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NCT03993535 · ClinicalTrials.gov registry record · Phase 4
Predicting Treatment Response in Patients With OCD
A Phase 4 study of Obsessive - Compulsive Disorder, sponsored by University of Sao Paulo.
- Completed
- Registry status
- Phase 4
- Development phase
- 250
- Enrollment target
- 4
- Study locations
NCT03993535: Completed Phase 4 study of Obsessive - Compulsive Disorder, sponsored by University of Sao Paulo.
NCT03993535 is a Phase 4 study of Obsessive - Compulsive Disorder that has completed, run by University of Sao Paulo. The registered enrollment target is 250 participants, below the 2,062-participant average among 84 other Obsessive - Compulsive Disorder trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03993535, a Phase 4 study of Obsessive - Compulsive Disorder, has completed, sponsored by University of Sao Paulo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 250 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
severity of OCD as measured by the Yale-Brown Obsessive-Compulsive Scale. The final score of this scale is a sum of 10 items, ranging from 0 to 40. The higher the score, the more severe the clinical picture. The ten items refer to ten questions, five regarding obsessions and five regarding compulsions. The questions assess time, distress, interference, resistance and control over the symptoms. Each question can be rated from 0 (= none) to 4 (most severe).
Conditions Studied
Interventions
- DRUG selective serotonin reuptake inhibitor
Study Locations (4)
Other
- Institute of Psychiatry - Hospital of Clinics - University of São Paulo - São Paulo
- OCD Clinic, Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS) - Bangalore
- Faculty of Medicine and Health Sciences, Department of Psychiatry, Stellenbosch University - Cape Town
New York
- Center for OCD and Related Disorders, New York State Psychiatric Institute/Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2018-10-10 |
| Est. Completion | 2023-04-30 |
| Phase | Phase 4 |
What the finished NCT03993535 record still lists
NCT03993535 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 2,062-participant average among 84 other Obsessive - Compulsive Disorder trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Obsessive - Compulsive Disorder appearing as the primary indexed condition, and to 1 intervention - of which selective serotonin reuptake inhibitor is the first listed.
NCT03993535 reports a single indexed study location in Other, New York.
Frequently Asked Questions
What is clinical trial NCT03993535 about?
NCT03993535 is a clinical study titled "Predicting Treatment Response in Patients With OCD". 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...
What is the current status of trial NCT03993535?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 250 participants. The study started on 2018-10-10. Estimated completion is 2023-04-30.
What conditions does trial NCT03993535 study?
This clinical trial studies the following conditions: Obsessive - Compulsive Disorder.
What interventions are being tested in trial NCT03993535?
The interventions under investigation include: selective serotonin reuptake inhibitor (DRUG).
Who is sponsoring clinical trial NCT03993535?
This trial is sponsored by University of Sao Paulo, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03993535 being conducted?
This trial has 4 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obsessive - Compulsive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03993535's enrollment target sits among peer trials
250 12th of 84 higher than 71 of 84 other Obsessive - Compulsive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obsessive - Compulsive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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