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

An Exploratory Study to Measure and Contrast Implicit and Explicit Learning Performance in Patients With Stable Schizophrenia and Young and Elderly Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Cognitive Test Battery 1; Behavioral: Cognitive Test Battery 2

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Duffel, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Patients with schizophrenia	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.; Behavioral: 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.
Active Comparator: Group 2: Young healthy volunteers	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.; Behavioral: 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.
Experimental: Group 3: Elderly healthy volunteers	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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events	7 days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 8, 2012
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 17, 2014
• Last Update Submitted That Met QC Criteria: June 16, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Schizophrenia; Young healthy volunteers; Elderly healthy volunteers; Learning performance
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CR100911; NOCOMPOUNDEDI0004 (Other Identifier: Janssen Research & Development, LLC)