NCT02896374

Brief Summary

Case-control comparison of clinical population, interventional and single-center research.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2013

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

4.3 years

First QC Date

August 19, 2016

Last Update Submit

March 21, 2018

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Event related electric amplitudes

    Scalp EEG recordings (microvolts) with respect to average or vertex references

    Day 0

Study Arms (2)

Patients

EXPERIMENTAL

Treated or hospitalized patients for schizophrenia.

Behavioral: Theory of mind without visual cues

Control

EXPERIMENTAL

No schizophrenic participants, comparable to schizophrenia patients in age, gender, education level and socio premorbid verbal IQ.

Behavioral: Theory of mind without visual cues

Interventions

Theory of mind without visual cuesBEHAVIORAL

Theory of mind stimulation without visual reinforcement while performing EEG recordings

ControlPatients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent French mother tongue Schizophrenia diagnosis according to DSM-IV-R for the patient group

You may not qualify if:

  • Coma history, epilepsy, head trauma with loss knowledge greater 10 min ECT older than 1 month DSM-4 R criteria of toxic addiction in the last 6 months Deafness or blindness Scalp pathology Intracranial implanted device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Eric Brunet, MD PhD

    Versailles Hospital

    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
PRINCIPAL INVESTIGATOR
PI Title
Investigator coordinator

Study Record Dates

First Submitted

August 19, 2016

First Posted

September 12, 2016

Study Start

March 1, 2013

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

FR(1)