NCT07503275

Brief Summary

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:

  • 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 Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
43mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

March 11, 2026

Last Update Submit

March 25, 2026

Conditions

Bipolar DisorderMajor Depressive Disorder

Keywords

fMRIbipolar disordermajor depressive disorderinhibitory control

Outcome Measures

Primary Outcomes (2)

  • 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%).

    Day 0

  • 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

    Day 0

Secondary Outcomes (5)

  • Psychological profiles: depression

    Day 0

  • Psychological profiles: mania

    Day 0

  • Psychological profiles: anxiety symptoms

    Day 0

  • Social functioning: quality of life

    Day 0

  • Executive functions: verbal inhibition performance

    Day 0

Study Arms (4)

Group 1: Bipolar patients

EXPERIMENTAL

Patients with a diagnosis of bipolar disorder

Behavioral: Analysis of inhibitory control

Group 2: Major depressive patients

EXPERIMENTAL

Patients with a diagnosis of major depressive disorder

Behavioral: Analysis of inhibitory control

Group 3: Bipolar controls

ACTIVE COMPARATOR

Healthy control participants matched to group 1

Behavioral: Analysis of inhibitory control

Group 4: Depressive controls

ACTIVE COMPARATOR

Healthy control participants matched to group 2

Behavioral: Analysis of inhibitory control

Interventions

Analysis of inhibitory controlBEHAVIORAL

Investigation of neurofunctional characterization of inhibitory control using a comprehensive clinical, cognitive assessment and task-based MRI exams

Group 1: Bipolar patientsGroup 2: Major depressive patientsGroup 3: Bipolar controlsGroup 4: Depressive controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Patients enrolled in the national healthcare insurance program
  • Consenting to participate to the study

You may not qualify if:

  • 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)
  • Group 3 and 4: Healthy control participants
  • Participants between 18 and 65 years old, men or women, right-handed
  • Being a native French speaker
  • Patients enrolled in the national healthcare insurance program
  • Consenting to participate to the study
  • A diagnosis of schizophrenia or of bipolar disorder or of major depressive disorder according to DSM-5 criteria
  • The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence
  • Participants having one first-degree relative presenting an bipolar disorder or depressive disorder or schizophrenia according to DSM-5 criteria
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Bipolar DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersDepressive Disorder

Central Study Contacts

Martina TRAYKOVA

CONTACT

0326402254traykovam@epsm-marne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: participants are assigned to one of two or more groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 31, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)