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

September 18, 2025 updated by: Sadia khan, Fazaia Ruth Pfau Medical College

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a comparative clinical study with randomized groups. Participants will be allocated to either the metformin group or the placebo group in conjunction with standard antidepressant therapy. Randomization will be achieved using computer generated numbers in 1:1 ratio.

Metformin Group: Starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines.

Placebo Group: Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression.

Study will take place at psychiatric Out Patient Department of Fazaia Ruth Pfau Medical College and Hospital Karachi Pakistan

Investigators will recruit participants from the psychiatric outpatient department of PAF Hospital diagnosed with depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition for at least 2 weeks and having obesity. depression is assessed with help of Hamilton Depression Scale (HAM-D). Participants whose score is above 8 and will meet the inclusion criteria will be added in study.

Informed consent:

Participants who meets the criteria will be asked for written informed consent form and explain in detail about the study

Base Line Data Collection After taking informed consent, detailed history, physical examination, HbA1c and serum creatinine will be measured. Participants whose HbA1c results is below 5.7% and creatinine clearance is above 30% will be selected in the study. Investigators will assess HbA1c, serum creatinine levels at every 12 weeks' interval. Serum levels of antioxidant enzymes (superoxide dismutase, catalase, glutathione peroxidase) will measured in participants by using biochemical assays at baseline and at the end of the study.

Follow up visits Participants will be followed up six times throughout the study duration. 1st follow up visit will occur at 4th week to evaluate the response to treatment by using Hamilton depression rating scale for depression, as according to Maudsley guidelines initial response to treatment should be assessed within 4 weeks. Next follow ups will take place at every 6th week till 36 weeks to assess improvement in depression and changes in BMI.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75120
        • Recruiting
        • Fazaia Rurh Pfau Medical College
        • Contact:
        • Contact:
        • Principal Investigator:
          • sadia khan, MBBS
        • Sub-Investigator:
          • Asghar Mehdi, MBBS,PHD
        • Sub-Investigator:
          • Tooba Riaz, MBBS
        • Sub-Investigator:
          • Asad Afridi, MBBS,PHD
        • Sub-Investigator:
          • Natasha Billia, MBBS,PHD
      • Karachi, Sindh, Pakistan, 75120
        • Recruiting
        • Fazaia Ruth Pfau Medical College
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Asad Afridi, MBBS,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
We will prescribe metformin with starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines.
Drug: Metformin Hydrochloride

Participants will be divided in 2 groups

1 group will receive metformin and 2nd group will receive placebo

Other Names:
  • GLUCOPHAGE
Placebo Comparator: placebo group
Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression
Drug: Metformin Hydrochloride

Participants will be divided in 2 groups

1 group will receive metformin and 2nd group will receive placebo

Other Names:
  • GLUCOPHAGE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease scoring of Hamilton depression rating scale
Time Frame: 18 months

Primary outcome measure will be the improvement in depressive symptoms, indicating by a change in Hamilton Depression Rating Scale (HAM-D) scores. Decrease in the score will be considered as indicator of improvement in depression.

0-7: Normal (no depression) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23 and above: Very severe depression Investigators will compare the change in both groups.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
elevation in oxidative enzymes level (superoxide dismutase,catalase,glutathione peroxidase
Time Frame: 18 months

Secondary outcome measures will include the change in oxidative stress markers, specifically by measuring the enzymatic activity of superoxide dismutase, catalase, and glutathione peroxidase. Increase in levels of enzymes will be considered as indicator of improvement of depression.

investigators will compare the change in both groups.
18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Basal Metabolic Rate
Time Frame: 18 months
weight in kilograms and height in meters of the participants will be assessed at each follow up visit to identify change in basal metabolic rate and will compare between groups
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fazaia Ruth Pfau Medical College

Investigators

  • Principal Investigator: sadia khan, MBBS, Fazaia Ruth Pfau Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • frpmc.edu.pk@sadiakhan12345678
  • FMC, University (Other Identifier: AIR UNIVERSITY)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared if required by authority

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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