Bipolar DisorderPROEMO_BPNCT04561622
Emotional Proactive Processing in Bipolar Disorder
An observational study of Bipolar Disorder and Bipolar I Disorder, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder
- What is being tested?
- Emotional Stroop Task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: bipolar patients cohort followed-up in the Expert Center of University Hospital of Grenoble
Who may be able to join
- Right-handed
- Francophones
- Bipolar disorder diagnosis (for patients) according to DSM-5 / CIM-10 criteria
- Affiliation to the French social security insurance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder
- Being tested
- Emotional Stroop Task
- Keywords
- bipolar disorder, emotion, cognition, stroop, proactive emotional processing
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Stroop TaskBehavioural
Also called Classic Stroop Task, Categorization of Emotional Stimuli 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.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar patients | Bipolar patients (type I,II, NOS) of the bipolar disorder expert center of CHU Grenoble Alpes. Receives: Behavioral: Emotional Stroop Task | |
| Healthy controls | Volunteers without any psychiatric disease matching inclusion criteria Receives: Behavioral: Emotional Stroop Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
performances at the emotional Stroop task
percentage of correct answers ( in %), reaction time ( in seconds) and inverse efficiency score ( N.A)
Measured: day1
Secondary outcomes (3)
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)
Measured: day1
Effect of mood state (depressive state) on behavioral tasks' performances
assessment of the impact of mood scales (MADRS) scores on behavioral tasks performances
Measured: day 1
Effect of mood state (hypo/manic state) on behavioral tasks' performances
assessment of the impact of mood scales (YMRS) scores on behavioral tasks performances
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Jun 2021
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mircea Polosan, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561622
- Sponsor's protocol ID
- 38RC19.387
- Other IDs
- 2019-A03026-51
- Acronym
- PROEMO_BP
- Status last verified
- May 2022
- First submitted
- 12 Aug 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the patient accepts all the characteristics useful for the study will be available in our results.
Publications
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.
PubMed 26024463Golden, C. (1978). Diagnosis and Rehabilitation in Clinical Neuropsychology. College of Psychology: Faculty Books and Book Chapters. https://nsuworks.nova.edu/cps_facbooks/48
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Proactive Processing in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT04561622
- Acronym / sponsor ID
- PROEMO_BP / 38RC19.387
- Conditions
- Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder
- Keywords
- bipolar disorder, emotion, cognition, stroop, proactive emotional processing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar patients | – | Behavioral: Emotional Stroop TaskBipolar patients (type I,II, NOS) of the bipolar disorder expert center of CHU Grenoble Alpes. |
| Healthy controls | – | Behavioral: Emotional Stroop TaskVolunteers without any psychiatric disease matching inclusion criteria |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- bipolar patients cohort followed-up in the Expert Center of University Hospital of Grenoble
Key inclusion criteria (4 listed)
- Right-handed
- Francophones
- Bipolar disorder diagnosis (for patients) according to DSM-5 / CIM-10 criteria
- Affiliation to the French social security insurance
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Stroop TaskAlso: Classic Stroop Task, Categorization of Emotional Stimuli TaskClassic 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. | Behavioural | Bipolar patients, Healthy controls |
Primary outcome
performances at the emotional Stroop task
Time frame: day1
percentage of correct answers ( in %), reaction time ( in seconds) and inverse efficiency score ( N.A)
3 secondary outcomes
sensitivity to interference during Stroop tasks
Time frame: day1
Effect of mood state (depressive state) on behavioral tasks' performances
Time frame: day 1
Effect of mood state (hypo/manic state) on behavioral tasks' performances
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 26024463Beffara 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.
- BackgroundGolden, C. (1978). Diagnosis and Rehabilitation in Clinical Neuropsychology. College of Psychology: Faculty Books and Book Chapters. https://nsuworks.nova.edu/cps_facbooks/48
- Individual participant dataSharing planned: Undecided. If the patient accepts all the characteristics useful for the study will be available in our results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mircea Polosan, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Bipolar I Disorder, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performances at the emotional Stroop task (time frame: day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04561622, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.