Dapagliflozin in Depression

Dapagliflozin, an SGLT2 Inhibitor, From Oral Hypoglycemic Agent to Antidepressant Drug

Major depressive disorder (MDD) is currently one of the leading causes of disability and suicidal death worldwide, and despite extensive research and massive improvements in mental health, the nature of MDD remains ambiguous. Moreover, about two-thirds of MDD patients fail to optimally respond to currently available standard therapies, and many of them suffer from treatment-resistant depression

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Drug: Fluoxetine; Drug: Dapagliflozin

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • New Damietta
    • Damietta, New Damietta, Egypt, 34518
      • Recruiting
      • Mostafa Bahaa
      • Contact: Mostafa Bahaa, PhD; Phone Number: 0201025538337; Email: mbahaa@horus.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with Hamilton rating score more than 18.

Exclusion Criteria:

Patients with bipolar I or bipolar II disorder, personality disorders, and eating disorders.

Patients with substance dependence or abuse Patients with history of seizures or receiving electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females Diabetic patients Sever kidney disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Control group (n =30) who will receive fluoxetine (20 mg) and placebo once daily for 3 months	Drug: Fluoxetine; Fluoxetine is an antidepressant medication of the selective serotonin reuptake inhibitor class used for the treatment of major depressive disorder, anxiety, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, and bulimia nervosa.
Active Comparator: Dapagliflozin group; Dapagliflozin group (n=30) who will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months	Drug: Fluoxetine; Fluoxetine is an antidepressant medication of the selective serotonin reuptake inhibitor class used for the treatment of major depressive disorder, anxiety, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, and bulimia nervosa.; Drug: Dapagliflozin; Dapagliflozin is a medication used to treat type 2 diabetes. It is also used to treat adults with heart failure and chronic kidney disease. It reversibly inhibits sodium-glucose co-transporter 2 (SGLT-2) in the renal proximal convoluted tubule to reduce glucose reabsorption and increase urinary glucose excretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure was the 17-item HDRS.	All patients will be assessed via Hamilton Depression Rating Scale (HDRS). A HDRS score of ≤ 7 indicates remission or partial remission [HDRS<17 and>7]. Response was defined as ≥ 50% drop in the HDRS score.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life.	Change in quality of life will be assessed through Short Form-36 Health Survey. One of the most commonly used quality of life tools. It consists of 36 items, and 8 domains	3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Estimated): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Organic Chemicals; Amines; Propylamines; Fluoxetine; dapagliflozin
• Other Study ID Numbers: 8759

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No