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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04561622
Other study ID # 38RC19.387
Secondary ID 2019-A03026-51
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date October 1, 2022

Study information

Verified date May 2022
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This is a case-control non-interventional study comparing bipolar patients to matched healthy controls during one assessment visit at the University Hospital of Grenoble. The experimentation phase takes place in three stages: first, the experimenter collects demographic data (age and level of study, lack of medical history and treatments that may interfere with the task). For bipolar subjects, it also collects the type of bipolarity, the type and date of the last episode, the age of the onset of the disease and the treatment. Secondly, the subject performs a classic Stroop task lasting 3 to 5 minutes, including instructions. Finally, the subject performs the two main tasks: the emotional Stroop task lasting about 20 minutes and then the task of emotional stimuli categorization lasting about 15 minutes.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date October 1, 2022
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Right-handed - Francophones - Bipolar disorder diagnosis (for patients) according to DSM-5 / CIM-10 criteria - Affiliation to the French social security insurance Exclusion Criteria: - 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

Study Design


Intervention

Behavioral:
Emotional Stroop Task
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.

Locations

Country Name City State
France CHU Grenoble Alpes La Tronche Isère

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary performances at the emotional Stroop task percentage of correct answers ( in %), reaction time ( in seconds) and inverse efficiency score ( N.A) day1
Secondary sensitivity to interference during Stroop tasks -reaction time (in seconds) in the different conditions of the task (reading in the congruent condition, interference during the incongruent condition) day1
Secondary Effect of mood state (depressive state) on behavioral tasks' performances assessment of the impact of mood scales (MADRS) scores on behavioral tasks performances day 1
Secondary Effect of mood state (hypo/manic state) on behavioral tasks' performances assessment of the impact of mood scales (YMRS) scores on behavioral tasks performances day 1
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