Actively Recruiting
The Efficacy of Statins in Management of Major Depression Disorder (MDD) Among Adult Patients Attending the Outpatient Clinics of El Demerdash Hospital
Led by Ain Shams University · Updated on 2025-08-17
145
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Rosuvastatin 10 mg to treat Major Depressive Disorder (MDD) in adults aged 20 to 45 years with mild to moderate depression. This randomized controlled trial aims to determine if Rosuvastatin lowers depression severity, measured by the Montgomery Asberg Depression Rating Scale (MADRS), and to assess its safety. Participants must have a confirmed diagnosis of MDD and a MADRS score between 7 and 34. Participants will be assigned to one of two groups: a control group receiving the standard depression treatment with Sertraline, and an interventional group receiving Sertraline plus Rosuvastatin 10 mg daily for 3 months. Serum cholesterol levels will be measured at the start and after 12 weeks. Medication adherence is monitored by pill counts during clinic visits every 4 weeks. During the study, participants will visit the clinic once every 4 weeks for assessments including depression severity using MADRS, side effect monitoring, and blood tests for cholesterol levels. The primary outcome is the change in depression severity after 12 weeks. The total participation duration is approximately 3 months, with data kept confidential and ethical oversight provided by the Ain Shams University research committee.
CONDITIONS
Brief Title
Efficacy of Statins Among Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 45 years
- Diagnosis of current Major Depressive Disorder confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I/P)
- Montgomery Asberg Depression Rating Scale (MADRS) score between 7 and 34 indicating mild to moderate depression
- Ability to give informed consent and comply with study procedures
- Both males and females
- Stable pharmacological treatment for at least 2 weeks prior to enrollment if currently treated, except changes in dose or frequency
You will not qualify if you...
- Lifetime or current diagnosis of a psychotic disorder
- Lifetime diagnosis of bipolar I or II disorder or alcohol dependence
- Acute or unstable systemic medical disorder
- Inability to comply with informed consent or study protocol
- History of intolerance or allergy to study medications
- Current pregnancy or breastfeeding
- Current regular use of statins, corticosteroids, or other immunomodulatory agents
- Females using contraception
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive standard treatment for depression with sertraline; the interventional group also receives 10 mg/day rosuvastatin. Medication adherence is monitored at each visit.
Regular visits for medication adherence and assessments including serum cholesterol measurement at baseline and week 12
Trial Site Locations
Total: 1 location
1
El demerdash hospital
Cairo, Al Abbasia, Egypt, +02
Actively Recruiting
Research Team
S
Silvana Nader
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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