Efficacy of Statins Among Major Depressive Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-45
SponsorAin Shams University
About this trial
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
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Rosuvastatin 10 mg tablet.
DrugThe 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 assessed by a pill count.
Sertraline Pill
DrugBoth control and intervention group will receive the sertraline as a standard therapy
Treatment groups
145 Participants
are divided into 2 treatment groupsGroup A: The Control GroupOther 0 interventions
Group B: The Interventional groupExperimental treatment 0 interventions
Trial outcomes
Primary outcomes
1
Severity of depression among Participants with MDD as Assessed by MADRS scale
Severity of depression will be determined using the Montgomery Asberg Depression Rating Scale (MADRS) including those who are between 7 and 34. * The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy. * Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. * The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts * Time: Interviews take 20 to 60 minutes to complete.
Time frame
3 months (12 weeks)Sponsors and contacts
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Source ClinicalTrials.gov