Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT01315002
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2011-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotine Effects on Endophenotypes of Schizophrenia
Sponsor:
University Hospital, Bonn
Organization:
Study Overview
Official Title:
Nicotine Effects on Endophenotypes of Schizophrenia
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the effects of nicotine on cognition with the following schizophrenia endophenotypes: prepulse inhibition, antisaccades, the continuous performance test, spatial working memory and a verbal memory task. Schizophrenia patients, unaffected first-degree relatives of schizophrenia patients and healthy controls receive transdermal nicotine in a double-blind, placebo-controlled, crossover study.
Detailed Description:
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.
Main hypotheses:
* 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.
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.
Main hypotheses:
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2008-001362-90 | EUDRACT_NUMBER | None | View |