Randomized, doubleblind, 4-arms, monocentric, interventinal Study for enhancing the efficacy of tDCS across from single intervention or Placebo by nicotinergic stimulation in schizophrenia.

Klinikum der Universität München - AöR verteten durch den Vorstand des Bereiches Humanmedizin0 个研究点目标入组 60 人开始时间: 2017年7月27日最近更新: 2021年12月13日

适应症

试验速览

暂无简介。

•- Male and female (with contraception) patients with schizophrenia (ICD-10 Criteria), age 18 to 65 being diagnosed according to the Statistical
•Classification of Diseases and Related Health Problems (ICD-10). Diagnosis will be confirmed via the MINI interview.
•- Antipsychotic monotherapy or a maximum combination of two antipsychotics with a maximum dosage of 1000 mg CPZ equivalents (using the
•minimum effective dose method)
•- Being no longer in the acute phase of illness defined as (PANSS Total = 75, CGI = 4). No relevant depressive symptoms (CDSS < 8)
•- Female patients of childbearing potential: use of a proper method of contraception (according to the CTFG guideline) and negative pregnancy test
•before study inclusion
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Lacking capacity to give informed consent or involuntary treatment
•- Pregnancy or lactation
•- Current suicidality as well as the risk to injure others
•- Treatment resistance or Treatment with Clozapin
•- Never treated schizophrenia or documented non-compliance
•- Lacking german language skills
•- Start of antidepressants or mood stabilizers during the 1-week intervention phase. Previous treatment can be continued in unaltered dosages.
•- Alcohol- or substance abuse during the last 6 months before inclusion into study except for Coffein and Nicotin (smoker), no narcotic drugs may be taken during the 1-week intervention phase
•- Detection of active substance abuse by positive D-Urin or CDT test before start of the intervention
•- Epileptic seizures in the anamnesis
•- Epileptic potentials in EEG
•- Proof of active substances by positve results in D-urine or CDT.
•- Moderate kidney insufficiency (creatinine-clearance: 30–50 ml/min) or severe kidney insufficiency (< 30 ml/min)
•- Known intolerance to the study medication (Vareniclin) or to tDCS
•- Clinically relevant interaction between clinically necessary per-medication and investigational medicinal product (to be tested by medic software
•- Known intolerance to the study medications or to tDCS

发起方

Klinikum der Universität München - AöR verteten durch den Vorstand des Bereiches Humanmedizin