Schizophrenia Clinical Trial
Official title:
An Exploratory Study to Measure and Contrast Implicit and Explicit Learning Performance in Patients With Stable Schizophrenia and Young and Elderly Healthy Subjects
Verified date | June 2014 |
Source | Janssen Research & Development, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to measure and contrast implicit and explicit learning performance in patients with schizophrenia relative to young and elderly healthy volunteers.
Status | Completed |
Enrollment | 51 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Group 1 (patients with schizophrenia): - Be a man or woman between 18 and 55 years of age, inclusive - Has a known history of schizophrenia of at least 12 months by the referring psychiatrist - Receives stable antipsychotic drug therapy (maximally 2) for at least 6 weeks prior to screening - Medically stable on the basis of clinical judgment by the investigator - Group 2 (young healthy volunteers): be a healthy man or woman between 18 and 55 years of age, inclusive - Group 3 (elderly healthy volunteers): be a healthy man or woman between 65 and 85 years of age, inclusive - All participants (Group 1 to 3) must be capable of completing the cognitive test battery Exclusion Criteria: - Receives treatment with benzodiazepines, tricyclic antidepressant or anticholinergics - Has a positive urine screen for drugs of abuse or alcohol breath test - Has a recent history (within previous 6 months) of alcohol or drug abuse - Has psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the participant to comply with the study requirements - Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the participant or the study or prevent the participant from meeting or performing study requirements - Group 1 only: a diagnosis of substance dependence within 3 months prior to screening evaluation (patient with a positive drug screen at screening may be included provided use does not lead to a diagnosis of substance dependence and patient consents to abstain from illegal drugs at any time during the study) |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of implicit and explicit learning through cognitive testing over a period of 7 days | The cognitive data will be summarized and summary statistics calculated (including mean, standard deviation, median, minimum, and maximum values) for each experiment and participants group. | 7 days | No |
Secondary | Incidence of Adverse Events | 7 days | No |
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