NCT06707012RecruitingPhase 4
Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- 1 Oct 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Fazaia Ruth Pfau Medical College
- Diseases
- Obesity
- NCT number
- NCT06707012
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 140
- From 1 Oct 2025 to the primary completion date, 30 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- • 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)
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fazaia Rurh Pfau Medical College Coordinator of this site? Confirm its status | Karachi | Pakistan | Recruiting |
| Fazaia Ruth Pfau Medical College Coordinator of this site? Confirm its status | Karachi | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.