Clinical trial NCT01686087: Attaining and Maintaining Wellness in Obsessive-compulsive Disorder
Official title: Attaining and Maintaining Wellness in OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-09-17
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Obsessive Compulsive Symptom Severity (Y-BOCS)
timeFrame: 6 months
Secondary outcomes:
measure: Depressive severity (HAMD17)
timeFrame: 6 months
measure: Quality of Life (QLESQ-S)
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for the Treatment and Study of Anxiety
state: Pennsylvania
Study officials:
affiliation: NY State Psychiatric Institute at Columbia University
name: Helen B Simpson, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Edna Foa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.