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

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

Study Overview

• Status: Completed
• Conditions: Depressive Disorder
• Intervention / Treatment: Drug: Fluoxetine 20 mg; Drug: Dapagliflozin 10mg Tab; Drug: Atorvastatin 80mg

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Shebeen El-Kom
    • Tanta, Shebeen El-Kom, Egypt, 32511
      • Faculty of Medicine, Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months	Drug: Fluoxetine 20 mg; Fluoxetine is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It's often used to treat depression, and sometimes obsessive-compulsive disorder and bulimia. It works by increasing the levels of serotonin in the brain
Active Comparator: Dapagliflozin group; Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months	Drug: Fluoxetine 20 mg; Fluoxetine is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It's often used to treat depression, and sometimes obsessive-compulsive disorder and bulimia. It works by increasing the levels of serotonin in the brain; Drug: Dapagliflozin 10mg Tab; Dapagliflozin (DAPA), a sodium-glucose co-transporter 2 inhibitor (SGLT2-I), has proven to be an effective hyperglycemic suppressor due to its role in inhibiting the reabsorption of 30-50% of the glucose filtered by the kidney, besides its role in the improvement of insulin resistance
Active Comparator: Atorvastatin group; Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months	Drug: Fluoxetine 20 mg; Fluoxetine is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It's often used to treat depression, and sometimes obsessive-compulsive disorder and bulimia. It works by increasing the levels of serotonin in the brain; Drug: Atorvastatin 80mg; Atorvastatin is a synthetic and lipophilic statin, a class of drugs used in the treatment of hypercholesterolemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• The primary endpoint is the change in Hamilton Rating Scale	• The primary endpoint is the change in Hamilton Rating Scale	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University; Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta University; Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): November 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: March 19, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Enzyme Inhibitors; Antimetabolites; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Cytochrome P-450 Enzyme Inhibitors; Neurotransmitter Uptake Inhibitors; Antidepressive Agents; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Dapagliflozin; Fluoxetine
• Other Study ID Numbers: 4/2023

Drug and device information, study documents

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