- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853019
Emotion and Motivation in Patients With Psychosis
August 18, 2023 updated by: University Hospital, Strasbourg, France
Influence of Emotion and Motivation on Behaviour and Neural Activity in Patients With Psychosis
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anne GIERSCH
- Phone Number: 03 88 11 64 71
- Email: giersch@unistra.fr
Study Locations
-
-
-
Strasbourg, France, 67091
- Recruiting
- Unité INSERM 1114
-
Sub-Investigator:
- Pierre VIDAILHET, MD, PhD
-
Sub-Investigator:
- Fabrice BERNA, MD, PhD
-
Contact:
- Anne GIERSCH, MD, PhD
- Phone Number: 03 88 11 64 71
- Email: giersch@unistra.fr
-
Principal Investigator:
- Anne GIERSCH, MD, PhD
-
Sub-Investigator:
- Laurence LALANNE, MD, PhD
-
Sub-Investigator:
- Sébastien WEIBEL, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia
Exclusion Criteria:
- addiction problem
- invalidating visual sensory problems
- neurological history
- for the healthy volunteers: psychiatric history
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with schizophrenia
|
electrophysiological measurements (evoked potentials) based on neural activity when visualizing stimuli
- clinical scales and subjective assessments of emotional and motivational stimuli
- clinical scales and subjective assessments of emotional and motivational stimuli
|
Sham Comparator: Healthy volunteers
|
electrophysiological measurements (evoked potentials) based on neural activity when visualizing stimuli
- clinical scales and subjective assessments of emotional and motivational stimuli
- clinical scales and subjective assessments of emotional and motivational stimuli
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the amplitude of the CNV (Contingent Negative Variation) as a function of the primer displayed on the screen
Time Frame: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the amplitude of the LPP (Late Positive Potential) as a function of the primer displayed on the screen
Time Frame: During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
|
The investigators will check whether primers affect the subjects attention by measuring the LPP, which is an evoked potential recorded with electroencephalography, and indexing sustained attention.
|
During EEG sessions, at experimental session 1 (Day 0) and experimental session 2 (up to Day 120)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2017
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
May 23, 2016
First Submitted That Met QC Criteria
July 28, 2016
First Posted (Estimated)
August 2, 2016
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 18, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6152
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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