Change in Body Mass Index (BMI)
Change in BMI (kg/m²) from baseline to week 26 to evaluate overall body composition changes associated with each intervention.
Time frame: Baseline, Week 12, and Week 26
Change in Waist Circumference
Change in waist circumference (measured at the midpoint between the lowest rib and iliac crest) from baseline to week 26, assessing central fat distribution.
Time frame: Baseline, Week 12, and Week 26
Change in Fasting Plasma Glucose
Difference in fasting plasma glucose levels from baseline to week 26, reflecting glucose metabolism and glycemic control.
Time frame: Baseline, Week 12, and Week 26
Change in Glycated Hemoglobin (HbA1c)
Change in HbA1c (%) from baseline to week 26, assessing long-term glucose regulation.
Time frame: Baseline, Week 12, and Week 26
Change in Lipid Profile
Change in total cholesterol, LDL, HDL, and triglycerides from baseline to week 26, evaluating metabolic health and cardiovascular risk.
Time frame: Baseline, Week 12, and Week 26
Change in psychiatric symptom severity
* Psychotic symptom severity will be assessed using the Brief Psychiatric Rating Scale, an 18-item clinician-rated scale. Total scores range from 18 to 126, with higher scores indicating greater psychotic symptom severity. * Depressive symptom severity will be assessed using the 17-item Hamilton Depression Rating Scale. Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity. * Manic symptom severity will be assessed using the Young Mania Rating Scale, an 11-item clinician-rated scale. Total scores range from 0 to 60, with higher scores indicating greater manic symptom severity. * Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale. Total scores range from 0 to 40, with higher scores indicating greater obsessive-compulsive symptom severity.
Time frame: Baseline, Week 12, and Week 26
Change in quality of life
Change in health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
Time frame: Baseline, Week 12, and Week 26
Medication adherence
Assessment of participant adherence to the assigned intervention during scheduled visits and telephone follow-up.
Time frame: Week 2, Week 6, Week 12, Week 18, and Week 26
Adverse events and tolerability
Frequency, severity, duration, action taken, and outcome of adverse events and tolerability issues reported during the study period.
Time frame: Week 2, Week 6, Week 12, Week 18, and Week 26
Physical activity assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Self-reported physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Physical activity will be measured to describe participant activity levels and to support adjustment for physical activity as a potential confounding variable in analyses of body weight and metabolic outcomes.
Time frame: Baseline, Week 12, and Week 26
Plan to share: Undecided
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapagliflozin
Sultan Qaboos University