The Efficacy of Statins in Management of Major Depression Disorder (MDD) Among Adult Patients Attending the Outpatient Clinics of El Demerdash Hospital.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Severity of depression among Participants with MDD as Assessed by MADRS scale
研究概览
简要总结
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)
详细描述
- Type of Study: Randomised Controlled Trial (RCT)
- Study Setting: Psychiatry institute of Professor Ahmed Okasha, El- Demerdash hospitals.
- Study Period: starting from September 2022 till completion of sample size
- Study Population
Any adult patient aged 20 -45 years old attending the psychiatric clinic at the Psychiatry institute of Professor Ahmed Okasha, El- Demerdash hospitals with mild or moderate depression.
Diagnostic criteria for minor depression according to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
We diagnose minor depressive episodes according to all of the following criteria (A through F).
A. Two to four of the following symptoms have been present during the same two-week period:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
The Control Group
The Control Group will receive the standard treatment of depression including SSRI (Sertraline) only
The Interventional group
the interventional group will receive the standard treatment of depression including SSRI (Sertraline) in addition to the10 mg/day rosuvastatin
结局指标
主要结局
Severity of depression among Participants with MDD as Assessed by MADRS scale
时间窗: 3 months (12 weeks)
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.
次要结局
未报告次要终点
研究者
Silvana Nader
Assisstant lecturer
Ain Shams University