Comparative Effectiveness of Dapagliflozin, Metformin, and Lifestyle Modification for Antipsychotic-Induced Weight Gain: An Open-Label Pragmatic Trial
NCT ID: NCT07342764
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2026-04-30
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The goal of this clinical trial is to learn if dapagliflozin can help reduce weight gain caused by antipsychotic medications in people with schizophrenia and related disorders. It will also assess the safety of dapagliflozin.
* The main questions it aims to answer are:
* Does dapagliflozin lower body weight compared to metformin or lifestyle changes alone?
* Does it improve blood sugar, cholesterol, and overall health?
* Researchers will compare three groups:
* Dapagliflozin plus lifestyle changes
* Metformin plus lifestyle changes
* Lifestyle changes alone
* Participants will:
* Take the assigned medication daily for 26 weeks (or follow lifestyle guidance only)
* Attend clinic visits at weeks 0, 4, 12, and 26 for measurements and blood tests
* Receive phone calls for follow-up and side effect checks
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Atypical Antipsychotic and Valproate Combination Therapy on Glucose and Lipid Metabolism in Schizophrenia
NCT00552500
Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain
NCT00451399
Does GLP-1RA Prevent Deterioration of Metabolic State in Prediabetic and Diabetic Patients Treated With Antipsychotic Medication?
NCT04892199
Does a GLP-1 Receptor Agonist Change Glucose Tolerance in Antipsychotic-treated Patients?
NCT01845259
Metformin for Weight Loss in Schizophrenia
NCT01177709
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
3 Researchers will compare three different approaches to see which works best to help with antipsychotic-related weight gain:
* Metformin plus lifestyle changes (diet and exercise guidance)
* Dapagliflozin plus lifestyle changes
* Lifestyle changes alone
\# The main question the study aims to answer is:
* Does dapagliflozin help people lose more weight or prevent further weight gain compared to lifestyle changes alone or metformin?
\# Other questions include:
* How do these approaches affect blood sugar, cholesterol, and overall health?
* How well do participants tolerate dapagliflozin compared to metformin?
* Do these treatments improve quality of life and treatment satisfaction?
* Study Design This is a 26-week randomized controlled trial taking place at Sultan Qaboos University Hospital in Muscat, Oman.
Participants will be randomly assigned to one of the three groups above. Neither the participants nor their doctors will be blinded, but the researchers who measure results and analyze the data will not know which group participants are in, to keep the results fair.
Who Can Take Part
People aged 16 years or older who:
* Have a schizophrenia-spectrum disorder (as defined in DSM-5)
* Are taking one antipsychotic medicine and have been stable for at least 3 months
* Have gained 7% or more of their body weight since starting the medication, or have a BMI over 25 kg/m²
People cannot join if they:
* Have diabetes, kidney, or liver disease
* Are pregnant or breastfeeding
* Have recently used weight-loss medications
* Have unstable mental illness or substance use that affects study participation
What Participants Will Do All participants will receive lifestyle guidance, including diet, exercise, and behavioral support.
In addition:
* One group will take metformin tablets twice daily
* One group will take dapagliflozin once daily
* One group will make lifestyle changes only
Participants will:
* Visit the clinic at the start, and again at weeks 4, 12, and 26
* Receive phone calls at weeks 2, 8, and 18 to check on progress and side effects
* Have blood tests and measurements (weight, waist, glucose, cholesterol)
* Fill out questionnaires about physical activity, mood, and quality of life
What the Study Will Measure
* Main outcome: Change in body weight after 26 weeks
* Other outcomes:
BMI and waist circumference Blood sugar, insulin, and cholesterol levels Percentage of people losing 5% or more of their weight Psychiatric symptom scores and quality of life Any side effects or treatment satisfaction
Why This Research Matters Many people who take antipsychotics struggle with weight gain, which can harm their health and make them stop treatment. Dapagliflozin is already used for diabetes and helps the body remove extra sugar through urine, which may also help reduce weight gain. However, no study has yet tested dapagliflozin specifically for antipsychotic-induced weight gain.
This research could identify a new, safe, and effective way to manage this problem, helping people stay healthy and continue their psychiatric treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
Metformin (1000 mg Twice a day)
Metformin tablets starting at 500 mg twice daily and increased to 1000 mg twice daily as tolerated, taken with meals for 26 weeks.
Lifestyle Modification Program
Participants receive a structured lifestyle program, including dietary counseling, physical-activity planning, and behavioral support at scheduled visits (weeks 0, 4, 12, and 26).
Arm B
Dapagliflozin 10 mg
Dapagliflozin 10 mg tablet taken once daily for 26 weeks. It increases glucose excretion through urine and may lower weight.
Lifestyle Modification Program
Participants receive a structured lifestyle program, including dietary counseling, physical-activity planning, and behavioral support at scheduled visits (weeks 0, 4, 12, and 26).
Arm C
Control
Lifestyle Modification Program
Participants receive a structured lifestyle program, including dietary counseling, physical-activity planning, and behavioral support at scheduled visits (weeks 0, 4, 12, and 26).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metformin (1000 mg Twice a day)
Metformin tablets starting at 500 mg twice daily and increased to 1000 mg twice daily as tolerated, taken with meals for 26 weeks.
Dapagliflozin 10 mg
Dapagliflozin 10 mg tablet taken once daily for 26 weeks. It increases glucose excretion through urine and may lower weight.
Lifestyle Modification Program
Participants receive a structured lifestyle program, including dietary counseling, physical-activity planning, and behavioral support at scheduled visits (weeks 0, 4, 12, and 26).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of a schizophrenia spectrum or other psychotic disorder according to DSM-5 (excluding substance/medication-induced or medical-condition-related psychoses, catatonia due to another disorder, or unspecified catatonia).
* On stable antipsychotic monotherapy for at least 3 months before enrollment.
* Evidence of antipsychotic-induced weight gain, defined as:
* ≥7% increase in body weight from pre-treatment baseline, or
* Body Mass Index (BMI) \>25 kg/m² with documented antipsychotic-related weight gain.
* Stable psychiatric symptoms, judged clinically able to give informed consent and participate in the study.
Exclusion Criteria
* Renal impairment (estimated glomerular filtration rate \<45 mL/min/1.73 m²), hepatic disease, or other serious medical illness.
* Pregnancy or breastfeeding.
* Use of weight-loss medications or programs within the past 3 months.
* Known hypersensitivity to metformin or dapagliflozin.
* Unstable psychiatric condition or active substance use disorder likely to interfere with adherence or follow-up.
16 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sultan Qaboos University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohammed Al Alawi MD PhD MRCPsych ARABpsych OMSBpsych
Consultant and Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mohammed Al Alawi, MD, PhD
Role: STUDY_CHAIR
Sultan Qaboos University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SQU
Muscat, , Oman
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Ferreira-Hermosillo A, Molina-Ayala MA, Molina-Guerrero D, Garrido-Mendoza AP, Ramirez-Renteria C, Mendoza-Zubieta V, Espinosa E, Mercado M. Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial. Trials. 2020 Feb 14;21(1):186. doi: 10.1186/s13063-020-4121-x.
Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29.
Bolinder J, Ljunggren O, Kullberg J, Johansson L, Wilding J, Langkilde AM, Sugg J, Parikh S. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012 Mar;97(3):1020-31. doi: 10.1210/jc.2011-2260. Epub 2012 Jan 11.
Mansuri Z, Makani R, Trivedi C, Adnan M, Vadukapuram R, Rafael J, Lodhi A, Reddy A. The role of metformin in treatment of weight gain associated with atypical antipsychotic treatment in children and adolescents: A systematic review and meta-analysis of randomized controlled trials. Front Psychiatry. 2022 Nov 15;13:933570. doi: 10.3389/fpsyt.2022.933570. eCollection 2022.
Hegde NC, Mishra A, Maiti R, Mishra BR, Mohapatra D, Srinivasan A. Pharmacological interventions for antipsychotic-induced weight gain in schizophrenia: A network meta-analysis. Gen Hosp Psychiatry. 2024 Sep-Oct;90:12-21. doi: 10.1016/j.genhosppsych.2024.06.003. Epub 2024 Jun 11.
de Silva VA, Suraweera C, Ratnatunga SS, Dayabandara M, Wanniarachchi N, Hanwella R. Metformin in prevention and treatment of antipsychotic induced weight gain: a systematic review and meta-analysis. BMC Psychiatry. 2016 Oct 3;16(1):341. doi: 10.1186/s12888-016-1049-5.
Dayabandara M, Hanwella R, Ratnatunga S, Seneviratne S, Suraweera C, de Silva VA. Antipsychotic-associated weight gain: management strategies and impact on treatment adherence. Neuropsychiatr Dis Treat. 2017 Aug 22;13:2231-2241. doi: 10.2147/NDT.S113099. eCollection 2017.
Musil R, Obermeier M, Russ P, Hamerle M. Weight gain and antipsychotics: a drug safety review. Expert Opin Drug Saf. 2015 Jan;14(1):73-96. doi: 10.1517/14740338.2015.974549. Epub 2014 Nov 15.
Barton BB, Segger F, Fischer K, Obermeier M, Musil R. Update on weight-gain caused by antipsychotics: a systematic review and meta-analysis. Expert Opin Drug Saf. 2020 Mar;19(3):295-314. doi: 10.1080/14740338.2020.1713091. Epub 2020 Mar 12.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AIWG2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.