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

Study Overview
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Brief Summary
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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

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

Conditions
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Depressive Disorder

Intervention / Treatment
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* Drug: Fluoxetine 20 mg
* Drug: Dapagliflozin 10mg Tab
* Drug: Atorvastatin 80mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months | Drug: Fluoxetine 20 mg<br>* 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<br>|
| Active Comparator: Dapagliflozin group<br>Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months | Drug: Fluoxetine 20 mg<br>* 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<br>Drug: Dapagliflozin 10mg Tab<br>* 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<br>|
| Active Comparator: Atorvastatin group<br>Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months | Drug: Fluoxetine 20 mg<br>* 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<br>Drug: Atorvastatin 80mg<br>* Atorvastatin is a synthetic and lipophilic statin, a class of drugs used in the treatment of hypercholesterolemia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • The primary endpoint is the change in Hamilton Rating Scale | • The primary endpoint is the change in Hamilton Rating Scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months |