RecruitingPhase 4NCT06707012

Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients


Sponsor

Fazaia Ruth Pfau Medical College

Enrollment

140 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy of metformin as an adjunct therapy in improving depressive symptoms and metabolic markers in newly diagnosed obese depressed patients on standard antidepressant therapy. investigator will compare between Two groups 1\. metformin group 2 placebo group Primary outcome measure will be the improvement in depressive symptoms, indicating by a reduction in Hamilton Depression Rating Scale (HAM-D) scores. Secondary outcome measures will include the assessment of oxidative stress markers, specifically by measuring the increase in enzymatic activity of superoxide dismutase, catalase, and glutathione peroxidase Investigators hypothesize that the addition of metformin to standard antidepressant treatment will result in a significant reduction in symptoms of depression among newly diagnosed obese individuals.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria5

  • • Age \>18 to \<45 years
  • Gender: Both genders (Male and Female)
  • BMI \>25
  • Diagnosis: Newly diagnose cases of depression (mild to severe)
  • HBA1C: Less than 5.7% (non-diabetic range)

Exclusion Criteria6

  • Existing diabetes
  • Acute illnesses like acute kidney injury, recent history of myocardial infarction, acute liver injury
  • Intellectual disabilities or inability to understand due to any reason
  • Presence of Psychiatric disorders other than depression
  • Chronic kidney disease (eGFR \< 45 mL/min/1.73 m²).
  • Use of any psychotropic medication within the past 6 months.

Interventions

DRUGMetformin Hydrochloride

Participants will be divided in 2 groups 1 group will receive metformin and 2nd group will receive placebo


Locations(2)

Fazaia Rurh Pfau Medical College

Karachi, Sindh, Pakistan

Fazaia Ruth Pfau Medical College

Karachi, Sindh, Pakistan

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NCT06707012


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