Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders
Overview
- Phase
- Phase 2
- Intervention
- Fluoxetine 20 mg
- Conditions
- Depressive Disorder
- Sponsor
- Tanta University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- • The primary endpoint is the change in Hamilton Rating Scale
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Mostafa Bahaa
Teaching Assistant
Tanta University
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
Arms & Interventions
Control Group
Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months
Intervention: Fluoxetine 20 mg
Dapagliflozin group
Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
Intervention: Fluoxetine 20 mg
Dapagliflozin group
Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
Intervention: Dapagliflozin 10mg Tab
Atorvastatin group
Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months
Intervention: Fluoxetine 20 mg
Atorvastatin group
Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months
Intervention: Atorvastatin 80mg
Outcomes
Primary Outcomes
• The primary endpoint is the change in Hamilton Rating Scale
Time Frame: 3 months
• The primary endpoint is the change in Hamilton Rating Scale
Secondary Outcomes
- The secondary endpoint is estimated by changes in serum biomarkers.(3 months)