Metformin added to antidepressants for depression with obesity in Pakistani adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In people with depression and obesity, researchers will compare add-on metformin plus standard antidepressant therapy to antidepressant therapy alone. The study will also look at how NEGR1 and RPL31P12 genetic variants may influence response to the combination versus antidepressant-only treatment. Participants are adults 18 and older with recurrent depression, who are overweight or obese by Asian standards, and meet inclusion criteria related to mood symptoms and stable or recent antidepressant history. The study is conducted at two sites in Rawalpindi, Pakistan, led by Riphah International University. Results could help tailor treatments based on genetics and metabolic status.

Why it matters

Who can join: the full rules

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

Where it's running

• Pakistan Railway Hospital
  Rawalpindi, Punjab Province, Pakistan Recruiting
• Afifa Siddique
  Rawalpindi, Punjab Province, Pakistan Recruiting

Study contacts

• Principal investigator: Afifa,Siddique, PhD Scholar, MBBS, M.Phil — Islamic International Medical College, Riphah International University
• Study coordinator: Afifa Siddique, PhD Scholar, MBBS, M.Phil
• Email: dr.afifa.siddique@gmail.com
• Phone: +923175441910

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mindfulness‑augmented brain stimulation for treatment‑resistant depression

  This trial will test whether combining fast brain stimulation (iTBS) with a digital mindfulness program helps people with treatment‑resistant depression reduce symptoms and improve thinking.

  Recruiting Phase 2 University of California, San Diego · San Diego, California · NCT07512284

• Oh Happy Day Class – Digital Connections for Depression in African Americans

  A mobile app delivers six weekly depression-therapy classes to African American adults to see if it helps reduce depressive symptoms.

  Recruiting University of Wisconsin, Madison · Madison, Wisconsin · NCT06206226

• Step-by-step care plan to improve treatment for moderate depression in general practice

  It tests whether a structured step-by-step care plan used by general practitioners works better than usual GP care or psychologist-led behavioral therapy for adults 18–65 with moderate depression.

  Recruiting Aalborg University Hospital · Aalborg · NCT07263321

• Developing a gamified app to help 8–12-year-olds with depression manage everyday stressors

  This project will ask children ages 8–12 with increased depressive symptoms and their parents about daily stressors and coping to help design a gamified app that tries to teach emotion regulation.

  Recruiting Ludwig-Maximilians - University of Munich · München, Bavaria · NCT07159347

• Predicting depression in patients after heart surgery

  This study is trying to see if a new tool can help predict which patients might develop depression after heart surgery, so they can get help sooner.

  Recruiting University of Zurich · Zurich and 1 other locations · NCT06706323

• Mobile app for treating depression in cancer survivors

  This study tests if a mobile app called 'Moodivate' can help cancer survivors who are feeling depressed feel better over 12 weeks.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT06582784

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.