COLIBRINCT07503275

Functional Magnetic Resonance Imaging Study of Inhibitory Control in Bipolar Disorder and Major Depressive Disorder

StatusRecruiting

PhaseNot applicable

SponsorCHU de Reims

Primary completionNov 2029 (estimated)

At risk: Primary completion moved at least 32 days later.

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 12, 2026 Recruitment opened Show 7 more changesShow less
- Start date changed from estimate of Jun 2026 to Nov 3, 2026
- Eligibility criteria expanded, about 20 words
- Primary completion pushed from Sep 2029 to Nov 2029
- Study completion date: Dec 2029 to Jan 2030
- Secondary endpoints: details revised at 5 of 5 entries
- Study description expanded, about 13 words
- Site details revised
Mar 25, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

fMRI activations during an behavioral inhibition task (emotional stop signal task)

Timeframe: Day 0

fMRI activations during an emotional interference control (emotional Flanker task)

Timeframe: Day 0

Secondary (5)

Psychological profiles: depression

Psychological profiles: mania

Psychological profiles: anxiety symptoms

Social functioning: quality of life

Executive functions: verbal inhibition performance

Arms and interventions

Group 1: Bipolar patientsExperimental

Patients with a diagnosis of bipolar disorder

Group 2: Major depressive patientsExperimental

Patients with a diagnosis of major depressive disorder

Group 3: Bipolar controlsActive comparator

Healthy control participants matched to group 1

Group 4: Depressive controlsActive comparator

Healthy control participants matched to group 2

Behavioral: Analysis of inhibitory control

Sites

1 site in 1 country

Chu ReimsReims, Reims, France

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.

Trial details

Enrollment: 120 participants (estimated)
Started: Nov 3, 2026
Study completion: Jan 2030 (estimated)
Eligibility: 18 to 65, all sexes, healthy volunteers accepted
Design: Interventional, non-randomized, open label, basic science
Oversight: No data monitoring committee
Conditions: Bipolar Disorder, Major Depressive Disorder
Collaborators: Public Mental Health Institution of the Marne
Official title: Neurofunctional Characterization of Inhibitory Control in Bipolar Disorder and Major Depressive Disorder
First posted: Mar 31, 2026
Registry updated: Nov 13, 2026
Last verified: Nov 2026

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