Functional Magnetic Resonance Imaging Study of Inhibitory Control in Bipolar Disorder and Major Depressive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCHU de Reims
About this trial
Bipolar disorder and unipolar depressive disorder are two chronic mood disorders associated with a significant social impact, even during euthymic phases. Their differential diagnosis remains complex, particularly when bipolar disorder begins with a depressive episode. Identifying distinctive markers between these pathologies therefore represents a major clinical and economic challenge, as appropriate mood-stabilizing treatment can reduce healthcare costs and improve patients' functional outcomes.
Among potential biomarkers, executive functions-and more specifically inhibition-have received particular attention. Inhibitory deficits are observed in both disorders, including during euthymic states, and also among first-degree relatives, suggesting their potential as cognitive and cerebral endophenotypes. These deficits may help explain the difficulties in emotion regulation and impulsivity frequently observed in mood disorders.
Two components of inhibition are distinguished:
1. Behavioral inhibition, which refers to the ability to stop an ongoing response. 2. Interference control, which refers to the ability to resist distraction. These processes rely on partially distinct neural networks and operate at different stages of information processing. The few studies comparing these two components in bipolar disorder have shown contradictory results, and neuroimaging investigations have only partially explored these mechanisms, particularly their emotional dimension. It is, however, well established that patients with bipolar or depressive disorders show greater difficulties in executive tasks involving emotional stimuli than in purely cognitive tasks.
The study is expected to reveal:
* Differences in brain activation between euthymic bipolar and unipolar depressive patients in regions involved in inhibitory control, modulated by the emotional content of the task. * Distinct cognitive performance profiles according to pathology, reflecting specific alterations in inhibitory and interference processes.
These findings should provide a better understanding of the differential neurocognitive bases of mood disorders. Identifying specific cognitive and neural profiles could contribute to more accurate differential diagnosis and to the personalization of therapeutic interventions, particularly through cognitive remediation strategies targeting executive and emotional deficits.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients between 18 and 65 years old, men or women, right-handed
Having a diagnosis of bipolar disorder or depressive disorder
No substantial change in treatment for 2 weeks preceding study enrollment
Being a native French speaker
Disqualifiers
The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence
A significant general medical illness, including neurological disorders or head trauma
Contraindication to the use of MRI
A sensorial impairment uncorrected (visual and/or hearing)
Trial design
Design model
Parallel
Treatments tested in this trial
Analysis of inhibitory control
BehavioralInvestigation of neurofunctional characterization of inhibitory control using a comprehensive clinical, cognitive assessment and task-based MRI exams
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Group 1: Bipolar patientsExperimental treatment 1 intervention
Group B: Group 2: Major depressive patientsExperimental treatment 1 intervention
Group C: Group 3: Bipolar controlsActive comparator 1 intervention
Group D: Group 4: Depressive controlsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
fMRI activations during an behavioral inhibition task (emotional stop signal task)
Participants will perform a gender discrimination task on emotional and non-emotional faces. Under Go conditions, the participant must respond. Under non-Go conditions, the frame of the image changes color and the participant must not respond. The faces express neutrality (50%) or anger (50%).
Time frame
Day 02
fMRI activations during an emotional interference control (emotional Flanker task)
Participants were instructed to discriminate the gender of a target stimulus during an emotional Flanker task. The stimuli consist of faces expressing a neutral or angry emotion. The central face (the target) may display the same emotion (congruent condition) or a different emotion (incongruent condition) from the faces on the right and left (two flankers). Participants must say, as quickly and accurately as possible, what the gender of the central face is
Time frame
Day 0Secondary outcomes
1
Psychological profiles: depression
Evaluated through the Hamilton Depression Rating Scale (HAM-D). HAM-D is a widely used self-report scale to assess depressive symptoms consisting of 21 items, which has been validated in French. The total score is obtained by adding the scores of the 17 first items, the score ranging from 0 to 52, with higher scores indicating greater depression symptoms.
Time frame
Day 02
Psychological profiles: mania
Evaluated through the Young Mania Rating Scale (YMRS). The YMRS is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items, the score ranging from 0 to 60 and higher scores indicating greater manic symptoms.
Time frame
Day 03
Psychological profiles: anxiety symptoms
Anxiety severity is assessed with the Spielberger State-Trait Inventory (STAI) which is a 40-item scale, using a 4-point Likert scale for each item. This scale was used to measure both trait anxiety (how dispositionally anxious a person is across time and situations) and state anxiety (how anxious a person is feeling at a particular moment). The total score is obtained by adding items, the score ranging from 20 to 80. Higher scores indicate greater anxiety symptoms.
Time frame
Day 04
Social functioning: quality of life
Evaluated through the World Health Organization Quality of Life (WHOQOL-BREF) quality of life assessment. The WHOQOL-BREF consists of 26 items scored in four domains: physical, psychological, social relationships, and environment. The score ranges from 0 to 100 with the higher score indicating a better quality of life.
Time frame
Day 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
CHU de Reims
Lead sponsor
EPSM de la Marne
Collaborator
Source ClinicalTrials.gov
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