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临床试验/DRKS00013260
DRKS00013260已完成2 期

Enhancing the efficacy of tDCS by nicotinergic stimulation in schizophrenia - NicStim

Klinikum der Universität München, Campus Großhadern0 个研究点目标入组 34 人开始时间: 2017年12月29日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
34

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 65 Years(—)
性别
All

入选标准

  • competent male and female participants between 18 and 65 years old who meet the diagnostic criterias for an schizophrenia diagnosis Statistical Classification of Diseases and Related Health Problems (ICD-10)
  • - stable antipsychotic treatment with one antipsychotic drug. Conformity with treatment guidelines must be given. If required a combination of two antipsychotic drugs is possible as long as total dosis is under 1000mg CPZ
  • - Severity of psychopathology is measured with PANSS und must be under a total of 75 points
  • - no severe depressive symptoms CDSS<8
  • - negative pregnancy test for women
  • - usage of contraceptive methods (CTFG 2014)

排除标准

  • - positive pregnancy test for women
  • - acute suizidal tendencies or danger of harming others
  • - severe neuronal or internistic injuries/disease
  • - schizophrenia which is resistant to Treatment and Treatment with clozapin
  • - known non-compliance regarding intake of medication
  • - beginning of treatment with antidepressiva, benzodiazepine or mood stabilisers during intervention. Stable medication with the mentioned medication can maintain unchanged.
  • - addiction to alcohol or substances 6 months prior to intervention (not including coffein). During the Intervention the intake of addictive substances is not allowed (not including coffein)
  • - epileptic attacks in the past
  • - characteristical potentials of epilepsy in the EEG
  • - positive drug Screening measured with laboratory urine and cdt test
  • - creatinine outside of normal range
  • - intolerance to study medication or tDCS stimulation
  • - Patient can not give consent or is under medical treatment against his/her will
  • - no sufficient knowledge of german language
  • - state of health which is resistent to Treatment or was never treated before

研究者

发起方
Klinikum der Universität München, Campus Großhadern

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