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

Tanta University

Status and phase: Completed; Phase 2

Conditions: Depressive Disorder

Treatments: Drug: Dapagliflozin 10mg Tab; Drug: Atorvastatin 80mg; Drug: Fluoxetine 20 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05792540

4/2023

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Control Group

Active Comparator group

Description:

Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months

Treatment:

Drug: Fluoxetine 20 mg

Dapagliflozin group

Active Comparator group

Description:

Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months

Treatment:

Drug: Fluoxetine 20 mg

Drug: Dapagliflozin 10mg Tab

Atorvastatin group

Active Comparator group

Description:

Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months

Treatment:

Drug: Fluoxetine 20 mg

Drug: Atorvastatin 80mg