Enhancing the efficacy of tDCS by nicotinergic stimulation in schizophrenia
- Conditions
- F20Schizophrenia
- Registration Number
- DRKS00013260
- Lead Sponsor
- Klinikum der Universität München, Campus Großhadern
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 34
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)
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of working memory performance measured with the n-back task. Points of measurement follow the intervention as well as four and eight weeks after the beginning of the treatment.
- Secondary Outcome Measures
Name Time Method Improvement of neurocognitive functions one, four and eight weeks after the treatment. <br>Changes in psychiatric symptoms measured with PANSS, CDSS.<br>Changes in CGI and GAF,<br>appearence of adverse Events, changes in cortical excitability.