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Completed

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Duffel, Belgium

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

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

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.

Primary outcomes

  1. 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

  1. 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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