Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
NCT ID: NCT06707012
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
140 participants
INTERVENTIONAL
2025-10-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
Setting:
At psychiatric Out Patient Department of Fazaia Ruth Pfau Medical College and Hospital Karachi Pakistan
Study Duration:
18 months
TREATMENT
DOUBLE
Study Groups
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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.
Metformin Hydrochloride
Participants will be divided in 2 groups
1 group will receive metformin and 2nd group will receive placebo
placebo group
Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression
Metformin Hydrochloride
Participants will be divided in 2 groups
1 group will receive metformin and 2nd group will receive placebo
Interventions
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Metformin Hydrochloride
Participants will be divided in 2 groups
1 group will receive metformin and 2nd group will receive placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
No
Sponsors
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Fazaia Ruth Pfau Medical College
OTHER
Responsible Party
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Sadia khan
Dr. Sadia Khan MBBS resident FCPS Pharmacology
Principal Investigators
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sadia khan, MBBS
Role: PRINCIPAL_INVESTIGATOR
Fazaia Ruth Pfau Medical College
Locations
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Fazaia Rurh Pfau Medical College
Karachi, Sindh, Pakistan
Fazaia Ruth Pfau Medical College
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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Guo M, Mi J, Jiang QM, Xu JM, Tang YY, Tian G, Wang B. Metformin may produce antidepressant effects through improvement of cognitive function among depressed patients with diabetes mellitus. Clin Exp Pharmacol Physiol. 2014 Sep;41(9):650-6. doi: 10.1111/1440-1681.12265.
Farooq S, Khan T, Zaheer S, Shafique K. Prevalence of anxiety and depressive symptoms and their association with multimorbidity and demographic factors: a community-based, cross-sectional survey in Karachi, Pakistan. BMJ Open. 2019 Nov 19;9(11):e029315. doi: 10.1136/bmjopen-2019-029315.
Heiskanen TH, Niskanen LK, Hintikka JJ, Koivumaa-Honkanen HT, Honkalampi KM, Haatainen KM, Viinamaki HT. Metabolic syndrome and depression: a cross-sectional analysis. J Clin Psychiatry. 2006 Sep;67(9):1422-7. doi: 10.4088/jcp.v67n0913.
Lang UE, Beglinger C, Schweinfurth N, Walter M, Borgwardt S. Nutritional aspects of depression. Cell Physiol Biochem. 2015;37(3):1029-43. doi: 10.1159/000430229. Epub 2015 Sep 25.
Luppino FS, de Wit LM, Bouvy PF, Stijnen T, Cuijpers P, Penninx BW, Zitman FG. Overweight, obesity, and depression: a systematic review and meta-analysis of longitudinal studies. Arch Gen Psychiatry. 2010 Mar;67(3):220-9. doi: 10.1001/archgenpsychiatry.2010.2.
Lee A, Morley JE. Metformin decreases food consumption and induces weight loss in subjects with obesity with type II non-insulin-dependent diabetes. Obes Res. 1998 Jan;6(1):47-53. doi: 10.1002/j.1550-8528.1998.tb00314.x.
Seifarth C, Schehler B, Schneider HJ. Effectiveness of metformin on weight loss in non-diabetic individuals with obesity. Exp Clin Endocrinol Diabetes. 2013 Jan;121(1):27-31. doi: 10.1055/s-0032-1327734. Epub 2012 Nov 12.
AlHussain F, AlRuthia Y, Al-Mandeel H, Bellahwal A, Alharbi F, Almogbel Y, Awwad O, Dala'een R, Alharbi FA. Metformin Improves the Depression Symptoms of Women with Polycystic Ovary Syndrome in a Lifestyle Modification Program. Patient Prefer Adherence. 2020 Apr 15;14:737-746. doi: 10.2147/PPA.S244273. eCollection 2020.
Calkin CV, Chengappa KNR, Cairns K, Cookey J, Gannon J, Alda M, O'Donovan C, Reardon C, Sanches M, Ruzickova M. Treating Insulin Resistance With Metformin as a Strategy to Improve Clinical Outcomes in Treatment-Resistant Bipolar Depression (the TRIO-BD Study): A Randomized, Quadruple-Masked, Placebo-Controlled Clinical Trial. J Clin Psychiatry. 2022 Feb 1;83(2):21m14022. doi: 10.4088/JCP.21m14022.
Jitca G, Gall Z, Jitca CM, But MG, Majai E. Drug Repurposing of Metformin for the Treatment of Haloperidol-Related Behavior Disorders and Oxidative Stress: A Preliminary Study. Pharmaceutics. 2024 Mar 15;16(3):403. doi: 10.3390/pharmaceutics16030403.
Other Identifiers
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FMC, University
Identifier Type: OTHER
Identifier Source: secondary_id
frpmc.edu.pk@sadiakhan12345678
Identifier Type: -
Identifier Source: org_study_id
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