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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 4 July 2016
Main ID:  NCT02805088
Date of registration: 15/06/2016
Prospective Registration: No
Primary sponsor: CHU de Reims
Public title: Emotions in Schizophrenia and Bipolar Disorders: a Common Vulnerability? ELISE
Scientific title: Interaction Emotion-cognition in the Study of Literal and Figurative Language in Schizophrenia and Bipolar Disorders: Behavioral and Electrophysiological Studies
Date of first enrolment: February 2014
Target sample size: 240
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02805088
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Arthur KALADJIAN
Address: 
Telephone: 326787045
Email: akaladjian@chu-reims.fr
Affiliation: 
Name:     Damien JOLLY
Address: 
Telephone: 326788472
Email: djolly@chu-reims.fr
Affiliation: 
Key inclusion & exclusion criteria

Inclusion criteria

Patients :

Men or women, right-handed, with a diagnosis of bipolar disorder or schizophrenia,
according to the DSM-IV criteria, aged from 18 to 65 years-old Native French speaker
Clinically stabilised Able to provide informed written and verbal consent

Healthy Controls :

Men or women, right-handed, aged from 18 to 65 years-old Native French speaker Able to
provide informed written and verbal consent

Exclusion criteria

Patients :

A recent alcohol and/or drug abuse or dependence A significant general medical illness,
including neurological disorders or head trauma A sensorial impairment (visual and/or
hearing)

Healthy Controls :

A personal or first-degree-relative history of bipolar disorder, schizophrenia or
schizoaffective disorder according to DSM-IV A recent alcohol and/or drug abuse or
dependence A significant general medical illness, including neurological disorders or head
trauma A sensorial impairment (visual and/or hearing)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Schizophrenia
Bipolar Disorder
Intervention(s)
Other: clinical evaluation of symptoms
Other: Electroencephalographic recordings
Other: neuropsychological evaluation
Primary Outcome(s)
Event-related brain potentials (ERP) [Time Frame: within 30 days]
Secondary Outcome(s)
Secondary ID(s)
PO13116
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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