Effects of nicotinergic receptor stimulation with vareniclin on focal and non-focal plasticity in schizophrenia patients

Not Applicable

• Conditions: F20; Schizophrenia

• Registration Number: DRKS00013735
• Lead Sponsor: Klinik für Psychiatrie und Psychotherapie- Klinikum der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-10
• Study Completion: 2021-10-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

ensured schizophrenia diagnosis (ICD-10)
- Age 18-65 years
- stable antipsychotic treatment with one or two (maximum) antipsychotic drugs
- Severity of the psychopathology is measured with PANSS and CGI. The PANSS Rating must be under a total of 75 Points (PANSS), CGI under a total of 4 points)
- Patients must be able to give consent and need to capable of understanding the declaration of consent (the doctors will check this for each patient)
- smokers (more than 10 cigarettes per day during the last 5 years)
- non-smokers (no consumption of tobacco products over the last 5 years)

Exclusion Criteria

- acute suicidal tendencies or danger of harming others
- seizures or epileptic attacks in the past
- dermatological diseases
- metallic objects inside the head
- pregnancy
- intake of medication against epilepsy or depression
- Stable medication with Benzodiazepine
- addiction to alcohol or substances (not including tobacco)
- Patient has a legal carer who denies approval

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differential effects of cortical excitability and plasticity following a nicotinergic modulation with one dose of Vareniclin.<br>This will be measured with TMS (transcranial magnet Stimulation) 3 hours after the intake of the substance. MEPs (Motor evoked potentials) will be the criterion for change.<br>

Secondary Outcome Measures

Name	Time	Method
Changes in focal and non-focal cortical plasticity in smoking and non-smoking patients with schizophrenia.<br>The changes will be measured after the stimulation in an interval of 10 minutes. A total of 6 post-stimulation measurements will be performed.