N/A
N=121
Nicotine Effects on Endophenotypes of Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01315002 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Error Percentage in Antisaccade Task — 22.6; 29.1 Error Percentage in Antisaccade Task — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transdermal nicotine patch (Drug); Placebo patch (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Bonn
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Error Percentage in Antisaccade Task |
22.6; 29.1 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
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
- smokers (Fagerström Test for Nicotine Dependence > 4)
- non-smokers ( 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
Exclusion Criteria
Patients:
- substance dependence
- clinical instability
- changes in medication in the last 6 weeks
- 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
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
Data sourced from ClinicalTrials.gov (NCT01315002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.