Dapagliflozin in Depression

Tanta University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Depression

Treatments: Drug: Fluoxetine; Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT07239011

8759

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Fluoxetine

Dapagliflozin group

Active Comparator group

Description:

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

Treatment:

Drug: Dapagliflozin

Drug: Fluoxetine