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

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792540
• Other study ID #: 4/2023
• Status: Recruiting
• Phase: Phase 2
• Start date: June 6, 2023
• Est. completion date: March 20, 2025

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: Mostafa Bahaa, PhD
• Phone: 0201025538337
• Email: mbahaa[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 20, 2025
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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
• 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
• Atorvastatin 80mg
Atorvastatin is a synthetic and lipophilic statin, a class of drugs used in the treatment of hypercholesterolemia

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Menoufia University	Tanta	Shebeen El-Kom

Sponsors (4)

Lead Sponsor	Collaborator
Tanta University	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

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• The primary endpoint is the change in Hamilton Rating Scale	• The primary endpoint is the change in Hamilton Rating Scale	3 months
Secondary	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