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CompletedNCT01686087Updated Oct 16, 2026

Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

An interventional study of Monthly Booster Sessions of EX/RP and Visits with MD and independent evaluators in Obsessive Compulsive Disorder, sponsored by New York State Psychiatric Institute. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
137
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The goal of this study is to understand whether patients with obsessive-compulsive disorder (OCD) already on serotonin reuptake inhibitors (SRIs) who then 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.

Read the detailed description

This study begins with a Preparatory Phase, wherein all eligible participants (who enter already receiving a SRI) then receive as part of the study up to 25 sessions of Exposure and Ritual Prevention (EX/RP) therapy. At the end of the Preparatory Phase, those who have achieved wellness (mild to minimal symptoms) enter the Study Phase. Those who do not achieve wellness will not continue in the study and are referred for treatment elsewhere. Those who enter the Study Phase continue to receive monthly sessions of EX/RP and are assigned by chance to either continue on their SRI medication or discontinue the SRI gradually over 4-6 weeks as it is replaced with a placebo (sugar pill). The study will compare outcomes six months, including taking blood samples for genetic testing to see whether there are genes that can predict who will or will not benefit from EX/RP. The study tests the effects of adding EX/RP to attaining and maintaining wellness.

02

Conditions studied

  • Obsessive Compulsive Disorder
03

In context

Obsessive-Compulsive Disorder

626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.

This study's enrollment of 137 is above the median of 45 across 510 interventional studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 433 studies on the registry; 25 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Browse New York State Psychiatric Institute studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Preparatory Phase

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • Those who achieve mild to minimum OCD symptoms from Preparatory Phase will enter the Study Phase

Exclusion Criteria:

  • All exclusions listed above for Preparatory Phase are exclusions for Study Phase as well
  • Patients who are depressed at the end of the Preparatory phase are excluded from Study Phase
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
137 participants (actual)

Study arms

  • Active comparator
    Continuation of SRI

    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

  • Placebo comparator
    Replace SRI w/placebo

    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

  • BehavioralMonthly Booster Sessions of EX/RP

    45 minute EXRP booster sessions each month

  • ProcedureVisits with MD and independent evaluators

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

06

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

  1. Depressive severity (HAMD17)

    Hamilton Depression Scale (HAMD, 17 item)

    Time frame: 6 months

  2. Quality of Life (QLESQ-S)

    Quality of Life Satisfaction Questionnaire (QLESQ, short form)

    Time frame: 6 months

07

Study locations

2 sites
  • New York State Psychiatric Institute
    New York, New York 10032, United States
  • University of Pennsylvania Center for the Treatment and Study of Anxiety
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Publications

  • 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. PubMed 39879875 ↗
  • 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. PubMed 35080598 ↗
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2012 to primary completion in Jun 2018, 68 months.

Of 230 non-industry interventional studies with no phase under Obsessive-Compulsive Disorder, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 68. This study's 68 months is above that.

Counting every sponsor, half of 232 studies reached it within 43 months; a quarter within 22 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2012
First posted
Sep 17, 2012
StartActual
Oct 2012
Primary completionActual
Jun 2018
CompletionActual
Jul 2018
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and description
1 update, last Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Minor edits only
    + 2 other changes: verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT01686087
Lead sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Helen Blair Simpson (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, New York State Psychiatric Institute) — Principal investigator
First posted
Sep 17, 2012
Start date
Oct 2012
Primary completion
Jun 2018
Completion
Jul 2018
Last update
Oct 16, 2026

Study contacts

Helen B Simpson, MD PhD
principal investigator · NY State Psychiatric Institute at Columbia University
Edna Foa, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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