Cerebral and Cognitive Markers of Treatment Resistance in Obsessive Compulsive Disorder

OCD Clinical Trial

— 3TOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843604
• Other study ID #: 2022-A00463-40
• Status: Recruiting
• Start date: July 3, 2023
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Henri Laborit
• Contact: Damien Doolub, MD
• Phone: +33 (0)5 16 61 18
• Email: damien.doolub[@]ch-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• OCD

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Laborit	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cerebral activity modification during Stroop task	Blood-oxygen-level-dependent (BOLD) modification during the task between obsessive compulsive disorder patients and controls	Day 1
Primary	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