A Study to Assess Learning Performance in Patients With Schizophrenia and Young and Elderly Healthy Volunteers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788436
• Other study ID #: CR100911
• Secondary ID: NOCOMPOUNDEDI000
• Status: Completed
• Phase: Phase 0
• First received: November 8, 2012
• Last updated: June 16, 2014
• Start date: November 2012
• Est. completion date: May 2014

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Cognitive Test Battery 1
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.
• Cognitive Test Battery 2
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

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