Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Decrease scoring of Hamilton depression rating scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This will be double blind study in which participant and investigator who prescribe the drug will be blind
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age >18 to <45 years
- •Gender: Both genders (Male and Female)
- •Diagnosis: Newly diagnose cases of depression (mild to severe)
- •HBA1C: Less than 5.7% (non-diabetic range)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Metformin Hydrochloride (Drug)
placebo group
Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
Decrease scoring of Hamilton depression rating scale
时间窗: 18 months
Primary outcome measure will be the improvement in depressive symptoms, indicating by a change in Hamilton Depression Rating Scale (HAM-D) scores. Decrease in the score will be considered as indicator of improvement in depression. 0-7: Normal (no depression) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23 and above: Very severe depression Investigators will compare the change in both groups.
次要结局
- elevation in oxidative enzymes level (superoxide dismutase,catalase,glutathione peroxidase(18 months)
研究者
Sadia khan
Dr. Sadia Khan MBBS resident FCPS Pharmacology
Fazaia Ruth Pfau Medical College