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Predicting Treatment Response in Patients With OCD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03993535
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : May 20, 2022
University of Stellenbosch
Columbia University
National Institute of Mental Health and Neuro Sciences, India
Amsterdam UMC, location VUmc
Information provided by (Responsible Party):
Roseli Gedanke Shavitt, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: selective serotonin reuptake inhibitor Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 12-month naturalistic follow-up of open treatment with evidence-based pharmacologic agents (SSRIs) or cognitive-behavioral therapy (CBT) for OCD
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical, Neurocognitive and Neuroimaging Variables Associated With Response to Treatment in Patients With OCD
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : September 21, 2022
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Arm Intervention/treatment
SSRI or cognitive behavioral therapy
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
open treatment based on patient preference and treatment availability
Other Name: CBT

Primary Outcome Measures :
  1. response status [ Time Frame: 12 months ]
    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).

  2. level of improvement [ Time Frame: 12 months ]
    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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03993535

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Contact: Roseli G Shavitt, MD, PhD +5511999318626
Contact: Daniel LC Costa, MD, PhD +5511972100082

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United States, New York
Center for OCD and Related Disorders, New York State Psychiatric Institute/Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Rachel Middleton, BA    646-774-8138   
Institute of Psychiatry - Hospital of Clinics - University of São Paulo Recruiting
São Paulo, Brazil, 05403-000
Contact: Euripedes C Miguel, MD, PhD    551126617594   
Principal Investigator: Roseli G Shavitt, MD, PhD         
OCD Clinic, Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS) Recruiting
Bangalore, India, 560029
Contact: YC Janardhan Reddy, MD, DPM    +9108026995278   
Contact: Janardhanan Narayanaswamy, MD    +9108026995837   
South Africa
Faculty of Medicine and Health Sciences, Department of Psychiatry, Stellenbosch University Recruiting
Cape Town, South Africa, 7505
Contact: Christine Lochner, PhD    27 21 938 9179   
Contact: Dan Stein, MD, PhD    27 21 938 9165   
Sponsors and Collaborators
University of Sao Paulo
University of Stellenbosch
Columbia University
National Institute of Mental Health and Neuro Sciences, India
Amsterdam UMC, location VUmc
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Principal Investigator: Roseli G Shavitt, MD, PhD University of Sao Paulo

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Responsible Party: Roseli Gedanke Shavitt, Director, Obsessive-Compulsive Spectrum Disorders Program, Institute of Psychiatry, Hospital of Clinics, University of Sao Paulo School of Medicine, University of Sao Paulo Identifier: NCT03993535    
Other Study ID Numbers: 68743617800000068
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Roseli Gedanke Shavitt, University of Sao Paulo:
obsessive-compulsive disorder
Additional relevant MeSH terms:
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Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators