Overview
Nicotine Effects on Endophenotypes of Schizophrenia
Status:
Completed
Completed
Trial end date:
2012-03-01
2012-03-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
University Hospital, BonnCollaborator:
German Research FoundationTreatments:
Nicotine
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 (< 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
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