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

NCT ID: NCT01788436

Last Updated: 2014-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-05-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Group 1: Patients with schizophrenia

Group Type: EXPERIMENTAL

Cognitive Test Battery 1

Intervention Type: 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.

Cognitive Test Battery 2

Intervention Type: 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.

Group 2: Young healthy volunteers

Group Type: ACTIVE_COMPARATOR

Cognitive Test Battery 1

Intervention Type: 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.

Cognitive Test Battery 2

Intervention Type: 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.

Group 3: Elderly healthy volunteers

Group Type: EXPERIMENTAL

Cognitive Test Battery 1

Intervention Type: 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.

Cognitive Test Battery 2

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Duffel, , Belgium

Countries

Belgium

Other Identifiers

NOCOMPOUNDEDI0004

Identifier Type: OTHER

Identifier Source: secondary_id

CR100911

Identifier Type: -

Identifier Source: org_study_id