Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

NCT01686087 | Completed DMC

• 2 other identifiers: 66282R01MH045436-18
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to understand whether patients with obsessive-compulsive disorder (OCD) on serotonin reuptake inhibitors (SRIs) who receive a type of Cognitive-behavioral therapy called Exposure and Ritual Prevention (EX/RP) can discontinue their medication if they first do well with EX/RP.

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Obsessive Compulsive Symptom Severity (Y-BOCS)

  In study phase, to determine whether those who have achieved wellness with Cognitive Behavioral Therapy who are on medication can maintain wellness when medication is stopped

  6 months

Secondary Outcomes (2)

• Depressive severity (HAMD17)

  6 months

• Quality of Life (QLESQ-S)

  6 months

Study Arms (2)

Continuation of SRI

ACTIVE COMPARATOR

Patients who achieve minimal to mild OCD symptoms and are not currently depressed at end of preparatory phase will be randomized to stay on SRI. They will receive 45 minute EX/RP booster sessions once per month.

Behavioral: Monthly Booster Sessions of EX/RP; Procedure: Visits with MD and independent evaluators

Replace SRI w/placebo

PLACEBO COMPARATOR

Patients who achieve minimal to mild OCD symptoms and are not currently depressed at end of preparatory phase will be randomized to gradual replacement with pill placebo. They will receive 45 minute EX/RP booster sessions once per month.

Behavioral: Monthly Booster Sessions of EX/RP; Procedure: Visits with MD and independent evaluators

Interventions

Monthly Booster Sessions of EX/RP BEHAVIORAL

45 minute EXRP booster sessions each month

Continuation of SRI; Replace SRI w/placebo

Visits with MD and independent evaluators PROCEDURE

All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.

Continuation of SRI; Replace SRI w/placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of OCD
• Currently on a stable and adequate dose of a serotonin reuptake inhibitor (i.e., clomipramine, fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram) but still have clinically significant OCD symptoms

You may not qualify if:

• Comorbid Psychiatric conditions that significantly elevate the risks of study participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or other cognitive disorder, suicidality)
• Unstable medical conditions that need attention and would make participation in the study unsafe (e.g., very high blood pressure)
• Patients who have already had prior adjunctive EX/RP (more than 8 sessions within 2 months) while receiving an adequate SRI trial
• Patients taking other medications besides an SRI (e.g. antipsychotics, mood stabilizers, other antidepressants besides SRIs)
• Patients who are pregnant, sexually active and not using contraception, or nursing
• Study Phase
• Those who achieve mild to minimum OCD symptoms from Preparatory Phase will enter the Study Phase
• Patients who are depressed at the end of the Preparatory phase are excluded from Study Phase

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

University of Pennsylvania Center for the Treatment and Study of Anxiety

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Wheaton MG, Kalanthroff E, Mandel M, Marsh R, Simpson HB. Neurocognitive performance in obsessive-compulsive disorder before and after treatment with cognitive behavioral therapy. J Behav Ther Exp Psychiatry. 2025 Jun;87:102019. doi: 10.1016/j.jbtep.2025.102019. Epub 2025 Jan 20.

  PMID: 39879875 DERIVED

• Foa EB, Simpson HB, Gallagher T, Wheaton MG, Gershkovich M, Schmidt AB, Huppert JD, Imms P, Campeas RB, Cahill S, DiChiara C, Tsao SD, Puliafico A, Chazin D, Asnaani A, Moore K, Tyler J, Steinman SA, Sanches-LaCay A, Capaldi S, Snorrason I, Turk-Karan E, Vermes D, Kalanthroff E, Pinto A, Hamlett GE, Middleton R, Hahn CG, Xu B, Van Meter PE, Katechis M, Rosenfield D. Maintenance of Wellness in Patients With Obsessive-Compulsive Disorder Who Discontinue Medication After Exposure/Response Prevention Augmentation: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Mar 1;79(3):193-200. doi: 10.1001/jamapsychiatry.2021.3997.

  PMID: 35080598 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Helen B Simpson, MD PhD

  NY State Psychiatric Institute at Columbia University

  PRINCIPAL INVESTIGATOR

• Edna Foa, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry, College of Physicians and Surgeons, Columbia University Director of the Anxiety Disorders Clinic and OCD Research Program, New York State Psychiatric Institute

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 17, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

US (2)