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临床试验/DRKS00000403
DRKS00000403尚未招募4 期

Effect of intranasal oxytocin on social approach in patients with social phobia and healthy control - OXT_fMRT

Rheinisch-Westfälische Technische Hochschule Aachenvertretn durch das CTC-A derMedizinischen Fakultät der RWTH Aachen0 个研究点目标入组 96 人开始时间: 2010年5月10日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
96

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 45 Years(—)
性别
All

入选标准

  • inclusion criteria for control group:
  • Age between 18 and 45,
  • Full capacity to understand and execute instructions of the study,
  • signed form of consent.
  • inclusion criteria for patient group:
  • Age between 18 and 45,
  • diagnosis of social phobia (according to ICD-10),
  • The screening methods applied are the Social Phobia Inventory (SPIN, patient assessment) using a minimal score of 19 and the Liebowitz Anxiety Scale (LAS, assessment by interviewer, minimal score of 55 points),
  • Full capacity to understand and execute instructions of the study,
  • signed form of consent.

排除标准

  • Sinistrality
  • Neurological or Somatic illness affecting the cerebral function (e.g. Parkinsons Disease, Epilepsy, Multiple Sclerosis, Brain Tumor)
  • Psychiatric disorder according to ICD-10-WHO F0-F3, F8
  • Psychiatric disorder according to ICD-10-WHO F (applicable in patients only in untreated or if acute occurrence in the last six months)
  • Incorporated metal
  • Positive drug test and accordingly supposed or actual alcohol or drug abuse
  • Consumption of centrally acting substances (Except therapeutic in patients)
  • Persons committed governmental or legally to an institution
  • Any other medical condition or treatment that could interfere with the security, tolerance or efficacy in appraisal of the investigators
  • Participation in other or interfering clinical studies concurrently or in the last 90 days or 5 half-lives of the medical substance, respectively (whichever is longer), before screening
  • hormonal contraception
  • Individuals in dependence or working relationship with the sponsor or PI
  • Additionally in women: current of former pregnancy

研究者

发起方
Rheinisch-Westfälische Technische Hochschule Aachenvertretn durch das CTC-A derMedizinischen Fakultät der RWTH Aachen

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