跳至主要内容
临床试验/DRKS00028001
DRKS00028001尚未招募2 期

europhysiological Correlates of Deep Pressure Stimulation in Adult Patients with ADHD Compared to Healthy Controls - EEG and PET-fMRI scan

niversität Leipzig Paul-Flechsig Institut für Hirnforschung0 个研究点目标入组 40 人开始时间: 2022年1月31日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40

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 60 Years(—)
性别
All

入选标准

  • Age of study participants = 18 years and < 60 years
  • - ADHD in adulthood according to DSM-V criteria
  • - Ability to understand study information and provide written informed consent
  • - Ability to follow study procedures and lie flat in PET-MRI scanner
  • - Written consent to study participation
  • - Consent in accordance with Section 7, Paragraph 2, No. 15 of the GCP Ordinance on the transfer of pseudonymised data as part of the documentation and notification obligations under Sections 12 and 13 of the GCP Ordinance.
  • - Drug-naive or if you have previously taken methylphenidate or atomoxetine with a 4-week washout period for the respective drug (methylphenidate or atomoxetine)

排除标准

  • - Age: < 18 years and = 60 years
  • - BMI < 19 or = 30 kg/m2
  • - Acute suicidality
  • - Addiction to illegal drugs in the last 6 months (DUDIT, Berman 2005)
  • - Dependence on alcohol in the last 6 months (AUDIT, Selin 2006)
  • - Psychotic symptoms
  • - Co-morbid organic mental disorder (ICD-10:F0) or schizophrenic disorder (ICD-10:F2) (SKID) (First, 1995)
  • - Presence of a major depressive episode or a manic episode
  • - Pregnancy
  • - Nursing mother
  • - Neurosurgical interventions in the past
  • - structural tissue lesions (e.g. cerebral infarction, head trauma, etc.)
  • - long-term use of psychotropics
  • - Taking prednisolone or methylprednisolone
  • - Simultaneous participation in an interventional clinical trial according to AMG (drug testing)

研究者

发起方
niversität Leipzig Paul-Flechsig Institut für Hirnforschung

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