Schizophrenia Clinical Trial
Official title:
Nicotine Effects on Endophenotypes of Schizophrenia
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.
Status | Completed |
Enrollment | 121 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn | German Research Foundation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Three hours after patch application | No |
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