Dapagliflozin in Depression

Phase 2RecruitingNCT07239011

Tanta University60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depression

Interventions

FluoxetineDRUG

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.

DapagliflozinDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Mostafa Bahaa

Damietta, New Damietta, Egypt

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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

Time frame: 3 months

Data from ClinicalTrials.gov

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