Using metformin to enhance antidepressant treatment in obese patients with depression
Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
PHASE4 · Fazaia Ruth Pfau Medical College · NCT06707012
This study is testing if adding metformin to the usual antidepressant treatment can help obese patients with depression feel better.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Fazaia Ruth Pfau Medical College (other) |
| Locations | 2 sites (Karachi, Sindh and 1 other locations) |
| Trial ID | NCT06707012 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of metformin as an additional treatment for improving depressive symptoms in newly diagnosed obese patients already receiving standard antidepressant therapy. Participants will be randomly assigned to either a metformin group or a placebo group, with the primary outcome being the reduction in Hamilton Depression Rating Scale (HAM-D) scores. Secondary outcomes will assess oxidative stress markers through enzymatic activity measurements. The study aims to determine if metformin can significantly enhance the treatment of depression in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 45 with a BMI over 25 and a recent diagnosis of depression.
Not a fit: Patients with existing diabetes or other significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for obese patients suffering from depression.
How similar studies have performed: While the combination of metformin and antidepressants is a novel approach, similar studies have shown promise in addressing metabolic issues in depressed patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Karachi, Sindh and 1 other locations
- Fazaia Rurh Pfau Medical College — Karachi, Sindh, Pakistan (RECRUITING)
- Fazaia Ruth Pfau Medical College — Karachi, Sindh, Pakistan (RECRUITING)
Study contacts
- Principal investigator: sadia khan, MBBS — Fazaia Ruth Pfau Medical College
- Study coordinator: Sadia khan, MBBS
- Email: sadiakhansk30@gmail.com
- Phone: 0331359046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, oxidative stress, antidepressants, obesity