Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Reduction in the Beck Depression Inventory-II Score
研究概览
简要总结
Among the major depressive disorder (MDD) patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for MDD. Controls do not take any medicine.
详细描述
The research is a prospective, 2-month, double-blind study of parallel groups of patients with MDD with or without ketoprofen administration in addition to sertralin.
- Patients: A total of 140 patients with MDD (78 male and 62 female; aged 18-65 years) participated in the study. Two samples were obtained at the beginning and 2 months after treatment from 34 patients that were followed up for two months after treatment. The samples were collected from "The Psychiatry Unit" at Al-Hakeem General Hospital in Najaf Governorate-Iraq from November 2016 to August 2017. Patient samples were also obtained from a private psychiatric clinic that was run by an assistant professor in psychiatric medicine. The patients were diagnosed by psychiatrists in accordance with a semi-structured psychiatric interview schedule for MDD diagnosis based on the 10th revision of the International Statistical Classification of Diseases and Related Health Problems. The full medical histories of the patients were evaluated such that any existing systemic disease that may affect the parameters to be diagnosed, particularly diabetes, liver disease, and renal disease, were excluded. Patients with histories of these diseases were excluded from the study. Serum C-reactive protein (CRP) was negative in all of the samples (CRP<6 mg/L). This test was conducted to exclude the presence of any overt infection or inflammation that may elevate acute-phase-reactant proteins, especially CRP. The protocol was approved by the IRB of the University of Kufa. The patients or their close first-degree relatives provided informed consent in accordance with the procedures outlined by the current IRB.
Among the patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for MDD. 2. Controls: As part of the control group, 40 apparently healthy subjects (22 males and 18 females) were selected. Their sex and age were matched with those of the patients. These subjects were apparently free from psychiatric and somatic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients were diagnosed by psychiatrists in accordance ICD10 as having major depressive disorder.
- •The patients had no existing systemic disease that may affect the parameters to be diagnosed.
- •Patients with negative serum C-reactive protein (CRP<6 mg/L).
排除标准
- •Patients with any systemic disease particularly diabetes, liver disease, and renal disease
- •Patients with positive CRP
- •Patients who taking any other drugs
研究组 & 干预措施
Sertralin & Ketoprofen in MDD
To compare the median of Beck Depression Inventory-II (BDI-II) score of MDD patients after treatment with sertralin (50mg) daily+placebo and after treatment with combination of (sertralin & ketoprofen) for two months.
干预措施: Combined Sertraline & Ketoprofen (Combination Product)
Sertralin & Ketoprofen in MDD
To compare the median of Beck Depression Inventory-II (BDI-II) score of MDD patients after treatment with sertralin (50mg) daily+placebo and after treatment with combination of (sertralin & ketoprofen) for two months.
干预措施: Interleukins in MDD after treatment (Other)
Interleukins in MDD after treatment
Some Interleukines level were estimated before and after treatment with sertralin 50 mg in combination with either placebo or ketoprofen 100mg daily.
干预措施: Combined Sertraline & Ketoprofen (Combination Product)
Interleukins in MDD after treatment
Some Interleukines level were estimated before and after treatment with sertralin 50 mg in combination with either placebo or ketoprofen 100mg daily.
干预措施: Interleukins in MDD after treatment (Other)
结局指标
主要结局
Reduction in the Beck Depression Inventory-II Score
时间窗: 12 months
BDI-II is a 21-item self-report scale measuring current depressive symptoms. The standardized cutoffs used differ from the original: * 0-13: minimal depression * 14-19: mild depression * 20-28: moderate depression * 29-63: severe depression. Reduction in the Beck Depression Inventory-II Score by Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
次要结局
- Decrease in Serum of IL-1β, IL-6, and IL-18 Levels(12 months)
- Body mass index (BMI)(2 months)
研究者
Hussein Kadhem Al-Hakeim
Professor
Kufa University
