NCT02805088

Brief Summary

The initial aim of the project was to gain an understanding of the comprehension of "language-oriented" emotions among schizophrenic and bipolar patients. By "language-oriented" emotions, the investigators mean the emotions that are conveyed by means of language, whether through the emotional valence of the words, the expression of an emotional state or emotional prosody. Although they involve different diagnostic categories, schizophrenic and bipolar disorders nevertheless share a number of symptoms, in particular in the emotional sphere, and do so to such an extent that the question of whether there may, at the clinical, cognitive and etiopathogenic levels, exist a continuum between these disorders is frequently raised. Taking this hypothesis of a clinical continuum as our starting point, the investigators explored the understanding of emotions contextualized by language in these two clinical populations, namely patients exhibiting schizophrenic and bipolar disorders. To these populations, the investigators also added the dimension of vulnerability in the form of non-clinical participants varying in terms of their traits of schizotypy and hypomania, thus orienting this project toward the early identification of cognitive-emotional markers and possibly also their prevention.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

June 15, 2016

Last Update Submit

June 20, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Event-related brain potentials (ERP)

    within 30 days

Study Arms (3)

Bipolar Disorder patients

EXPERIMENTAL
Other: Electroencephalographic recordingsOther: neuropsychological evaluationOther: clinical evaluation of symptoms

Schizophrenia patients

EXPERIMENTAL
Other: Electroencephalographic recordingsOther: neuropsychological evaluationOther: clinical evaluation of symptoms

Healthy Volunteers

EXPERIMENTAL
Other: Electroencephalographic recordingsOther: neuropsychological evaluationOther: clinical evaluation of symptoms

Interventions

Bipolar Disorder patientsHealthy VolunteersSchizophrenia patients
Bipolar Disorder patientsHealthy VolunteersSchizophrenia patients
Bipolar Disorder patientsHealthy VolunteersSchizophrenia patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

France, Reims, 51092, France

RECRUITING

Related Publications (3)

  • Terrien S, Gobin P, Iakimova G, Coutte A, Thuaire F, Baltazart V, Mazzola-Pomietto P, Besche-Richard C. Electrophysiological correlates of emotional meaning in context in relation to facets of schizotypal personality traits: A dimensional study. Psychiatry Clin Neurosci. 2016 Mar;70(3):141-50. doi: 10.1111/pcn.12366. Epub 2015 Dec 22.

  • Terrien S, Gobin P, Coutte A, Thuaire F, Iakimova G, Mazzola-Pomietto P, Besche-Richard C. Emotional Meaning in Context in Relation to Hypomanic Personality Traits: An ERP Study. PLoS One. 2015 Sep 22;10(9):e0138877. doi: 10.1371/journal.pone.0138877. eCollection 2015.

  • Terrien S, Stefaniak N, Morvan Y, Besche-Richard C. Factor structure of the French version of the Hypomanic Personality Scale (HPS) in non-clinical young adults. Compr Psychiatry. 2015 Oct;62:105-13. doi: 10.1016/j.comppsych.2015.07.001. Epub 2015 Jul 8.

MeSH Terms

Conditions

Bipolar DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Central Study Contacts

Arthur KALADJIAN

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

February 1, 2014

Primary Completion

August 1, 2016

Last Updated

June 21, 2016

Record last verified: 2016-06

Locations