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

Phase 1

Active, not recruiting

• Conditions: Schizophrenia; MedDRA version: 21.1Level: LLTClassification code 10040707Term: Simple type schizophrenia, chronic stateSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2017-001357-14-DE
• Lead Sponsor: Klinikum der Universität München - AöR verteten durch den Vorstand des Bereiches Humanmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-27
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 60

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
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

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
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified