Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders

Phase 2

Completed

• Conditions: Depressive Disorder
• Interventions: Drug: Fluoxetine 20 mg; Drug: Dapagliflozin 10mg Tab; Drug: Atorvastatin 80mg

• Registration Number: NCT05792540
• Lead Sponsor: Tanta University

Brief Summary

Major depressive disorder (MDD) is a significant cause of disability that affects approximately 16% of the world's population and is associated with chronic inflammation. Although the mechanisms of MDD have not yet been clearly elucidated, NLRP3 inflammasomes have been implicated in the pathogenesis of depression.NLRP3 inflammasome is an intracellular multiprotein complex that consists of nod-like receptor protein 3, an adaptor protein, and a procaspase-1 precursor. It is well known that a variety of danger signals, such as pathogen-associated molecular patterns and danger-associated molecular patterns can activate NLRP3 inflammasome

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-19
• Study First Submitted QC: 2023-03-19
• Study First Posted: 2023-03-31
• Study Start: 2023-06-06
• Primary Completion: 2024-11-20
• Status Verified: 2024-12
• Study Completion: 2024-12-20
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

• Patients with bipolar I or bipolar II disorder
• Patients with personality disorders
• Patients with eating disorders
• Patients with substance dependence or abuse
• Patients with concurrent active medical conditions
• Patients with a history of seizures
• Patients with a history of receiving Electroconvulsive therapy (ECT)
• Patients with inflammatory disorders
• Patients with allergies or contraindications to the used medications
• Patients with finally pregnant or lactating females
• Diabetic or hyperlipidaemic patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Fluoxetine 20 mg	Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months
Dapagliflozin group	Fluoxetine 20 mg	Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
Dapagliflozin group	Dapagliflozin 10mg Tab	Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
Atorvastatin group	Fluoxetine 20 mg	Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months
Atorvastatin group	Atorvastatin 80mg	Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months

Primary Outcome Measures

Name	Time	Method
• The primary endpoint is the change in Hamilton Rating Scale	3 months	• The primary endpoint is the change in Hamilton Rating Scale

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint is estimated by changes in serum biomarkers.	3 months	The secondary endpoint is estimated by changes in serum biomarkers such as F) Nuclear factor erythroid 2-related factor 2

Trial Locations

Locations (1)

Faculty of Medicine, Menoufia University; 🇪🇬 Tanta, Shebeen El-Kom, Egypt