Predicting Treatment Response in Patients With OCD

NCT03993535 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 68743617800000068
• Study Type: interventional
• Target: 250
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorder; predictors; neuroimaging

Outcome Measures

Primary Outcomes (2)

• response status

  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).

  12 months

• level of improvement

  measured by the Clinical Global Impression Scale - severity and improvement subscales. The severity subscale can be rated from 1 to 7, a higher score corresponding to more severe symptoms. The improvement subscale can also be rated from 1 to 7, a greater score corresponding to lesser improvement. Scores are given individually to each subscale, in absolute numbers (1 to 7)

  12 months

Study Arms (1)

SSRI or cognitive behavioral therapy

OTHER

selective serotonin reuptake inhibitors (fluoxetine, sertraline, citalopram, escitalopram, paroxetine or fluvoxamine) or cognitive-behavioral therapy, depending on availability and patient preference

Drug: selective serotonin reuptake inhibitor

Interventions

selective serotonin reuptake inhibitor DRUG

open treatment based on patient preference and treatment availability

Also known as: CBT

SSRI or cognitive behavioral therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Principal DSM-5 diagnosis of OCD
• Y-BOCS ≥ 16
• No psychotropic meds for the last 6 weeks, with the exception of PRN sleeping meds (e.g., zolpidem or trazodone up to 50 mg) and benzos, as long as not within the past week or during study participation
• No CBT/EXRP focused on OCD within the past 6 weeks
• Capable of providing informed consent

You may not qualify if:

• Lifetime diagnosis of psychotic disorder, bipolar disorder, anorexia nervosa, autism spectrum disorder with IQ \< 80, Tourette Disorder
• Current chronic tic disorder (current = in the past 12 months)
• Current substance-related and addictive disorders, including nicotine (current = in the past 12 months)
• Current binge-eating disorder or bulimia (current = in the past 12 months)
• Acute risk of suicide
• Female who is pregnant
• Major medical or neurological problems (including head injury with loss of consciousness) Presence of metallic devices or dental braces
• IQ \< 80
• Cigarette use: more than 5 per day
• Alcohol use: more than 2 drinks per day for women and more than 3 drinks per day for men, Marijuana use: more than once per week

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Stellenbosch: collaborator
• Columbia University: collaborator
• National Institute of Mental Health and Neuro Sciences, India: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (4)

Center for OCD and Related Disorders, New York State Psychiatric Institute/Columbia University Medical Center

New York, New York, 10032, United States

Location

Institute of Psychiatry - Hospital of Clinics - University of São Paulo

São Paulo, 05403-000, Brazil

Location

OCD Clinic, Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS)

Bangalore, 560029, India

Location

Faculty of Medicine and Health Sciences, Department of Psychiatry, Stellenbosch University

Cape Town, 7505, South Africa

Location

Related Publications (25)

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MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Officials

• Roseli G Shavitt, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Obsessive-Compulsive Spectrum Disorders Program, Institute of Psychiatry, Hospital of Clinics, University of Sao Paulo School of Medicine

Model Details: 12-month naturalistic follow-up of open treatment with evidence-based pharmacologic agents (SSRIs) or cognitive-behavioral therapy (CBT) for OCD

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 20, 2019
• Study Start: October 10, 2018
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); BR (1); ZA (1); US (1)