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 depressio

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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 a; 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of Metformin versus Metformin Fluoxetine in patients of Type 2 Diabetes Mellitus with Mild <br/ ><br>DepressionTimepoint: Week 0,2,4,6,8,10,12

Secondary Outcome Measures

Name	Time	Method
To analyse the Safety of the Drugs.Timepoint: Weeks - 2,4,6,8,10,12;To assess the Quality of LifeTimepoint: Weeks - 2,4,6,8,10,12;To check the Compliance of study DrugsTimepoint: Weeks - 2,4,6,8,10,12