NCT06698666 Efficacy of Statins Among Major Depressive Disorder
| NCT ID | NCT06698666 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ain Shams University |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 145 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2024-12-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 145 participants in total. It began in 2022-10-01 with a primary completion date of 2024-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, corticosteroids, or any other immunomodulatory agents; and * Females on Contraception.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06698666 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 45 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06698666 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 145 participants.
Is NCT06698666 currently recruiting?
Yes, NCT06698666 is actively recruiting participants. Contact the research team at Slvana_nader@med.asu.edu.eg for enrollment information.
Where is the NCT06698666 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06698666 clinical trial?
NCT06698666 is sponsored by Ain Shams University. The trial plans to enroll 145 participants.