METFORMIN AS ADJUNCT THERAPY AND ITS CORRELATION WITH SERUM BDNF LEVELS AND BRAIN NEUROMETABOLITES IN ESCITALOPRAM TREATED MAJOR DEPRESSIVE DISORDER PATIENTS- A 1H-MRS STUDY

Central Institute of Psychiatry1 个研究点分布在 1 个国家目标入组 44 人开始时间: 2026年3月10日最近更新: 2026年2月27日

试验速览

阶段: 3 期
状态: 尚未招募
发起方: Central Institute of Psychiatry
入组人数: 44
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is randomized, parallel group active control study comparing the effectiveness of metformin 1000mg as adjunct to escitalopram in comparison to escitalopram alone in 44 patients both outpatient and inpatient basis at central institute of psychiatry, Ranchi. Primary outcome would be improvement of scores on depressive symptoms and cognitive function tests measured at baseline, 2 and 6 weeks. secondary outcome would be improvement in metabolic parameters, alterations in neurometabolite concentrations and improvement in serum BDNF levels measured at baseline, 2 and 6 weeks

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: Participant Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Patients diagnosed with Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (Text Revision), DSM-5-TR Diagnostic criteria.
•Patients receiving treatment for MDD with stable dose of 20 mg Escitalopram both on inpatient and outpatient basis.
•Those who give Informed Consent for participating in the study.

排除标准

•Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine.
•Major physical illness (uncontrolled Epilepsy, Myocardial Infarction, Uncontrolled Hypertension, Renal Insufficiency, Liver Failure), Metabolic disorders (Diabetes mellitus, Hyperlipidaemia) or any Neurological disorders.
•Pregnant and Lactating Women.
•Known Hypersensitivity to Metformin.
•Patient receiving treatment with any other psychotropic medications except Benzodiazepines.
•Not willing to give Written Informed Consent.

研究者

发起方

Central Institute of Psychiatry

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Dr Jeevana Sai

CENTRAL INSTITUTE OF PSYCHIATRY

研究点 (1)

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