Emotional Proactive Processing in Bipolar Disorder

• Conditions: Bipolar II Disorder; Bipolar Disorder; Bipolar I Disorder
• Interventions: Behavioral: Emotional Stroop Task

• Registration Number: NCT04561622
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-10-01
• Primary Completion: 2021-06-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bipolar patients	Emotional Stroop Task	Bipolar patients (type I,II, NOS) of the bipolar disorder expert center of CHU Grenoble Alpes.
Healthy controls	Emotional Stroop Task	Volunteers without any psychiatric disease matching inclusion criteria

Primary Outcome Measures

Name	Time	Method
performances at the emotional Stroop task	day1	percentage of correct answers ( in %), reaction time ( in seconds) and inverse efficiency score ( N.A)

Secondary Outcome Measures

Name	Time	Method
Effect of mood state (hypo/manic state) on behavioral tasks' performances	day 1	assessment of the impact of mood scales (YMRS) scores on behavioral tasks performances
Effect of mood state (depressive state) on behavioral tasks' performances	day 1	assessment of the impact of mood scales (MADRS) scores on behavioral tasks performances
sensitivity to interference during Stroop tasks	day1	-reaction time (in seconds) in the different conditions of the task (reading in the congruent condition, interference during the incongruent condition)

Trial Locations

Locations (1)

CHU Grenoble Alpes; 🇫🇷 La Tronche, Isère, France