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Clinical Trials/EUCTR2017-001357-14-DE
EUCTR2017-001357-14-DE
Active, not recruiting
Phase 1

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 sites60 target enrollmentJuly 27, 2017
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Klinikum der Universität München - AöR verteten durch den Vorstand des Bereiches Humanmedizin
Enrollment
60
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 27, 2017
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • •\- 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

Exclusion Criteria

  • •\- 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

Outcomes

Primary Outcomes

Not specified

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