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

Plain English Summary

Efficacy of Statins Among Major Depressive Disorder is a Phase 3 clinical trial sponsored by Ain Shams University studying Major Depressive Disorder, MDD. Tests if statins can help treat depression in adults. For adults with mild to moderate depression, aged 20-45. Participation involves taking Rosuvastatin 10 mg daily and clinic visits every 4 weeks. Alternatives include other antidepressants like Sertraline. The trial aims to enroll 145 participants.

Official 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)

Who Can Participate

Here is what you need to know about eligibility for this trial. Ages 20-45, diagnosed with depression, can speak English, no serious health issues, not pregnant, not taking statins or similar medications. Cannot have a psychotic disorder, bipolar disorder, or alcohol dependence, and must be stable on current medication for at least 2 weeks. This trial is studying Major Depressive Disorder, MDD, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the reduction in depression severity using the MADRS scale, helping patients track their improvement. The specific primary outcome measures are: Severity of depression among Participants with MDD as Assessed by MADRS scale (3 months (12 weeks)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill the gap in understanding how statins can help treat depression, offering a new potential treatment option. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Major Depressive Disorder, MDD, where improved treatment options are needed.

Investor Insight

Market size is significant, with a growing need for effective depression treatments, and a competitive landscape with limited alternatives. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor about your current health status and if you meet the age criteria. Expect to take Rosuvastatin 10 mg daily and attend clinic visits every 4 weeks. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 145 participants

Interventions

• 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 ass
• DRUG: Sertraline Pill — Both control and intervention group will receive the sertraline as a standard therapy

Primary Outcomes

• Severity of depression among Participants with MDD as Assessed by MADRS scale (3 months (12 weeks))

Full 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.

Trial Locations

• El demerdash hospital, Cairo, Al Abbasia, Egypt

Frequently Asked Questions

Related Conditions

• Depression, anxiety, bipolar disorder, schizophrenia, and mood disorders.
• Therapeutic areas include mental health and neurology.

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