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

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 - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064215

Enrollment

Registered

2024-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Metformin: Group A - Metformin 500 mg BD after meals for 12 weeks Control Intervention1: Metformin & Fluoxetine: Group B – Metformin 500 mg BD after meals + Fluoxetine 40 mg OD for 12

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Efficacy of Metformin versus Metformin Fluoxetine in patients of Type 2 Diabetes Mellitus with Mild DepressionTimepoint: Week 0,2,4,6,8,10,12	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDeepali Aggarwal

Government Medical College

kullar.g@gmail.com9501009338

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026