SchizophreniaNCT01315002
Nicotine Effects on Endophenotypes of Schizophrenia
A study testing Transdermal nicotine patch in people with Schizophrenia, run by University Hospital, Bonn.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Transdermal nicotine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients:
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) diagnosis of schizophrenia
- age 18-55 years old
- able to provide informed consent
- treated with antipsychotic medications at a stable dose for at least 6 weeks
- normal or corrected to normal vision
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- smokers (Fagerström Test for Nicotine Dependence > 4)
- non-smokers (< 100 cigarettes/lifetime, not having smoked in the past year)
- Controls:
- age 18-55 years old
- able to provide informed consent
- normal or corrected to normal vision
- smokers (Fagerström Test for Nicotine Dependence > 4)
- non-smokers (< 100 cigarettes/lifetime, not having smoked in the past year)
- Unaffected First-Degree Relatives of Schizophrenia Patients:
- same inclusion criteria as controls plus
- having an adult first-degree relative (sibling, parent, child) with a DSM IV diagnosis of schizophrenia
Who cannot join
- Patients:
- substance dependence
- clinical instability
- changes in medication in the last 6 weeks
- anticholinergic medication
- untreated hypertension
Show all 38Show fewer
- cardiovascular disease
- insulin-dependent diabetes mellitus
- phaeochromocytoma
- uncontrolled hyperthyroidism
- renal or hepatic impairment
- central nervous system disease
- pulmonary disease
- generalised dermatological disorders (neurodermatitis, psoriasis, chronic dermatitis, urticaria, etc.)
- gastric or intestinal ulcer
- hypersensitivity to nicotine
- allergy to patches
- women: pregnancy, lactation
- Controls:
- substance dependence
- having a first-, second-, or third-degree relative with a psychotic disorder
- DSM IV Axis I disorder
- anticholinergic medication
- untreated hypertension
- cardiovascular disease
- insulin-dependent diabetes mellitus
- phaeochromocytoma
- uncontrolled hyperthyroidism
- renal or hepatic impairment
- central nervous system disease
- pulmonary disease
- generalised dermatological disorders (neurodermatitis, psoriasis, chronic dermatitis, urticaria, etc.)
- gastric or intestinal ulcer
- hypersensitivity to nicotine
- allergy to patches
- women: pregnancy, lactation
- Unaffected First-Degree Relatives of Schizophrenia Patients:
- same exclusion criteria as controls
About this study
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Transdermal nicotine patch, Placebo patch
- Keywords
- nicotine, schizophrenia, endophenotype
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal nicotine patchDrug
Also called NiQuitin Clear, GlaxoSmithKline Germany
7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)
Placebo patchDrug
Also called band-aid by Fink and Walter GmbH, Germany
Placebo patch
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Patch | Active comparator | Transdermal nicotine patch Receives: Drug: Transdermal nicotine patch |
| Placebo patch | Placebo comparator | Placebo patch Receives: Drug: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error Percentage in Antisaccade Task
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.
Measured: Three hours after patch application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJul 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Nadine Petrovsky, University Hospital, Bonn
- Investigators
- Michael Wagner, Prof. Dr., Principal investigator, University Hospital, BonnWolfgang Maier, Prof. Dr., Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315002
- Sponsor's protocol ID
- NICSZ001
- Other IDs
- 2008-001362-90, 2008
- Status last verified
- Jan 2015
- First submitted
- 14 Mar 2011
- Last updated
- 16 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Effects on Endophenotypes of Schizophrenia
- ClinicalTrials.gov ID
- NCT01315002
- Acronym / sponsor ID
- NICSZ001
- Conditions
- Schizophrenia
- Keywords
- nicotine, schizophrenia, endophenotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jul 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Posted 16 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Patch | Active comparator | Drug: Transdermal nicotine patchTransdermal nicotine patch |
| Placebo patch | Placebo comparator | Drug: Placebo patchPlacebo patch |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) diagnosis of schizophrenia
- age 18-55 years old
- able to provide informed consent
- treated with antipsychotic medications at a stable dose for at least 6 weeks
- normal or corrected to normal vision
Key exclusion criteria (38 listed)
- substance dependence
- clinical instability
- changes in medication in the last 6 weeks
- anticholinergic medication
- untreated hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal nicotine patchAlso: NiQuitin Clear, GlaxoSmithKline Germany7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects) | Drug | Nicotine Patch |
| Placebo patchAlso: band-aid by Fink and Walter GmbH, GermanyPlacebo patch | Drug | Placebo patch |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wagner, Prof. Dr. principal investigator
University Hospital, Bonn
Wolfgang Maier, Prof. Dr. principal investigator
University Hospital, Bonn
Questions about this trial
What is this clinical trial studying?
A study testing Transdermal nicotine patch in people with Schizophrenia, run by University Hospital, Bonn.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error Percentage in Antisaccade Task (time frame: Three hours after patch application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.