Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 20 to 45

Testing Rosuvastatin for treating Major Depressive Disorder

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

Run by Ain Shams University · NCT06698666 · Data updated 2026-11-12

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

PhasePhase 3
Study typeInterventional
Ages20 Years to 45 Years
SexAll
Enrollment145 (estimated)
SponsorAin Shams University
Academic / other
Locations1 site (Cairo, Al Abbasia)
StatusRecruiting
StartedOctober 1, 2022
Main results expectedDecember 4, 2024
Study endsDecember 31, 2026
Registry record updatedNovember 4, 2026
Trial IDNCT06698666 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • El demerdash hospital
    Cairo, Al Abbasia, Egypt
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.