Could a diabetes drug boost antidepressants for weight and mood?
NCT ID NCT07654179
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This study tests whether adding the diabetes drug metformin to standard antidepressants helps people with both depression and obesity lose weight and feel better. Researchers will also check if certain gene variants affect how well the combination works. The trial involves 200 adults in Pakistan and lasts up to 3 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin (added to antidepressant therapy)
- What this could lead to
- If successful, adding metformin to antidepressants could become a simple, low-cost way to improve both mood and weight in people with depression and obesity.
- What could go wrong
- This is a small, early-stage study (200 people) with no placebo control, so results may not be conclusive. Genetic findings may not apply to other populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA Group I: Normal Controls Group II: Depression Group III: Obesity Group IV and V: * Age ≥ 18 years * Both males and females * Recurrent depressive disorder (6A71) according to ICD-11, * Asian cut off: Obese and overweight (BMI \< 23) * BDI score ≥ 13 or PHQ score ≥ 4 * Either medication-naïve or medication-free for at least 2 weeks before enrollment, or the patient did not take antidepressants during the last 7 days before study entry (discontinuation of effective medication to enable study participation is prohibited) * In case of non-psychotropic medication: The patient received stable pharmacological medication for at least 14 days before study entry (any changes in medication dose or frequency of therapy must be answered with no) EXCLUSION CRITERIA Groups I-III: Negative Controls (Normal: no depression and Obesity for SNP comparison only) * Age less than 18 * Dementia/ Mentally impaired who can not fill self report performas for inclusion criteria Group IV: Positive Control (RCT patients) * Patients with comorbid conditions (HTN, CKD) if taking any drug for that condition. * The patient is not an employee of the investigator study site, or a family member of the employees or the investigator, or otherwise dependent on the sponsor, the investigator, or the investigator study site. * The patient did not participate in other interventional trials during the 6 months before and at the time of this trial. The patient does not have a history of non-response to antidepressants included in the study. * The patient has not given birth within the 6 months before study entry and is not breastfeeding * The patient did not receive treatment with ketamine, irreversible MAO inhibitor (e.g. tranylcypromine), electroconvulsive therapy (ECT) or other stimulatory treatments in the index episode. * The patient is not diagnosed with dementia and does not have moderate or severe impairment of general cognitive function according to clinical impression. * The patient does not meet the criteria for alcohol use disorder (DSM-5: 303.90; ICD-10: F10.20) or substance use disorder (DSM-5: 304; ICD-10: F11.20 - F19.20) in DSM-5, and a urine/serum drug screening is negative (except for benzodiazepines and opiates). * The patient does not have: * A known allergy or contraindication against antidepressants included in the study * History of suicidal tendencies * Uncontrolled hepatic disorder, renal or cardiovascular disease * DM * Untreated hypothyroidism * History of myocardial infarction or stroke * Symptomatic peripheral arterial disease * Monogenic familial hypercholesterolemia
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Afifa Siddique
RECRUITINGRawalpindi, Punjab Province, Pakistan
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Pakistan Railway Hospital
RECRUITINGRawalpindi, Punjab Province, 44000, Pakistan
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