Overview

Nicotine Effects on Endophenotypes of Schizophrenia

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University Hospital, Bonn
Collaborator:
German Research Foundation
Treatments:
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