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临床试验/CTRI/2024/03/064215
CTRI/2024/03/064215尚未招募4 期

A Prospective, Randomized And Open Label Study To Compare The Efficacy And Safety Of Metformin Versus Metformin And Fluoxetine In Patients Of Type 2 Diabetes Mellitus With Mild Depression

Not Available1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月24日最近更新:
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试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Depression
研究概览研究设计入排标准结局指标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 is a Prospective, Randomized And Open Label Study wherein we Compare The Efficacy And Safety Of Metformin Versus Metformin And Fluoxetine In Patients Of Type 2 Diabetes Mellitus With Mild Depression.

The study protocol has been already approved by the Institutional Scientific Committee and Ethics Committee. The study recruitment will start on 18/03/2024.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)（—）
性别
All

入选标准

  • •Diagnosed cases of T2DM HbA1c ≥ 6.5%.
  • •FPG ≥ 126 mg/dl (7.0 mmol/l) after 8 hours of Fasting.
  • •2-hour plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT.
  • •In a patient with classic symptoms of hyperglycemia, a random plasma glucose ≥200 mg/dl (11.1 mmol/l).
  • •Diagnosed cases of concomitant Mild Depression according to ICD-
  • •Patients between the ages of 18-65 years of both sexes.
  • •Patients willing to join the study after giving the informed consent.

排除标准

  • •Patients with Type 1 DM, Diabetes Insipidus, Acromegaly, Cushing’s Syndrome, Thyrotoxicosis, Anaemia in Pregnancy, and Haemoglobinopathies. Patients with any Organic cause of Depression. Any other Psychiatric comorbidities. Any other comorbidities like Cardiovascular, Renal and Hepatic diseases. Special Physiological conditions like Pregnancy and Lactation. Patients using drugs that can induce Diabetes: Corticosteroids, Thiazides, Phenytoin, Beta Blockers, Antipsychotics, Statins. Patients using drugs that can cause Depression: Corticosteroids; Benzodiazepines – Alprazolam, Clonazepam, Chlordiazepoxide, Diazepam, Flurazepam, Lorazepam, Triazolam; Anticonvulsants – Ethosuximide; Beta Adrenergic Blockers – Metoprolol, Atenolol, Carvedilol; Interferon α; Opiods – Codeine, Meperidine, Morphine, Oxycodone; Statins – Atorvastatin, Fluvastatin, Pravastatin, Simvastatin. Patients using drugs that may interact with Metformin.
  • •Acetazolamide, Methazolamide, Dichlorphenamide, Topiramate, Zonisamide, Patients using drugs that may interact with Fluoxetine.
  • •Antidepressants.
  • •Monoamine Oxidase Inhibitors (MAOI), Selective Serotonin Reuptake Inhibitors (SSRIs), Tricyclic Antidepressants (TCAs); Pimozide; Thioridazone; Tamoxifen; Calcium Channel Blockers; Cyproheptadine; Amino Acids L-Dopa and L-Tryptophan; Anorexiants.
  • •Fenfluramine, Anticonvulsants – Carbamazapine, Phenytoin; and Anxiolytics – Alprazolam, Buspirone, Diazepam.

结局指标

主要结局

Depression

时间窗: Week 0,2,4,6,8,10,12

Efficacy of Metformin versus Metformin Fluoxetine in patients of Type 2 Diabetes Mellitus with Mild

时间窗: Week 0,2,4,6,8,10,12

次要结局

  • To analyse the Safety of the Drugs.(Weeks - 2,4,6,8,10,12)
  • To assess the Quality of Life(Weeks - 2,4,6,8,10,12)
  • To check the Compliance of study Drugs(Weeks - 2,4,6,8,10,12)

研究者

发起方
Not Available
申办方类型
Other [Not Available]
责任方
Principal Investigator
主要研究者

Deepali Aggarwal

Government Medical College

研究点 (1)

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