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临床试验/NCT00591825
NCT00591825已完成2 期

An fMRI Study Investigating the Effects of Acute D-cycloserine Administration on Brain Activations and Cognitive Functioning in Spider Phobia.

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
54
试验地点
1
主要终点
fMRI Brain Activations During Symptom Provocation

研究概览

简要总结

The research team hopes to use brain imaging and mental testing to learn more about specific phobias and the treatment of phobia. When given directly prior to therapy sessions, D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify reasons why D-cycloserine has this effect by measuring brain activity.

详细描述

Exposure and Response Prevention (ERP) therapy has become the treatment of choice for specific phobias. ERP involves systematic and repeated exposure to a feared or anxiety-provoking stimulus, leading to habituation and extinction of the fear response. Animal models of fear extinction have shown that acute administration of D-cycloserine (DCS) prior to exposure to a feared stimulus enhances extinction of that fear. A recent study in human subjects with height phobia (a specific phobia) has also demonstrated that DCS facilitates the effects of ERP therapy. Current theories postulate that DCS facilitates fear extinction by enhancing the learning process and increasing consolidation of memories, but the neural mechanisms underlying this process are not understood. The proposed research aims to elucidate these mechanisms by using fMRI to measure brain activation during 1) symptom provocation and verbal learning two hours post-medication, and 2)repeated symptom provocation and verbal recognition one week post-medication. This research will also examine the effects of DCS on cognitive functioning using neuropsychological testing both two house and one week post-medication.

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, Care Provider, Investigator)

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

  • Right-handed
  • Adults between 18 and 55 years of age
  • Subjects in the phobic group will additionally meet diagnostic (DSM-IV) criteria for spider phobia.
  • Individuals of both genders and all races will be included

排除标准

  • Women who are breastfeeding or pregnant
  • Individuals with medical conditions unsuitable for MR scanning
  • Individuals reporting a history of epilepsy or seizures
  • Individuals reporting an allergy to cycloserine
  • Individuals diagnosed with asthma or who report previous anaphylactic reaction to insect stings/bites, medication, food, or other material and/or event
  • Individuals reporting present or past diagnosis of a developmental disorder, neurological disorder, or head injury *Individuals found to have Axis I psychopathology as defined by the DSM-IV (other than spider phobia)
  • Individuals currently taking any psychotropic medication

研究组 & 干预措施

Non-Phobic Control - Placebo

Placebo Comparator

Participants without phobia will be given one placebo administration.

干预措施: Placebo (Drug)

Non-Phobic Control - DCS

Active Comparator

Participants without phobia will be given one D-cycloserine (DCS) administration of 100mg.

干预措施: D-cycloserine (Drug)

Spider-phobic Placebo

Placebo Comparator

Participants with phobia will be given one placebo administration.

干预措施: Placebo (Drug)

Spider-phobic DCS

Experimental

Participants with phobia will be given one D-cycloserine (DCS) administration of 100mg.

干预措施: D-cycloserine (Drug)

结局指标

主要结局

fMRI Brain Activations During Symptom Provocation

时间窗: 2 Weeks

Regions of interest (ROIs) were specified based on previous research and included amygdala, insula, dorsal anterior cingulate cortex (ACC), dorsolateral PFC (dlPFC), and hippocampus. Multiple regression analyses were used to examine differences in response between experimental conditions (spider versus butterfly images). For significant clusters of activation within ROIs, the average max percent signal change is reported. For other regions, the average max percent signal change is reported within a sphere centered at coordinates identified via previous research.

次要结局

  • Cognitive Functioning Measured Using the Iowa Gambling Test(2 weeks)
  • Cognitive Functioning Measured Using the Wisconsin Card Sorting Task(2 weeks)
  • Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests)(2 Weeks)
  • Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT)(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cary Savage, Ph.D.

Director, CHBN and John H. Wineinger Professor of Psychiatry and Behavioral Sciences

University of Kansas

研究点 (1)

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