Clinical trial NCT01788436: A Study to Assess Learning Performance in Patients With Schizophrenia and Young and Elderly Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Keywords: Schizophrenia
Young healthy volunteers
Elderly healthy volunteers
Learning performance
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-02-11
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Measurement of implicit and explicit learning through cognitive testing over a period of 7 days
timeFrame: 7 days
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: 7 days
Other outcomes:
Locations:
city: Duffel
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: