RecruitingPhase 3NCT06698666

Efficacy of Statins Among Major Depressive Disorder

The Efficacy of Statins in Management of Major Depression Disorder (MDD) Among Adult Patients Attending the Outpatient Clinics of El Demerdash Hospital.

Sponsor

Ain Shams University

Enrollment

145 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder MDD

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)

Eligibility

Min Age: 20 YearsMax Age: 45 Years

Inclusion Criteria6

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.

Exclusion Criteria8

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.

Interventions

DRUGRosuvastatin 10 mg tablet.

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.

DRUGSertraline Pill

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