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RecruitingPhase 3NCT06698666

Efficacy of Statins Among Major Depressive Disorder

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Plain-language summary for patients

Trial Parameters

ConditionMajor Depressive Disorder
SponsorAin Shams University
Study TypeINTERVENTIONAL
PhasePhase 3
Enrollment145
SexALL
Min Age20 Years
Max Age45 Years
Start Date2022-10-01
Completion2024-12-04
Interventions
Rosuvastatin 10 mg tablet.Sertraline Pill

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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)

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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,

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