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CTRI Number  CTRI/2024/03/064215 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Test and compare how effective and safe it is to use Metformin alone versus using both Metformin and Fluoxetine randomly in treating people who have Type 2 Diabetes and have mild depression 
Scientific Title of Study   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 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepali Aggarwal 
Designation  Junior Resident  
Affiliation  Government Medical College 
Address  Department of Pharmacology Government Medical College, Circular Road, Medical Enclave Amritsar

Amritsar
PUNJAB
143001
India 
Phone  9888046612  
Fax    
Email  deepaliaggarwal1238@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gurpreet Kaur Randhawa 
Designation  Professor & Head of Department  
Affiliation  Government Medical College 
Address  Department of Pharmacology Government Medical College, Circular Road, Medical Enclave Amritsar

Amritsar
PUNJAB
143001
India 
Phone  9501009338  
Fax    
Email  kullar.g@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deepali Aggarwal 
Designation  Junior Resident  
Affiliation  Government Medical College 
Address  Department of Pharmacology Government Medical College, Circular Road, Medical Enclave Amritsar


PUNJAB
143001
India 
Phone  9888046612  
Fax    
Email  deepaliaggarwal1238@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College, Circular road, Amritsar 
 
Primary Sponsor  
Name  Not Available 
Address  Not Available 
Type of Sponsor  Other [Not Available] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepali Aggarwal  Government Medical College, Amritsar  Department of Pharmacology and Department of Medicine
Amritsar
PUNJAB 		 9888046612

deepaliaggarwal1238@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee Govt. Medical College Amritsar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Metformin  Group A - Metformin 500 mg BD after meals for 12 weeks  
Comparator Agent  Metformin & Fluoxetine  Group B – Metformin 500 mg BD after meals + Fluoxetine 40 mg OD for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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-11.
Patients between the ages of 18-65 years of both sexes.
Patients willing to join the study after giving the informed consent 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Metformin versus Metformin Fluoxetine in patients of Type 2 Diabetes Mellitus with Mild
Depression 		 Week 0,2,4,6,8,10,12 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   24/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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. 

 
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