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

NCT05792540 | Completed Phase 2

• 1 other identifier: 4/2023
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• • The primary endpoint is the change in Hamilton Rating Scale

  • The primary endpoint is the change in Hamilton Rating Scale

  3 months

Secondary Outcomes (1)

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

  3 months

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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

Drug: Fluoxetine 20 mg

Dapagliflozin group

ACTIVE COMPARATOR

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

Drug: Fluoxetine 20 mg; Drug: Dapagliflozin 10mg Tab

Atorvastatin group

ACTIVE COMPARATOR

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

Drug: Fluoxetine 20 mg; Drug: Atorvastatin 80mg

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

Atorvastatin group; Control Group; Dapagliflozin group

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

Dapagliflozin group

Atorvastatin 80mg DRUG

Atorvastatin is a synthetic and lipophilic statin, a class of drugs used in the treatment of hypercholesterolemia

Atorvastatin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead
• Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University: collaborator

Study Sites (1)

Faculty of Medicine, Menoufia University

Tanta, Shebeen El-Kom, 32511, Egypt

Location

Related Publications (1)

• Aldossary KM, Ali LS, Abdallah MS, Bahaa MM, Elmasry TA, Elberri EI, Kotkata FA, El Sabaa RM, Elmorsi YM, Kamel MM, Negm WA, Elberri AI, Hamouda AO, AlRasheed HA, Salahuddin MM, Yasser M, Hamouda MA. Effect of a high dose atorvastatin as added-on therapy on symptoms and serum AMPK/NLRP3 inflammasome and IL-6/STAT3 axes in patients with major depressive disorder: randomized controlled clinical study. Front Pharmacol. 2024 May 24;15:1381523. doi: 10.3389/fphar.2024.1381523. eCollection 2024.

  PMID: 38855751 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

Fluoxetine; dapagliflozin; Atorvastatin

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: March 31, 2023
• Study Start: June 6, 2023
• Primary Completion: November 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 3, 2025

Record last verified: 2024-12

Locations

EG (1)