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Completed

NCT Number: NCT05792540

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

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

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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Menoufia University

Tanta, Shebeen El-Kom, 32511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. • 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

  1. The secondary endpoint is estimated by changes in serum biomarkers.

    Time frame: 3 months

    The secondary endpoint is estimated by changes in serum biomarkers such as F) Nuclear factor erythroid 2-related factor 2

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2023
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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