CTRI/2018/06/014537招募中不适用
A prospective, observational study to assess the effects of SSRI and SNRI on cognitive function in patients of Major Depressive Disorders (MDD)
Department of Pharmacology IPGMER1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年3月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in cognitive function score
研究概览
简要总结
The primary purpose of the study is to study the effects of SSRI and SNRI on various domains of cognitive functions in patients with Major Depressive Illness. The secondary purpose of the study is to asses the nature of cognitive function changes due to use of drugs of interest.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (18 years to 50 years) of either gender attending psychiatry OPD at IOP, with a clinical diagnosis of Major Depressive Disorder as per ICD10 criteria. 2)Subjects of MDD must be in remission phase with a Hamilton Depressive Rating Score (HAM-D 17) of <7) at enrolment and taking any of the following SSRIs.
- •fluoxetine, sertraline, escitalopram and/or SNRI like mirtazapine for at least last 6 months. Patients who are additionally on cognitive behavioral therapy (CBT) as part of their treatment shall also be included. 3)Subjects should have at least 8 years of formal school education in order to undertake the cognitive function tests. 4)Subjects or their care givers should be willing to give written informed.
排除标准
- •History of post traumatic or Obsessive compulsive Disorder (OCD) 2)History of schizophrenia, psychosis or bipolar delusional disorder 3)History of intake of any drugs that are likely to have effect on cognition (anticonvulsants, sedative hypnotics, neuroleptics, opioids) 4)History of addictions- alcohol, substance abuse.
结局指标
主要结局
Changes in cognitive function score
时间窗: Attime points- 3, 6 and 9 months from the date of commencement of study.Both the absolute changes and percentage change from enrollment visit to 9 months visit shall be computed.
次要结局
- the nature of the changes in different domains of cognitive functions and to analyze whether there are any observable differences in the effects of the individual drugs on cognitive function.(At time points- 3, 6 and 9 months from the date of commencement of study.)
研究者
研究点 (1)
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