Duffel, Belgium
NCT Number: NCT01788436
A Study to Assess Learning Performance in Patients With Schizophrenia and Young and Elderly Healthy Volunteers
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.
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Notify MeKey information
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Early Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Cognitive Test Battery 1
BehavioralThe 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.
Cognitive Test Battery 2
BehavioralThe 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.
Primary outcomes
-
Measurement of implicit and explicit learning through cognitive testing over a period of 7 days
Time frame: 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.
Secondary outcomes
-
Incidence of Adverse Events
Time frame: 7 days
Sponsors and collaborators
Lead sponsor
Janssen Research & Development, LLC
Industry
Registry information
Official study title
An Exploratory Study to Measure and Contrast Implicit and Explicit Learning Performance in Patients With Stable Schizophrenia and Young and Elderly Healthy Subjects
Important dates
- Study start
- 2012
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Feb 11, 2013
- Registry last updated
- Jun 17, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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