RECRUITINGPhase 3INTERVENTIONAL

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.

About This Trial

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)

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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, corticosteroids, or any other immunomodulatory agents; and * Females on Contraception.

Treatments Being Tested

DRUG

Rosuvastatin 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.

DRUG

Sertraline Pill

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

Locations (1)

El demerdash hospital

Cairo, Al Abbasia, Egypt