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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013735
Enrollment
144
Registered
2018-01-10
Start date
2018-01-22
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F20

Interventions

Group 1: Each arm stands for one experiment. Pat. can participate in several experiments after a 14 days break. Any experiment contains one measurement with Placebo and one with vareniclin. The two me

Sponsors

Klinik für Psychiatrie und Psychotherapie- Klinikum der Universität München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Differential effects of cortical excitability and plasticity following a nicotinergic modulation with one dose of Vareniclin. 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.

Secondary

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

Countries

Germany

Contacts

Public ContactBenjamin Pross

Bezirkskrankenhaus Augsburg, Klinik für Psychiatrie und Psychotherapie der Universität Augsburg

Benjamin.Pross@med.uni-muenchen.de082148031600

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026