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临床试验/NCT01936506
NCT01936506已完成1 期

Cognitive Training for Depression

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
21
试验地点
1
主要终点
change in Hamilton Depression Rating Scale (Ham-D)

研究概览

简要总结

This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.

详细描述

There is an urgent public health need to develop more effective and well tolerated treatments for patients with major depressive disorder (MDD); cognitive training interventions aiming to modify cognitive and affective processing abnormalities underlying MDD represent a promising new strategy. This research project translates a well established cognitive bias in major depressive disorder (MDD), working memory bias, into a novel intervention target. In a double-blind, randomized, controlled study, MDD participants undergo 4 weeks of cognitive training sessions, with two sessions per week.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Primary, current Axis I diagnosis of Major Depressive Disorder according to DSM-IV criteria and Ham-D-17 score between 16-27
  • Age 18-55
  • Able to give informed consent

排除标准

  • A history of drug or alcohol abuse or dependence (DSM-IV criteria) within 6 months
  • Visual impairment that would affect the ability to observe the computerized presentation of faces.
  • Motor impairment that would affect the ability to provide a response by quickly pressing a button.
  • Lifetime history of Bipolar spectrum disorders or schizophrenia spectrum disorders.
  • Primary, current Axis I diagnosis other than Major Depressive Disorder
  • Primary, current Axis II personality disorder.
  • Currently attending a cognitive-behavioral psychotherapy regimen
  • Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
  • Pregnancy in women.
  • Subjects must exhibit no or only moderate alcohol use. Subjects with current excessive use of alcohol (> 8 ounces/day for men and > 6 ounces/day for women) are ineligible for participation, as such drug use could confound the results.

结局指标

主要结局

change in Hamilton Depression Rating Scale (Ham-D)

时间窗: baseline and week 4

Change in depression symptom severity at week 4 compared as to baseline

次要结局

  • change in Self-referential Information Processing Task(baseline and week 4)
  • change in Working Memory(baseline and week 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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