Testing Rosuvastatin for treating 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.

This study is testing if taking Rosuvastatin can help adults aged 20 to 45 with Major Depressive Disorder feel better over three months.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 145 (estimated)
• Ages: 20 Years to 45 Years
• Sex: All
• Sponsor: Ain Shams University (other)
• Locations: 1 site (Cairo, Al Abbasia)
• Trial ID: NCT06698666 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of Rosuvastatin 10 mg in treating adults with Major Depressive Disorder (MDD). Participants aged 20 to 45 will take the medication daily for three months while attending regular checkups at the Psychiatry Institute of Professor Ahmed Okasha. The study will assess changes in depression severity using the Montgomery Asberg Depression Rating Scale (MADRS) and monitor any side effects experienced by participants. The trial is designed as a randomized controlled trial to ensure robust results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 45 with a diagnosis of mild to moderate Major Depressive Disorder.

Not a fit: Patients with psychotic disorders, bipolar disorder, or those currently using statins may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Major Depressive Disorder.

How similar studies have performed: While the use of statins for depression is a novel approach, there have been limited studies exploring this connection, indicating potential for new insights.

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

Where this trial is running

Cairo, Al Abbasia

• El demerdash hospital — Cairo, Al Abbasia, Egypt (RECRUITING)

Study contacts

• Study coordinator: Silvana Nader

Conditions: Major Depressive Disorder, MDD, Rosuvastatin, Major depressive disorder, MADRS scale