3TOC: Cerebral and Cognitive Markers of Treatment Resistance in Obsessive Compulsive Disorder

Sponsor

Centre Hospitalier Henri Laborit (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05843604

Collaborator

(none)

100

Enrollment

28.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
OCD	Other: Functional MRI

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Cerebral and Cognitive Markers of Treatment Resistance in Obsessive-compulsive Disorder: Towards Personalization of Patient Care

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
obsessive compulsive disorder patients	Other: Functional MRI Three cognitive tests will be performed in the MRI, namely a stroop task, an N-back task and a switching task
Control Patients	Other: Functional MRI Three cognitive tests will be performed in the MRI, namely a stroop task, an N-back task and a switching task

Arm

Intervention/Treatment

obsessive compulsive disorder patients

Other: Functional MRI

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

Control Patients

Other: Functional MRI

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

Outcome Measures

Primary Outcome Measures

Cerebral activity modification during N-back task [Day 1]
Blood-oxygen-level-dependent (BOLD) modification during the task between obsessive compulsive disorder patients and controls
Cerebral activity modification during Stroop task [Day 1]
Blood-oxygen-level-dependent (BOLD) modification during the task between obsessive compulsive disorder patients and controls
Cerebral activity modification during switching task (Monsell et Mizon task ) [Day 1]
Blood-oxygen-level-dependent (BOLD) modification during the task between obsessive compulsive disorder patients and controls

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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)
Generalized anxiety disorder, social anxiety, nicotine dependence and history of a major depressive episode are not exclusion criteria according to 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Henri Laborit

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Henri Laborit

ClinicalTrials.gov Identifier:

NCT05843604

Other Study ID Numbers:

2022-A00463-40

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Henri Laborit

functional MRI

Additional relevant MeSH terms:

Compulsive Personality Disorder

Obsessive-Compulsive Disorder

Study Results

No Results Posted as of May 6, 2023