Predicting Treatment Response in Patients With OCD

February 26, 2024 updated by: Roseli Gedanke Shavitt, University of Sao Paulo

Clinical, Neurocognitive and Neuroimaging Variables Associated With Response to Treatment 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 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to investigate clinical, neurocognitive and neuroimaging variables associated with response to conventional treatments in adults with OCD.

Study design:

  • 0-52 weeks: open-label trial of a selective serotonin reuptake inhibitor (SSRI) (preferably sertraline - easily available in the public network, usually well tolerated) up to the maximum recommended or tolerated dose (e.g., titration: start with 50mg/day, then add 50mg/day per week up to 200mg/day, if sertraline); patients who prefer to be treated with cognitive-behavioral therapy (CBT) will be given this option whenever CBT is available.
  • treatment will be delivered under naturalistic conditions, tailored according to the needs, preference, and availability. Subjects will be called up for follow-up assessments at 3, 6, 9 and 12 months after baseline assessments. The instruments to be used at follow-up are the YBOCS and CGI scales.
  • Response criteria: the definitions of a recent international expert consensus will be adopted (Mataix-Cols. et al., 2016). A positive response will be considered as at least 35% reduction in baseline Yale-Brown Obsessive-Compulsive Scale (YBOCS) scores plus a Clinical Global Impression-Improvement (CGI-I) rating of 1 ("very much improved") or 2 ("much improved"), lasting for at least one week. We will also rate the CGI - severity. Partial response will correspond to a greater than 25% but less than 35% reduction in Y-BOCS scores plus a CGI-I rating of at least 3 ("minimally improved"), lasting for at least one week.

Subjects:

• All participants assessed for clinical, neurocognitive and neuroimaging data in the global brain signatures study who are willing to receive evidence-based treatment for OCD.

Assessments:

  • Baseline: clinical, neurocognitive and neuroimaging protocols.

    1. Clinical: interviewer-delivered and self-report measures to determine: socio-demographic data, past medical history, psychiatric family history, psychiatric diagnoses, OCD symptom dimensions, the severity of OCD, insight into OCD, sensory phenomena, the severity of depression and anxiety symptoms, severity of compulsive-impulsive behaviors, level of disability
    2. Neurocognitive: executive function, emotional regulation, memory
    3. Neuroimaging: structural MRI, resting-state functional MRI (rs-fMRI), Diffusion Tensor Imaging (DTI)
  • Months 3, 6, 9 and 12: YBOCS checklist and past week severity; CGI - improvement subscale, relative to baseline; CGI - severity subscale; assessments can be in person or by phone, by the same independent evaluator at the different time points
  • 1 year: treatment history form, YBOCS severity and checklist, Impulsive-Compulsive Behaviors Checklist (ICBC), Obsessive-Compulsive Inventory-Revised (OCI-R), Hamilton Depression Scale (HAM-D), Hamilton Anxiety Scale (HAM-A), World Health Organization Disability Assessment Schedule (WHODAS), CGI.

Hypotheses (built from the literature): the following variables (as assessed at baseline) will show an association with response to treatment:

Clinical:

  1. duration of untreated illness (Alarcon et al., 1993; Ravizza et al., 1995; Stein et al., 2001);
  2. comorbidity: presence of comorbid social anxiety disorder (Carrasco et al., 1992), depressive disorders (Jakubovski et al., 2013); Post-Traumatic Stress Disorder (PTSD) (Shavitt et al., 2010);
  3. level of insight (Erzegovesi et al., 2001);
  4. symptom dimension: presence and severity of symmetry, contamination and hoarding dimensions (Alarcon et al., 1993; Ferrão et al., 2006; Mataix-Cols et al., 1999; Hazari et al., 2016)

Neurocognitive: decision making, verbal IQ (D'Alcante et al., 2012), verbal memory/learning (D'Alcante et al., 2012), inhibitory control and mental flexibility tasks (Flessner et al., 2010; Hazari et al., 2016).

Neuroimaging:

I. Structural: brain volumes in the orbitofrontal cortex, anterior cingulate, striatum, dorsolateral and dorsomedial prefrontal cortex (Yun et al., 2015), insula (Yun et al., 2015), thalamus, hippocampus, pituitary gland (Atmaca et al., 2016), amygdala (Szeszko et al., 2004), and cerebellum.

II. Structural connectivity (Diffusion Tensor Imaging - DTI): fractional anisotropy measures in the corpus callosum, the internal capsule, white matter in the area superolateral to the right caudate, bilateral cingulum, superior longitudinal fasciculus, and inferior longitudinal fasciculus (Cannistraro et al., 2007; Szeszko wt al., 2005; Yoo et al., 2007; Garibotto et al., 2010).

III. Functional connectivity (rs-fMRI): patterns of activation and connectivity in frontal-striatal (central executive), parietal, occipital, cerebellar, and insula-limbic (saliency) networks (Shin et al., 2014; Bhikram et al., 2016; Nakao et al., 2005; Sanematsu et al., 2010) IV. Exploratory: multimodal analyses of prediction

Analyses plan: parametric and non-parametric tests will be employed as indicated.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-000
        • Institute of Psychiatry - Hospital of Clinics - University of São Paulo
  • India
      • Bangalore, India, 560029
        • OCD Clinic, Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS)
  • South Africa
      • Cape Town, South Africa, 7505
        • Faculty of Medicine and Health Sciences, Department of Psychiatry, Stellenbosch University
  • United States
    • New York
      • New York, New York, United States, 10032
        • Center for OCD and Related Disorders, New York State Psychiatric Institute/Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months
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)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Columbia University
Amsterdam UMC, location VUmc
University of Stellenbosch
National Institute of Mental Health and Neuro Sciences, India

Investigators

  • Principal Investigator: Roseli G Shavitt, MD, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (Actual)

June 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68743617800000068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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