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| ID | Type | Description | Link |
|---|---|---|---|
| NOCOMPOUNDEDI0004 | Other Identifier | Janssen Research & Development, LLC |
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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.
This is an exploratory study involving schizophrenic patients (Group 1) and young and elderly healthy volunteers (Group 2 and 3 respectively). No investigational medicinal product will be administered. For all participants enrolled (Group 1 to 3) the study will consist of an eligibility screening examination (from Day -21 up to and including Day 1) and 3 cognitive assessment days. Cognitive assessments will be made on 2 subsequent days (Days 1 and 2) which are separated by overnight sleep. In addition, a session will be performed on Day 7. Completion of the cognitive test batteries can occur at any time during the day provided that the completion time is comparable on all test days. For each participant, the maximal study duration will not exceed 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Patients with schizophrenia | Experimental |
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| Group 2: Young healthy volunteers | Active Comparator |
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| Group 3: Elderly healthy volunteers | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Test Battery 1 | Behavioral | The Cognitive Test Battery 1 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Pattern/Sequence Learning Task (PLT_Impl); Verbal Learning Test (VLT); Figure drawing; Mirror Drawing; Explicit Pattern Learning Task (PLT_Expl); Delayed Recall and Recognition Test; and Pursuit rotor. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duffel | Belgium |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Cognitive Test Battery 2 | Behavioral | The Cognitive Test Battery 2 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Learning Retention Test; Hopkins Verbal Learning Test (HVLT); Figure drawing; Mirror Drawing; Explicit Learning Retention Test; Instrumental Learning Task; Pursuit rotor; and Sensory Motor Interception Adaptation Task. |
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