NCT01788436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for early_phase_1 schizophrenia

Timeline
Completed

Started Nov 2012

Shorter than P25 for early_phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

1.5 years

First QC Date

November 8, 2012

Last Update Submit

June 16, 2014

Conditions

Schizophrenia

Keywords

SchizophreniaYoung healthy volunteersElderly healthy volunteersLearning performance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of Adverse Events

    7 days

Study Arms (3)

Group 1: Patients with schizophrenia

EXPERIMENTAL
Behavioral: Cognitive Test Battery 1Behavioral: Cognitive Test Battery 2

Group 2: Young healthy volunteers

ACTIVE COMPARATOR
Behavioral: Cognitive Test Battery 1Behavioral: Cognitive Test Battery 2

Group 3: Elderly healthy volunteers

EXPERIMENTAL
Behavioral: Cognitive Test Battery 1Behavioral: Cognitive Test Battery 2

Interventions

Cognitive Test Battery 1BEHAVIORAL

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.

Group 1: Patients with schizophreniaGroup 2: Young healthy volunteersGroup 3: Elderly healthy volunteers
Cognitive Test Battery 2BEHAVIORAL

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 1: Patients with schizophreniaGroup 2: Young healthy volunteersGroup 3: Elderly healthy volunteers

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Duffel, Belgium

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2012

First Posted

February 11, 2013

Study Start

November 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

BE(1)