Dapagliflozin in Depression

NCT07239011 | Recruiting Phase 1

• 1 other identifier: 8759
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in quality of life.

  3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Control group (n =30) who will receive fluoxetine (20 mg) and placebo once daily for 3 months

Drug: Fluoxetine

Dapagliflozin group

ACTIVE COMPARATOR

Dapagliflozin group (n=30) who will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months

Drug: Fluoxetine; Drug: Dapagliflozin

Interventions

Fluoxetine DRUG

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.

Control group; Dapagliflozin group

Dapagliflozin DRUG

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.

Dapagliflozin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Mostafa Bahaa

Damietta, New Damietta, 34518, Egypt

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Fluoxetine; dapagliflozin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

EG (1)