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Cortical GABA Concentrations in Insomnia

2013年1月18日 更新者:Gerard Sanacora、Yale University

The Association of Cortical GABA Concentrations in Subjects With Primary Insomnia and Depression in Partial Remission With Residual Insomnia

Disturbances in the amino acid neurotransmitter (AANt), gamma-amino butyric acid (GABA) function are hypothesized to contribute to the neurobiology of Major Depressive Disorder (MDD) and insomnia. The principal objective of this project is to use magnetic resonance spectroscopy (MRS) to provide the first in vivo characterization of cortical GABA levels in individuals with primary insomnia, and to determine whether subjects with MDD, achieving a partial response with selective serotonin reuptake inhibitor treatment but still experiencing significant residual symptoms including insomnia, have altered levels of this neurotransmitter. The investigators are also exploring the correlation between cortical AANt levels and abnormalities in sleep parameters in primary insomnia and as a residual symptom of major depression.

研究概览

地位

完全的

详细说明

Three groups of subjects (MDD with partial remission and residual insomnia, primary insomnia, and healthy) will participate in the study. All subjects will complete a telephone screening, and if appropriate a complete face-to-face evaluation, to determine their eligibility for the study. All subjects meeting eligibility criteria for the study will complete a baseline MRS session to evaluate differences in GABA concentrations between the three groups.

研究类型

观察性的

注册 (实际的)

23

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Connecticut
      • New Haven、Connecticut、美国、06519
        • Yale Depression Research Program

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 55年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Community sample

描述

Patient Sample.

  • Healthy subjects without insomnia (Group A) (n=10)
  • Subjects with primary insomnia (Group B) (n=20)
  • Subjects with a history of major depressive disorder and currently in partial remission but with residual insomnia (Group C) (n=20)

Inclusion Criteria for Primary Insomnia Subjects:

  • Males or females between the ages of 25 and 55 years
  • Clinical diagnosis of primary insomnia meeting DSM-IV criteria.
  • Current insomnia ratings (current Sleep Onset Latency SOL > 30 minutes, Insomnia Severity Index (ISI) > 14, total sleep time (TST) < 6.5 hrs/night).
  • No lifetime history of psychopathology other than primary insomnia.
  • No sleep disorders previously identified as related to other conditions including sleep disordered breathing, restless leg syndrome, periodic limb movement disorder, chronic pain, gastro-esophageal reflux disease, sleep paralysis, nocturnal seizures, nocturia, enuresis; also narcolepsy and REM behavior disorders (assessed by clinical interview and Harvard Center and Cognition Habitual Sleep Survey).

Inclusion Criteria for Depressed Subjects:

  • Males or females between the ages of 25 and 55 years
  • Clinical diagnosis of major depression meeting DSM-IV criteria in partial remission (HDRS-8-17), confirmed after semi-structured interview with the SCID and HDRS.
  • On monotherapy with a single SSRI medication for a period of at least 6-weeks.
  • Remaining symptoms of insomnia (current Sleep Onset Latency (SOL) > 30 minutes, Insomnia Severity Index (ISI) > 14, TST < 6.5 hrs/night).
  • Participation is judged clinically appropriate by treatment team.
  • No sleep disorders previously identified as related to other conditions including sleep disordered breathing, restless leg syndrome, periodic limb movement disorder, chronic pain, gastro-esophageal reflux disease, sleep paralysis, nocturnal seizures, nocturia, enuresis; also narcolepsy and REM behavior disorders.

Inclusion Criteria for Healthy Control Subjects:

  • Males or females between the ages of 25 and 55 years
  • No lifetime history of psychopathology or insomnia (current SOL < 30mins, ISI < 4, TST > 6.5 hrs)
  • At low risk for depression (e.g., no first degree relative with child onset, recurrent, psychotic or bipolar depression)

Exclusion Criteria for all Subjects:

  • History of serious medical or neurological illness
  • Signs of major medical or neurological illness on examination or as a result of laboratory studies
  • History of psychoactive substance and/or alcohol dependence or abuse in past 6-months.
  • Current use of any psychoactive medication or substance (with the exception of caffeine, as noted below, and the use of an SSRI in the depressed group), during the two weeks prior to the initial scan.
  • More than the caffeine-equivalent of 3 cups of coffee per day, or any regular (i.e., more than 1x/2 weeks) use of caffeine after 7pm.
  • Use of benzodiazepines or olanzapine in past 3-months.
  • Pregnant or nursing
  • Any implanted metal devise or metal fragments

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:横截面

队列和干预

团体/队列
1 Primary Insomnia
Individuals with insomnia not related to another identified cause.
3 Healthy comparison subjects
Healthy subjects with no history of insomnia

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Cortical GABA levels as measured by proton MRS
大体时间:baseline
baseline

次要结果测量

结果测量
大体时间
Ambulatory polysomnography
大体时间:baseline
baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Gerard Sanacora, M.D.,Ph.D.、Yale University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年11月1日

初级完成 (实际的)

2011年6月1日

研究完成 (实际的)

2011年6月1日

研究注册日期

首次提交

2008年10月1日

首先提交符合 QC 标准的

2008年10月2日

首次发布 (估计)

2008年10月3日

研究记录更新

最后更新发布 (估计)

2013年1月21日

上次提交的符合 QC 标准的更新

2013年1月18日

最后验证

2013年1月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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