Nicotine Effects on Endophenotypes of Schizophrenia
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|ClinicalTrials.gov Identifier: NCT01315002|
Recruitment Status : Completed
First Posted : March 15, 2011
Results First Posted : January 16, 2015
Last Update Posted : January 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Transdermal nicotine patch Drug: Placebo patch||Not Applicable|
Convergent findings suggest that an altered neuronal nicotinic acetylcholine receptor system may contribute to the pathophysiology of schizophrenia. Nicotine consumption through cigarette smoking might represent a form of self-medication in schizophrenia as nicotine reduces cognitive and physiological deficits in schizophrenia. The present study aims to investigate how nicotine affects attentional and executive schizophrenia endophenotypes and how genetic polymorphisms relating to the cholinergic system might play a role in inter-individual differences in the magnitude of nicotine effects.
Schizophrenia patients, first-degree relatives of schizophrenia patients as well as healthy controls will receive transdermal nicotine in a double-blind, placebo-controlled, crossover study and will be assessed with prepulse inhibition, antisaccades, the continuous performance test, spatial working memory and a verbal memory task. Subjects will be overnight-abstinent smokers and non-smokers. However, the investigators will particularly test non-smokers in order to eliminate confounding effects of nicotine withdrawal and reinstatement.
- Schizophrenia patients will perform worse than matched controls in all cognitive tests (validating our endophenotypes).
- Nicotine administration will enhance cognitive performance in overnight-abstinent smokers.
- Improvement of cognitive performance in smokers with schizophrenia will be stronger than in control smokers.
- Improvement of cognitive performance in smoking first-degree relatives of schizophrenia patients will be stronger than in control smokers.
- Nicotine administration will affect cognitive functioning in non-smoking subjects.
- Nicotine administration will improve cognitive functioning in non-smoking schizophrenia patients.
- The effects of nicotine in non-smoking subjects are stronger in those subjects who are cognitively more impaired (i.e. performing below the median of the respective group).
The present research contributes to the issue whether nicotinic cholinergic receptor agonists may have therapeutic value in the treatment of cognition in schizophrenia.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Nicotine Effects on Endophenotypes of Schizophrenia|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Active Comparator: Nicotine Patch
Transdermal nicotine patch
Drug: Transdermal nicotine patch
7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)
Other Name: NiQuitin Clear, GlaxoSmithKline Germany
Placebo Comparator: Placebo patch
Drug: Placebo patch
Other Name: band-aid by Fink and Walter GmbH, Germany
- Error Percentage in Antisaccade Task [ Time Frame: Three hours after patch application ]Three hours after the application of a nicotine or a placebo patch, performance on the antisaccade task is assessed. In the antisaccade task participants visually fixate a central stimulus which is replaced by a sudden onset target that appears at some distance to the left or right. Participants are told to refrain from looking at the peripheral target, and direct their gaze instead in the opposite direction (i.e. they have to make an antisaccade). Participants typically fail to achieve this on a significant number of trials and instead make reflexive glances towards the target (i.e. making a so-called antisaccade error). Error percentage in the antisaccade task is the unit of measure in this task. Error percentage in the antisaccade task = number of antisaccade errors / total number of trials.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315002
|Principal Investigator:||Michael Wagner, Prof. Dr.||University Hospital, Bonn|
|Principal Investigator:||Wolfgang Maier, Prof. Dr.||University Hospital, Bonn|