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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: OCD
• Intervention / Treatment: Other: Functional MRI

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Damien Doolub, MD; Phone Number: +33 (0)5 16 61 18; Email: [email protected]

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Laborit

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: functional MRI
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2022-A00463-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No