CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 250 enrolled
Drug / intervention
selective serotonin reuptake inhibitordrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03993535
NCT03993535Phase 4Completed

Clinical, Neurocognitive and Neuroimaging Variables Associated With Response to Treatment in Patients With OCD

University of Sao Paulo·interventional·Posted Jun 20, 2019·Updated Feb 28, 2024

In Brief

A Phase 4 clinical trial evaluating selective serotonin reuptake inhibitor for Obsessive-Compulsive Disorder. Completed, enrolled 250 participants across 4 sites in 4 countries.

Detailed Summary

This study consists of a naturalistic follow-up of subjects with Obsessive-Compulsive Disorder (OCD) that have participated in a global study investigating brain signatures of OCD funded by the National Institutes of Mental Health (RO1MH113250), with the following participant sites: the US (Columbia University, PI: Helen Blair Simpson), Brazil (University of Sao Paulo, PIs: Euripedes Miguel and Roseli G Shavitt), India (National Institutes of Mental Health, PI: Janardhan Reddy), The Netherlands (VU Amsterdam Medical Center, PI: Odile van den Heuvel), and South Africa (University of Cape Town, PI: Dan Stein; Stellenbosch University, PI: Christine Lochner). In this cross-sectional study, two-hundred and fifty unmedicated subjects with OCD (50 per site) will be assessed for clinical, neurocognitive and neuroimaging data. After completion of this study, participants willing to receive evidence-based treatments for OCD will be treated with the available resources in each site and will be assessed for treatment response status periodically, with a final assessment after 1 year of naturalistic follow-up. At this point, we will investigate baseline clinical, neurocognitive and neuroimaging variables associated with the treatment response status.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, India, South Africa, United States

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJun 20, 2019
Enrollment StartOct 10, 2018
Primary CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 7.0 years ago

Interventions

selective serotonin reuptake inhibitordrug

open treatment based on patient preference and treatment availability