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临床试验/NCT00178035
NCT00178035已完成4 期

Geriatric Depression: Neurobiology of Treatment

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 1999年12月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
158
试验地点
2
主要终点
Combined treatment of total sleep deprivation(TSD)for one night + paroxetine will be superior to the combination of placebo + TSD and to paroxetine alone (without TSD)in bringing about rapid resolution of depressive symptoms.

研究概览

简要总结

This study will determine the effectiveness of total sleep deprivation (TSD) for one night plus paroxetine versus either TSD plus placebo or paroxetine alone in inducing rapid symptom resolution of major depression in the elderly.

详细描述

The clinical response to antidepressant treatment in the elderly is variable and often slow, and difficult to predict reliably before 4-5 weeks of treatment. The delayed onset of antidepressant activity is particularly problematic in the elderly, prolonging the duration of suffering and disability, reducing compliance, and increasing the risk for attempted and completed suicide.

This study seeks to develop a method for effective rapid treatment of major depressive episodes in the elderly and to improve early identification of treatment non-responders, by combining sleep deprivation (for one night) and paroxetine as probes of treatment response and treatment resistance.

This is an experimental study that is randomized, double-blind, and placebo-controlled. We will recruit 158 elderly depressed patients with current major depressive episodes and randomly assign 36 patients to each of three interventions: 1)TSD + paroxetine; 2)TSD + placebo; and 3)paroxetine alone without TSD). The duration of the experimental phase of the study is 17 days: 3 days for pre-treatment sleep studies and 14 days for initial paroxetine or placebo treatment under double-blind conditions.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00177294

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double

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

  • Age 60 and older
  • Current episode of unipolar, major depression
  • HRSD (17 item)score of 15 or higher
  • Folstein Mini-Mental Status exam score of 17 or higher

排除标准

  • Lifetime diagnosis of any psychotic disorder
  • Lifetime diagnosis of bipolar disorder
  • _Alcohol or drug abuse within the past 6 months
  • Contraindication to treatment with SSRI therapy
  • History of seizure disorder
  • Baseline apnea/hypopnea index of 20 or higher
  • Hyponatremia

结局指标

主要结局

Combined treatment of total sleep deprivation(TSD)for one night + paroxetine will be superior to the combination of placebo + TSD and to paroxetine alone (without TSD)in bringing about rapid resolution of depressive symptoms.

次要结局

  • EEG Sleep measures
  • MRI
  • Cognitive status: Folstein Mini-Mental Status Exam, and CDR
  • Quality of Life measures: Quality of Wellbeing Scale, CIDI Health Services Utilization, OARS, GAF, PSQI, SF-36, UKU, and CIRS-G
  • Social Support: Interpersonal Support Evaluation List, Luben Social Network Scale
  • Psychiatric status: SCID, Hamilton Depression Rating Scale, Suicidal History Questionnaire, Antidepressant Treatment History Form, Brief Psychiatric Rating Scale, and anxiety subscale of Brief Symptom Inventory

研究者

申办方类型
Other

研究点 (2)

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