To study Memantine as an add-on drug to Escitalopram for Geriatric depression: A double-blind trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary outcome will be assessed on Hamilton Depression Rating Scale (HAM-D) and GDS-15.
研究概览
简要总结
Geriatric depression significantly decreases the quality of life and affects 10-15% of individuals. Co-morbid cognitive impairment in late-life depression is prevalent and disabling. Hence treatment strategies targeting depression and neurocognitive deficits in older adults are needed. This study aims to study the efficacy of administration of Memantine as an add on to Escitalopram compared with placebo and Escitalopram for improving mood and cognitive function in older function in older adults with Major depression and mild cognitive impairment. The study is a randomized double-blinded placebo-controlled trial, conducted on 60 patients with age more than 60 years diagnosed as Major depressive disorder, currently receiving Escitalopram 10-20 mg/day, presenting to Department of Psychiatry, DMC&H, Ludhiana. The patients will be randomly allocated into 2 groups of 30 each receiving either Memantine 10 mg or the placebo for 6 weeks. Evaluation will be done using Hamilton Depression Rating Scale (HAM-D), Geriatric Depression Scale (GDS) and neurocognitive tests. Patients will be assessed at 0,3 and 6 weeks, scores will be compared. The present study will draw attention to the fact that use of cognitive enhancers along with antidepressant therapy in older adults with major depression significantly improves mood and cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The patients with a diagnosis of Major depressive disorder according to DSM-5 criteria presenting to Department of Psychiatry,DMC&H, Ludhiana 2.Age group 60-99 years 3.Score of more than or equal to 16 on the 24-item Hamilton Rating Scale for Depression (HAM-D) 4.Score of more than 5 on Geriatric Depression Scale 5.Patients who have given consent for the study.
排除标准
- •1.History of any other major psychiatric disorder 2.Recent or current unstable medical or neurological disorder 3.Diagnosis of moderate/severe cognitive impairment and patients with dementia (Dementia screening by Clinical Dementia Rating Score of 0.5) 4.Known allergic reaction to Escitalopram or Memantine 5.Patients who have not given consent for the study.
结局指标
主要结局
Primary outcome will be assessed on Hamilton Depression Rating Scale (HAM-D) and GDS-15.
时间窗: Depressed mood and neurocognitive function will be judged in the beginning,3 weeks and at the end of the study and the scores will be compared.
次要结局
- Neurocognitive function assessment(Neurocognitive function will be judged in the beginning,3 weeks and at the end of the study)
研究者
Dr Navkiran S Mahajan
Dayanand Medical college and hospital