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临床试验/NCT02616549
NCT02616549已完成2 期

A Randomized Study of a Comprehensive Yoga Intervention for Patients With Major Depressive Disorder With Incomplete Response to Antidepressants

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
25
试验地点
1
主要终点
17-item Hamilton Depression Rating Scale

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of a multi-component yoga intervention featuring Sudarshan Kriya Yoga (SKY) as an adjunctive treatment for patients with Major Depressive Disorders with incomplete response to antidepressants.

详细描述

According to the World Health Organization, compared to two hundred health conditions, depression is ranked as the second leading cause of disability worldwide. The annual prevalence of Major Depressive Disorder (MDD) in the United States is estimated at 7% and the lifetime risk approximately 17%. Depression is associated with approximately 75% of all deaths by suicide, resulting in immense suffering for families and society at large. 83 billion dollars are spent per year on treatment and lost productivity related to the disorder. Current treatments for MDD have remission rates between 35-50%. Patients who respond to treatment, but do not experience clinical remission are at markedly increased risk for relapse. Approximately 50% of patients treated with two trials of antidepressant interventions do not achieve clinical remission. Consequently, novel evidence-based treatment modalities that can further treat this devastating disorder are needed. Mind-body interventions constitute a large and diverse group of practices that reduce both stress and inflammation and are increasingly being evaluated in the treatment of MDD The 2007 NHIS concluded that 16.6% of U.S. adults, representing 34.1 million Americans, used at least one mind-body intervention in the past year. Initial studies with different mind-body interventions have been shown to improve outcomes in MDD. A recent meta-analysis gave a Grade B for current evidence for the use of yoga as an intervention for MDD. Sudarshan Kriya Yoga (SKY) is a advanced yogic breathing intervention that has been reported to relieve symptoms of major depressive disorder and generalized anxiety disorder. In MDD, SKY can correct the P300 amplitude, decrease plasma cortisol levels and increase plasma prolactin levels. In a small-scale randomized controlled trial, 45 consenting inpatients meeting criteria for DSM-IV severe, melancholic depression were randomized to receive SKY, electroconvulsive therapy (ECT) or imipramine treatment for four weeks (Janakiramaiah et al. 2000). Consequently, the rigorous evaluation of a multicomponent yogic intervention featuring SKY as an adjunctive treatment for adults with MDD warrants further study.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-IV Major Depressive Disorder
  • Able to give informed consent
  • Aged 18-67
  • Currently in outpatient care for MDD
  • On a stable antidepressant regimen for at least 2 months
  • 17-item Hamilton Depression Score >14 at screening & baseline visit

排除标准

  • Currently in crisis requiring inpatient treatment
  • Bipolar Disorder, Psychotic Disorder, ADHD, Substance Use Disorder
  • Pregnancy, Epilepsy
  • Initiating psychotherapy or other yoga/meditation program

研究组 & 干预措施

Sudarshan Kriya Yoga

Experimental

干预措施: Sudarshan Kriya Yoga (Behavioral)

Waitlist Control

No Intervention

结局指标

主要结局

17-item Hamilton Depression Rating Scale

时间窗: Baseline to 2 month

次要结局

  • Beck Anxiety Inventory(Baseline to 2 month)
  • Beck Depression Inventory(Baseline to 2 month)
  • Columbia Suicide Severity Rating Scale(Baseline, 1 month, 2 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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