Back to results

Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

Primary Purpose

Obsessive Compulsive Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Monthly Booster Sessions of EX/RP

Visits with MD and independent evaluators

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

New York State Psychiatric Institute
University of Pennsylvania Center for the Treatment and Study of Anxiety

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Continuation of SRI

Replace SRI w/placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Depressive severity (HAMD17)

Hamilton Depression Scale (HAMD, 17 item)

Quality of Life (QLESQ-S)

Quality of Life Satisfaction Questionnaire (QLESQ, short form)

Full Information

NCT ID

NCT01686087

First Posted

September 12, 2012

Last Updated

March 12, 2019

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01686087

Brief Title

Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

Official Title

Attaining and Maintaining Wellness in OCD

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

October 2012 (Actual)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study begins with a Preparatory Phase, wherein all eligible participants receive 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 are then assigned by chance to one of two groups. One group will continue on the SRI medication and the other group will discontinue the SRI gradually over 4-6 weeks as it is replaced with a placebo (sugar pill). Neither patients nor study staff will know which group a participant is in. Both groups will continue to receive monthly sessions of EX/RP. The study will examine who has the best response to treatment in this study, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive Compulsive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

137 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuation of SRI

Arm Type

Active Comparator

Arm Description

Arm Title

Replace SRI w/placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Monthly Booster Sessions of EX/RP

Intervention Description

45 minute EXRP booster sessions each month

Intervention Type

Procedure

Intervention Name(s)

Visits with MD and independent evaluators

Intervention Description

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

Primary Outcome Measure Information:

Title

Obsessive Compulsive Symptom Severity (Y-BOCS)

Description

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 Outcome Measure Information:

Title

Depressive severity (HAMD17)

Description

Hamilton Depression Scale (HAMD, 17 item)

Time Frame

6 months

Title

Quality of Life (QLESQ-S)

Description

Quality of Life Satisfaction Questionnaire (QLESQ, short form)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helen B Simpson, MD PhD

Organizational Affiliation

NY State Psychiatric Institute at Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Edna Foa, PhD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York State Psychiatric Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

University of Pennsylvania Center for the Treatment and Study of Anxiety

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35080598

Citation

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.

Results Reference

derived

Learn more about this trial

Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

We'll reach out to this number within 24 hrs