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

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05792540

Collaborator

Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University (Other), Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta University (Other), Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University (Other)

Enrollment

Location

Arms

23.8

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder	Drug: Fluoxetine 20 mg Drug: Dapagliflozin 10mg Tab Drug: Atorvastatin 80mg	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

double-blind

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 28, 2023

Anticipated Primary Completion Date :

Mar 20, 2024

Anticipated Study Completion Date :

Mar 20, 2025

Arms and Interventions

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

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

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

Drug: Atorvastatin 80mg

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

Outcome Measures

Primary Outcome Measures

• 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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.