NCT02853019

Brief Summary

Anhedonia and avolition reflect emotional and motivational disorders, respectively. However, if these disorders play a major role in the symptomatology of schizophrenia, their mechanisms remain poorly understood, and existing treatments are inefficient on these symptoms. The literature suggests that the impairment does not concern emotion or motivation per se, but rather their influence on cognition. This project aims at using recent advances in the fundamental domain to better understand the cognitive and neuronal mechanisms of the patients' alterations, and especially how emotion and motivation influence cognition in schizophrenia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 23, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2024

Enrollment Period

8.3 years

First QC Date

May 23, 2016

Last Update Submit

August 18, 2025

Conditions

Keywords

Emotionmotivationcognitionschizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change in the amplitude of the CNV (Contingent Negative Variation) as a function of the primer displayed on the screen

    Before each cognitive trial a primer will be displayed, which will be either neutral or convey emotion or motivation. The investigators will check whether this primer affects the subjects preparation by measuring the CNV, which is an evoked potential recorded with electroencephalography, and indexing preparatory effort.

    During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)

Secondary Outcomes (1)

  • Change in the amplitude of the LPP (Late Positive Potential) as a function of the primer displayed on the screen

    During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)

Study Arms (2)

Healthy volunteers

SHAM COMPARATOR

Healthy volunteers

Other: ElectroencephalogramBehavioral: Cognitive tasksBehavioral: subjective evaluation scales

Patients with schizophrenia

EXPERIMENTAL

Patients with schizophrenia

Other: ElectroencephalogramBehavioral: Cognitive tasksBehavioral: subjective evaluation scales

Interventions

electrophysiological measurements (evoked potentials) based on neural activity when visualizing stimuli

Healthy volunteersPatients with schizophrenia
Cognitive tasksBEHAVIORAL

\- clinical scales and subjective assessments of emotional and motivational stimuli

Healthy volunteersPatients with schizophrenia

\- clinical scales and subjective assessments of emotional and motivational stimuli

Healthy volunteersPatients with schizophrenia

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia

You may not qualify if:

  • addiction problem
  • invalidating visual sensory problems
  • neurological history
  • for the healthy volunteers: psychiatric history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité INSERM 1114

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

May 23, 2016

First Posted

August 2, 2016

Study Start

February 2, 2017

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

August 19, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations