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临床试验/NCT00183729
NCT00183729已完成4 期

Memantine for Enhancement of Rehabilitation Efficacy and Prevention of Major Depressive Disorder in Older Adults

Eric Lenze1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Depressive Symptoms

研究概览

简要总结

This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or cardiopulmonary condition.

详细描述

Depression is a serious medical illness that is often difficult to diagnose and treat. It occurs in people of all ages, but is often overlooked in older adults. Depression frequently co-occurs with other serious illnesses, and may be mistaken by both patients and health care givers as a normal consequence of the illness. However, these misconceptions toward depression contribute to the underdiagnosis and undertreatment of depressive disorders in older people. In turn, depression may hinder a patient's recovery from an illness. This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or a cardiopulmonary condition.

This double-blind study will last for 12 months. Participants will be randomly assigned to receive either placebo or memantine, which is a drug that is often used to treat Alzheimer's disease. Both memantine and placebo will be administered to participants for 12 weeks. All participants will be followed for an additional 40 weeks. Outcome measurements will include participants' depressive symptoms, motivation, and learned helplessness. In addition, medication side effects, functional outcome, and incidence of major depressive disorder will be measured. All measurements will be taken at Week 12 and Month 12.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission to a skilled nursing facility for rehabilitation within 3 months of recent disabling medical event (e.g., hip fracture)
  • Medically stable (e.g., no active seizures, delirium, unstable pulse/blood pressure)

排除标准

  • Aphasia or cognitive impairments sufficiently severe to prevent valid assessment (e.g., a score of less than 22 on the Mini Mental State Examination)
  • Current major depressive episode
  • History of or current psychosis or mania
  • Current substance or alcohol abuse or dependence (within 3 months of study entry)
  • Current use of memantine
  • Sensitivity or contraindication to memantine
  • End-stage kidney, liver, heart, or lung disease
  • Recent hemorrhagic stroke
  • A FIM score of greater than 70 (on a 91 point scale)

研究组 & 干预措施

Memantine (1)

Experimental

Memantine for 12 weeks

干预措施: Memantine (Drug)

Placebo (2)

Placebo Comparator

Placebo for 12 weeks

干预措施: Placebo (Other)

结局指标

主要结局

Depressive Symptoms

时间窗: week 0, week 12

Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)

次要结局

  • Incidence of Major Depressive Disorder(week 12)
  • Functional Recovery(week 0, week 12)

研究者

发起方
Eric Lenze
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eric Lenze

Professor of Psychiatry

University of Pittsburgh

研究点 (1)

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