Efficacy of Statins Among Major Depressive Disorder

NCT06698666 | Recruiting Phase 3

• 1 other identifier: 187/2022
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if drug Rosuvastatin 10 mg works to treat MDD in adults. It will also learn about the safety of Rosuvastatin 10 mg .The main questions it aims to answer are: Does Rusovastatin lower the score of The Montgomery Asberg Depression Rating Scale (MADRS) among adult participants with Major Depression Disorder ( MDD )? What medical problems do participants have when taking drug ABC? Participants will: Take Rosuvastatin 10 mg every day for 3 months Visit the clinic once every 4 weeks for checkups and tests Report any side effects for Rosuvastatin 10 mg and reassess the severity of depression using The Montgomery Asberg Depression Rating Scale (MADRS)

Conditions

Major Depressive Disorder; MDD

Keywords

Rosuvastatin; Major depressive disorder; MADRS scale

Outcome Measures

Primary Outcomes (1)

• Severity of depression among Participants with MDD as Assessed by MADRS scale

  Severity of depression will be determined using the Montgomery Asberg Depression Rating Scale (MADRS) including those who are between 7 and 34. * The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy. * Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. * The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts * Time: Interviews take 20 to 60 minutes to complete.

  3 months (12 weeks)

Study Arms (2)

The Control Group

OTHER

The Control Group will receive the standard treatment of depression including SSRI (Sertraline) only

The Interventional group

EXPERIMENTAL

the interventional group will receive the standard treatment of depression including SSRI (Sertraline) in addition to the10 mg/day rosuvastatin

Interventions

Rosuvastatin 10 mg tablet. DRUG

The dose of rosuvastatin was derived from literature describing the doses at which the agents' targeted actions are effective and safe. The 10- mg rosuvastatin dose reflects the lowest prescribed therapeutic dose A serum cholesterol level will be drawn from the whole participants and sent to the central laboratories of El-Demerdash hospital at baseline and at week 12. At each visit, participants will be requested to return all unused investigational products. Adherence to medication will be assessed by a pill count.

Sertraline Pill DRUG

Both control and intervention group will receive the sertraline as a standard therapy

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged between 20 and 45 years;
• diagnosis of current MDD, verified using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P);
• The Montgomery Asberg Depression Rating Scale (MADRS) score of 7 to 34, indicating mild to moderate depression;
• the ability to give informed consent and to comply with standard procedures;
• Males and females; and
• Stable pharmacological treatment for at least 2 weeks prior to enrolment (changes to medication dose or frequency of therapy excepted) if currently being treated.

You may not qualify if:

• lifetime or current SCID-I/P diagnosis of a psychotic disorder;
• lifetime SCID-I/P diagnosis of bipolar I or II disorder or alcohol dependence;
• acute or unstable systemic medical disorder;
• inability to comply with the requirements of informed consent or the study protocol;
• history of intolerance or allergy to study medications;
• Current pregnancy or breast feeding;
• Current regular use of statins, corticosteroids, or any other immunomodulatory agents; and
• Females on Contraception.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

El demerdash hospital

Cairo, Al Abbasia, +02, Egypt

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Rosuvastatin Calcium; Tablets; Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; 1-Naphthylamine; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds

Central Study Contacts

Silvana Nader

CONTACT

01226058776; Slvana_nader@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer

Model Details: \- Study Interventions The study is a 12-week, parallel group, randomised controlled trial (RCT) in participants with mild to moderate MDD. A baseline line assessment will be done by obtaining the socio-demographic data for the whole participants and The participants will be allocated into either groups First Group:Participants will receive Selective Serotonin Reutake Inhibitors (SSRI)(Sertraline). Second Group:Participants will receive Selective Serotonin Reutake Inhibitors (SSRI) (Sertraline) and rosuvastatin 10 mg/day. Assessments will be scheduled at baseline and weeks 4, 8, and 12. Randomisation and Blinding: Participants will be allocated into either 2 groups: control group (SSRI only) or interventional group (SSRI plus statins) randomly by giving them sealed envelopes containing code for control or interventional group Interventions: The participant will be randomly assigned to the interventional, or control group on a 1:1 basis.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: October 1, 2022
• Primary Completion: December 4, 2024
• Study Completion: December 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)