NCT04561622

Brief Summary

The main objective of this project is to identify behavioral specificities of the proactive emotional brain among bipolar patients, compared to healthy subjects. These could contribute to some of the emotional processing biases that can be observed in these patients. To achieve this goal, two behavioral tasks will be administer (emotional stroop and emotional stimuli categorization task) to bipolar patients and control subjects, and their performances will be compared.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

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

First Submitted

Initial submission to the registry

August 12, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

August 12, 2020

Last Update Submit

May 17, 2022

Conditions

Bipolar DisorderBipolar I DisorderBipolar II Disorder

Keywords

bipolar disorderemotioncognitionstroopproactive emotional processing

Outcome Measures

Primary Outcomes (1)

  • performances at the emotional Stroop task

    percentage of correct answers ( in %), reaction time ( in seconds) and inverse efficiency score ( N.A)

    day1

Secondary Outcomes (3)

  • sensitivity to interference during Stroop tasks

    day1

  • Effect of mood state (depressive state) on behavioral tasks' performances

    day 1

  • Effect of mood state (hypo/manic state) on behavioral tasks' performances

    day 1

Study Arms (2)

Bipolar patients

Bipolar patients (type I,II, NOS) of the bipolar disorder expert center of CHU Grenoble Alpes.

Behavioral: Emotional Stroop Task

Healthy controls

Volunteers without any psychiatric disease matching inclusion criteria

Behavioral: Emotional Stroop Task

Interventions

Emotional Stroop TaskBEHAVIORAL

Classic Stroop task The subject names one of the 3 colors of the crosses on a sheet.Then, the subject must read the words written on the sheet for 45 seconds.These are the words: RED, BLUE and GREEN, written in black color. The subject must name the color of the word. Emotional Stroop task This is a computed task in which the patient is asked to answer both as accurately and as quickly as possible. The target stimulus is an emotional face of joy or anger, surmounted by the word "joy" or "anger".The subject must respond using the arrow corresponding to the face he sees. A training phase is offered to the subject. 3 / Categorization task For each trial the participant will visualize a short emotional film or not. Then, the participant will have to choose, the emotion corresponding to what he just saw. A training period is offered too.

Also known as: Classic Stroop Task, Categorization of Emotional Stimuli Task
Bipolar patientsHealthy controls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

bipolar patients cohort followed-up in the Expert Center of University Hospital of Grenoble

You may qualify if:

  • Right-handed
  • Francophones
  • Bipolar disorder diagnosis (for patients) according to DSM-5 / CIM-10 criteria
  • Affiliation to the French social security insurance

You may not qualify if:

  • uncorrected perceptual disturbance
  • psychiatric disorders other than bipolarity as the main psychiatric disorder or a condition which may affect the tasks proposed for the patients' group
  • subject under legal protection
  • subject deprived of freedoms by a judicial or administrative decision
  • drug abuse less than 12 hours before the assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

La Tronche, Isère, 38 700, France

Location

Related Publications (2)

  • Beffara B, Wicker B, Vermeulen N, Ouellet M, Bret A, Molina MJ, Mermillod M. Reduction of interference effect by low spatial frequency information priming in an emotional Stroop task. J Vis. 2015;15(6):16. doi: 10.1167/15.6.16.

    PMID: 26024463BACKGROUND

  • Golden, C. (1978). Diagnosis and Rehabilitation in Clinical Neuropsychology. College of Psychology: Faculty Books and Book Chapters. https://nsuworks.nova.edu/cps_facbooks/48

    BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Mircea Polosan, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

September 23, 2020

Study Start

October 1, 2020

Primary Completion

June 1, 2021

Study Completion

October 1, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

FR(1)