NCT01368510

Brief Summary

Even with the best available treatments for obsessive-compulsive disorder (OCD), most patients only partially recover and many patients do not respond at all. Such incomplete and inadequate response contributes to greater public health costs in terms of morbidity and patient care expenses. This study aims for a better understanding of abnormal brain chemistry in OCD and how it is affected by cognitive-behavioral therapy (CBT) in order to develop novel therapies and improve the success of existing therapies. The main hypothesis is that CBT will change levels of the excitatory neurotransmitter glutamate in OCD patients in a region of the brain involved in OCD known as the cingulate cortex.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

3.9 years

First QC Date

June 6, 2011

Last Update Submit

March 23, 2020

Conditions

Keywords

obsessive-compulsive disorder (OCD)cognitive-behavioral therapy (CBT)magnetic resonance spectroscopy (MRS)glutamatecingulate gyrus

Outcome Measures

Primary Outcomes (1)

  • MRSI glutamate

    Regional concentration of glutamate in brain, as measured by magnetic resonance spectroscopic imaging (MRSI)

    4 weeks

Secondary Outcomes (1)

  • Y-BOCS

    4 weeks

Study Arms (3)

OCD Active CBT

EXPERIMENTAL

Adults with obsessive-compulsive disorder (OCD) will be treated with cognitive-behavioral therapy (CBT) from the time of enrollment.

Behavioral: Intensive Cognitive Behavioral Therapy (CBT)

OCD Waitlist

ACTIVE COMPARATOR

Adults with OCD will receive waitlist treatment at enrollment. Nonresponders will cross over to CBT.

Behavioral: Intensive Cognitive Behavioral Therapy (CBT)Behavioral: Waitlist

Healthy Control

NO INTERVENTION

Healthy control adults will be given no intervention.

Interventions

Nondrug psychotherapy administered daily 5 days/week for 4 weeks

Also known as: Exposure and Response Prevention (ERP)
OCD Active CBTOCD Waitlist
WaitlistBEHAVIORAL

Minimal contact waitlist weekly for 4 weeks

OCD Waitlist

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meets DSM-IV-TR diagnostic criteria for OCD as primary (most severe) diagnosis based on Anxiety Disorders Interview Schedule (ADIS) Clinical Severity Rating
  • reported DSM-IV-TR-threshold OCD symptom onset age 18 or later
  • Yale-Brown Obsessive-Compulsive total score greater than or equal to 16
  • fluent English speaker
  • signed informed consent

You may not qualify if:

  • IQ of less than 80 on the Wechsler Abbreviated Scales of Intelligence
  • lifetime DSM-IV diagnosis of pervasive developmental disorder, mania, psychosis, conduct disorder, or substance dependence assessed through ADIS
  • current DSM-IV diagnosis of major depressive disorder if ADIS CSR rating is 4 or higher (severe) or attention-deficit hyperactivity disorder
  • primary compulsive hoarding
  • any changes (dose or agent) in psychotropic medication for OCD or other psychiatric condition within 12 weeks prior to enrollment
  • severe illness that requires immediate inpatient psychiatric intervention
  • any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current study
  • any body metal (other than dental fillings), positive pregnancy test, or other MR scan contraindications
  • prior trial of CBT for OCD, regardless of outcome
  • medical conditions that affect cerebral metabolism (e.g., thyroid disorders or diabetes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Obsessive-Compulsive Disorder Intensive Treatment Program

Los Angeles, California, 90024, United States

Location

Related Publications (2)

  • Reggente N, Moody TD, Morfini F, Sheen C, Rissman J, O'Neill J, Feusner JD. Multivariate resting-state functional connectivity predicts response to cognitive behavioral therapy in obsessive-compulsive disorder. Proc Natl Acad Sci U S A. 2018 Feb 27;115(9):2222-2227. doi: 10.1073/pnas.1716686115. Epub 2018 Feb 12.

  • Moody TD, Morfini F, Cheng G, Sheen C, Tadayonnejad R, Reggente N, O'Neill J, Feusner JD. Mechanisms of cognitive-behavioral therapy for obsessive-compulsive disorder involve robust and extensive increases in brain network connectivity. Transl Psychiatry. 2017 Sep 5;7(9):e1230. doi: 10.1038/tp.2017.192.

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Joseph O'Neill, PhD

    UCLA Child Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Child Psychiatry

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 8, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations