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

Sponsor
Tanta University
Study ID
NCT05792540
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluoxetine 20 mg — DRUG
    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 — DRUG
    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 — DRUG
    Atorvastatin is a synthetic and lipophilic statin, a class of drugs used in the treatment of hypercholesterolemia

Study Details

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

Key Dates

Start date
Jun 6, 2023
Status verified
Dec 2024
Primary completion
Nov 20, 2024
Completion
Dec 20, 2024

Study Design

Enrollment
75 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Group
    Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months
  • Active Comparator: Dapagliflozin group
    Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months
  • Active Comparator: Atorvastatin group
    Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months

Primary Outcome Measure

• The primary endpoint is the change in Hamilton Rating Scale [ Time Frame: 3 months ]

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