Depressive Disorder
Conditions
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
Interventions
DRUGFluoxetine 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
DRUGDapagliflozin 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
DRUGAtorvastatin 80mg
Atorvastatin is a synthetic and lipophilic statin, a class of drugs used in the treatment of hypercholesterolemia
Sponsors
Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • The primary endpoint is the change in Hamilton Rating Scale | 3 months | • The primary endpoint is the change in Hamilton Rating Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed