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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Metformin Hydrochloride
  Participants will be divided in 2 groups 1 group will receive metformin and 2nd group will receive placebo

Первичные конечные точки

• Decrease scoring of Hamilton depression rating scale [Срок оценки: 18 months]

Вторичные конечные точки (1)

• elevation in oxidative enzymes level (superoxide dismutase,catalase,glutathione peroxidase [Срок оценки: 18 months]

Критерии участия

Критерии включения

• • 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 2 центра

• Fazaia Rurh Pfau Medical College — Karachi
• Fazaia Ruth Pfau Medical College — Karachi

Публикации

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• 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. PMID 31748286
• 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. PMID 17017829
• 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. PMID 26402520
• 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. PMID 20194822
• 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. PMID 9526970
• 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. PMID 23147210
• 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. PMID 32346286

Идентификаторы

NCT: NCT06707012 · frpmc.edu.pk@sadiakhan12345678 · FMC, University

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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