NCT05843604

Brief Summary

This study aims to define individual profiles of treatment resistants in order to find indicators and predictors of the therapeutic response.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jul 2023Sep 2027

First Submitted

Initial submission to the registry

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 3, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

April 25, 2023

Last Update Submit

January 12, 2026

Conditions

Keywords

functional MRI

Outcome Measures

Primary Outcomes (3)

  • Cerebral activity modification during N-back task

    Blood-oxygen-level-dependent (BOLD) modification during the task between obsessive compulsive disorder patients and controls

    Day 1

  • Cerebral activity modification during Stroop task

    Blood-oxygen-level-dependent (BOLD) modification during the task between obsessive compulsive disorder patients and controls

    Day 1

  • Cerebral activity modification during switching task (Monsell et Mizon task )

    Blood-oxygen-level-dependent (BOLD) modification during the task between obsessive compulsive disorder patients and controls

    Day 1

Study Arms (2)

obsessive compulsive disorder patients

Other: Functional MRI

Control Patients

Other: Functional MRI

Interventions

Three cognitive tests will be performed in the MRI, namely a stroop task, an N-back task and a switching task

Control Patientsobsessive compulsive disorder patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be recruited from the Clinical Research Unit of Poitiers. All volunteer patients included in this study will be included regardless of the degree of resistance to treatment or the severity of their disease. Patients will not be hospitalized for the duration of the study unless their condition requires it. Healthy volunteers will be recruited locally by advertisement or through acquaintances, and will be matched to each patient based on age, gender, laterality, and education level. They must not have an acute pathology being treated, nor take psychotropic drugs, nor be followed in psychotherapy. In their history, we must not find hospitalization in a psychiatric environment or a psychiatric illness according to the M.I.N.I. version 5.0.0.

You may qualify if:

  • Obsessive compulsive disorder diagnosed according to Diagnostic and Statistical Manual 5 criteria (patients will be included regardless of the severity and resistance of their pathology and their levels of executive functions)
  • Understand and accept the constraints of the study
  • Be a beneficiary or affiliated to a Health Insurance scheme

You may not qualify if:

  • Present one of the diagnoses according to the criteria of the DSM 5: schizophrenic disorders, substance abuse or dependence to a substance according to the criteria of the M.I.N.I. version 5.0 (Sheehan et al., 1998)
  • Have a serious intercurrent pathology
  • Being a pregnant woman
  • Being a woman of childbearing age without effective contraception.
  • Being hospitalized under duress or on an outpatient basis in a care program
  • Being under judicial protection (reinforced curatorship, guardianship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Henri Laborit

Poitiers, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

July 3, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations