Back to resultsClinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders
Primary Purpose
Depressive Disorder
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Fluoxetine 20 mg
Dapagliflozin 10mg Tab
Atorvastatin 80mg
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Menoufia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control Group
Dapagliflozin group
Atorvastatin group
Arm Description
Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months
Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months
Outcomes
Primary Outcome Measures
• The primary endpoint is the change in Hamilton Rating Scale
• The primary endpoint is the change in Hamilton Rating Scale
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05792540
First Posted
March 19, 2023
Last Updated
June 6, 2023
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
1. Study Identification
Unique Protocol Identification Number
NCT05792540
Brief Title
Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders
Official Title
Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
March 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months
Arm Title
Dapagliflozin group
Arm Type
Active Comparator
Arm Description
Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
Arm Title
Atorvastatin group
Arm Type
Active Comparator
Arm Description
Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Fluoxetine 20 mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10mg Tab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 80mg
Intervention Description
Atorvastatin is a synthetic and lipophilic statin, a class of drugs used in the treatment of hypercholesterolemia
Primary Outcome Measure Information:
Title
• The primary endpoint is the change in Hamilton Rating Scale
Description
• The primary endpoint is the change in Hamilton Rating Scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The secondary endpoint is estimated by changes in serum biomarkers.
Description
The secondary endpoint is estimated by changes in serum biomarkers such as F) Nuclear factor erythroid 2-related factor 2
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg
Facility Information:
Facility Name
Faculty of Medicine, Menoufia University
City
Tanta
State/Province
Shebeen El-Kom
ZIP/Postal Code
32511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manal A Hamouda, PhD
Phone
0201067009096
Email
manal.hamouda@phrm.menofia.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders
We'll reach out to this number within 24 hrs