NCT02782091

Brief Summary

Schizophrenia (SZ) is a chronic, severe disease resulting in a misperception of reality, major social withdrawal and cognitive disturbances. Executive dysfunctions are widely considered as primary determinants of functional outcome. However, classic neuropsychological executive function measures poorly represent patients' functional outcome and seem inappropriate to evaluate the real-world functional impact of the disease. In this perspective, Shallice and Burgess have developed for brain-damaged patients, the Multiple Errands Test (MET) allowing to assess planning, adaptation, problem solving and mental flexibility in real life settings, thus better capturing day-to-day abilities and including contextual (social, perceptive) influences. Setting the assessment outside the laboratory can help to identify subtle executive impairment not systematically expressed in standard care conditions and consequently improve the future care solutions. MET is based on the Supervisory Attentional System model of executive functioning and attention control that specifies how thought and action schema become activated or suppressed for routine and non-routine circumstances. MET has been designed to measure real-world executive performance confronting the participants to unpredictable affordances and interpersonal interactions while planning and problem solving. Patients are asked to accomplish several tasks of variable complexity in an unknown commercial district. Severals rules must be respected and thus an action plan, strategy formulation, time and space management with very little assistance of the examiner are required. Most of the studies involving MET were conceived for patients with acquired brain damage. LeThiec offered an extensive protocol with the initial scoring system (in terms of inefficiencies, rule breaks, interpretation failures and task execution failures). Simplified versions of MET were also suggested to be more suitable in hospital settings. Only one study was done in SZ including a single patient, it is therefore difficult to draw conclusions about clinical utility in SZ. To date, no other studies investigated the suitability of MET in patients with psychosis, while executive impairment is well documented in this population The investigators hypothesized that the Multiple Errands Test (MET), an ecological assessment of executive function has a better ability to measure everyday adaptative functioning SZ, compared to conventional EF assessment methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

June 16, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

3.6 years

First QC Date

May 17, 2016

Last Update Submit

March 29, 2023

Conditions

Keywords

METPrognosisCognitionEcologicalExecutive function

Outcome Measures

Primary Outcomes (1)

  • Comparison of quantitative variable between score for MET and standard functional evaluation

    Inclusion visit

Study Arms (2)

Schizophrenia Patient

EXPERIMENTAL
Behavioral: Multiple Errands Test (MET)

Control Subject

EXPERIMENTAL
Behavioral: Multiple Errands Test (MET)

Interventions

1 hour assessment in an unknown district with 2 independent raters.

Also known as: Errands Test (Shallice and Burgess, 1991)
Control SubjectSchizophrenia Patient

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Experimental group
  • Diagnosis of schizophrenia or schizoaffective disorder (DSM V criteria)
  • Clinically stable
  • Age : between18 and 50 years
  • Social security affiliation
  • French speakers
  • Written consent signed
  • Control group
  • Age : between18 and 50 years
  • Social security affiliation
  • French speakers
  • Written consent signed

You may not qualify if:

  • History of neurological or somatic disorders with sensori-motor impact
  • Electroconvulsive therapy in the 6 months prior to participation
  • Person living near the test site and/or knowing the neighborhood
  • Person under guardianship
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Franck SCHURHOFF, Prof, MD.

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 25, 2016

Study Start

June 16, 2016

Primary Completion

January 21, 2020

Study Completion

January 21, 2020

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations