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

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether statin medications (drugs commonly used to lower cholesterol) can also reduce depression symptoms in adults with major depressive disorder (MDD) who are already on standard antidepressant treatment. **You may be eligible if...** - You are between 20 and 45 years old - You have been diagnosed with major depressive disorder with mild to moderate current symptoms - You have been on a stable antidepressant medication for at least 2 weeks - You are male or female and can give informed consent **You may NOT be eligible if...** - You have a history of bipolar disorder, psychosis, or other serious psychiatric conditions - You have liver problems or other conditions that make statin use unsafe - You have had recent suicidal behavior - You are currently pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

El demerdash hospital

Cairo, Al Abbasia, Egypt

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NCT06698666


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