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

Brain Biomarkers as Response Predictors to Selective Serotonin Reuptake Inhibitors in Obsessive-Compulsive Disorder: development of a paradigm towards personalized medicine

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9hpwgjy
Enrollment
Unknown
Registered
2022-03-15
Start date
2021-01-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder with predominance of obsessive ideas or ruminations

Interventions

A total of 30 patients will receive drug treatment with a serotonin reuptake inhibitor, preferably Sertraline hydrochloride. The drug should be administered orally, during the first week at a dose of
F42.2

Sponsors

Instituto de Psiquiatria
Lead Sponsor
Instituto de Psiquiatria
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil, India, South Africa

Contacts

Public ContactRoseli Shavitt

Instituto de Psiquiatria

protoc.brics@gmail.com+55-11-2661-6972

Outcome results

None listed

Source: REBEC (via WHO ICTRP)