Study on the effects of antidepressants on the brain of patients with obsessive-compulsive disorder: research towards personalized medicine

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder with predominance of obsessive ideas or ruminations; Obsessive-Compulsive Disorder with predominance of compulsive behaviors; Obsessive-Compulsive Disorder Mixed form, with obsessive ideas and compulsive behaviors

• Registration Number: RBR-9hpwgjy
• Lead Sponsor: Instituto de Psiquiatria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-15
• Last Update Posted: 29 May 2023
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Male or female aged between 18 and 50 years; Main diagnosis of Obsessive-Compulsive Disorder according to DSM-5; Y-BOCS score = 16; No psychotropic medication used in the last 6 weeks; No behavioral therapy or response prevention exposure focusing on Obsessive-Compulsive Disorder in the past 6 weeks; Able to tolerate a 1-week treatment-free period; and Able to provide informed consent.

Exclusion Criteria

Lifetime diagnosis of psychotic disorder, bipolar disorder, anorexia nervosa, autistic spectrum disorder with IQ<80, Tourette's disorder; Current chronic tic disorder (current = within the last 12 months); Disorders related to the use of current substances, including nicotine (current = within the last 12 months); Current eating disorder or bulimia (current = within the last 12 months); Acute risk of suicide. Pregnant women; Medical or neurological problems (including head trauma with loss of consciousness); Presence of metal devices on the body or dental appliances; IQ<80; Cigarette use: more than 5 per day; Alcohol use: more than 2 drinks a day for women
and more than 3 drinks a day for men; Cannabis use: more than once a week.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find variation in brain volumes in the orbitofrontal cortex, anterior cingulate, striatum, dorsolateral and dorsomedial prefrontal cortex, insula, thalamus, hippocampus, pituitary gland, amygdala and cerebellum, obtained by means of structural NMR, among individuals responders on sertraline for 12 weeks compared with non-responders.

Secondary Outcome Measures

Name	Time	Method
It is expected to find variation in structural connectivity, represented by measurements of fractional anisotropy in the corpus callosum, internal capsule, white matter in the area superolateral to the right caudate, bilateral cingulate, superior longitudinal fasciculus and inferior longitudinal fasciculus, obtained by means of DTI (Diffusion tensor imaging) among responders to sertraline treatment for 12 weeks compared with non-responders;It is expected to find variation in functional connectivity, represented by activation and connectivity patterns in frontal-striatal (central executive), parietal, occipital, cerebellar and insula-limbic (salient) networks, obtained through functional NMR at rest, among responders to sertraline treatment for 12 weeks compared with non-responders.