Obsessive Compulsive DisorderNCT01686087
Attaining and Maintaining Wellness in Obsessive-compulsive Disorder
A study testing Monthly Booster Sessions of EX/RP and Visits with MD and independent evaluators in people with Obsessive Compulsive Disorder, run by New York State Psychiatric Institute at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Monthly Booster Sessions of EX/RP and Visits with MD and independent evaluators
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Those who achieve mild to minimum OCD symptoms from Preparatory Phase will enter the Study Phase
Who cannot join
- 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
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York State Psychiatric Institute
New York, New York, 10032
University of Pennsylvania Center for the Treatment and Study of Anxiety
Philadelphia, Pennsylvania, 19104
About this study
Official title: Attaining and Maintaining Wellness in OCD
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.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Monthly Booster Sessions of EX/RP, Visits with MD and independent evaluators
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly Booster Sessions of EX/RPBehavioural
45 minute EXRP booster sessions each month
Visits with MD and independent evaluatorsProcedure or surgery
All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Monthly Booster Sessions of EX/RP; Procedure: Visits with MD and independent evaluators |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
Depressive severity (HAMD17)
Hamilton Depression Scale (HAMD, 17 item)
Measured: 6 months
Quality of Life (QLESQ-S)
Quality of Life Satisfaction Questionnaire (QLESQ, short form)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Helen Blair Simpson, New York State Psychiatric Institute
- Investigators
- Helen B Simpson, MD PhD, Principal investigator, NY State Psychiatric Institute at Columbia UniversityEdna Foa, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686087
- Sponsor's protocol ID
- 6628
- Other IDs
- 2R01MH045436-18
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2012
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
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 39879875Foa 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attaining and Maintaining Wellness in OCD
- ClinicalTrials.gov ID
- NCT01686087
- Acronym / sponsor ID
- 6628
- Conditions
- Obsessive Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2012 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 17 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuation of SRI | Active comparator | Behavioral: Monthly Booster Sessions of EX/RP, Procedure: Visits with MD and independent evaluatorsPatients 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. |
| Replace SRI w/placebo | Placebo comparator | Behavioral: Monthly Booster Sessions of EX/RP, Procedure: Visits with MD and independent evaluatorsPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- Those who achieve mild to minimum OCD symptoms from Preparatory Phase will enter the Study Phase
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monthly Booster Sessions of EX/RP45 minute EXRP booster sessions each month | Behavioural | Continuation of SRI, Replace SRI w/placebo |
| Visits with MD and independent evaluatorsAll patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms. | Procedure or surgery | Continuation of SRI, Replace SRI w/placebo |
Primary outcome
Obsessive Compulsive Symptom Severity (Y-BOCS)
Time frame: 6 months
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
2 secondary outcomes
Depressive severity (HAMD17)
Time frame: 6 months
Quality of Life (QLESQ-S)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 39879875Wheaton 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.
- Derived from this study: PubMed 35080598Foa 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.
Related trials for Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
RecruitingPhase 2
SONATA Dose Duration LIFU for OCD
Obsessive - Compulsive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen B Simpson, MD PhD principal investigator
NY State Psychiatric Institute at Columbia University
Edna Foa, PhD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly Booster Sessions of EX/RP and Visits with MD and independent evaluators in people with Obsessive Compulsive Disorder, run by New York State Psychiatric Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsessive Compulsive Symptom Severity (Y-BOCS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686087, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.