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Original Investigation
January 26, 2022

Maintenance of Wellness in Patients With Obsessive-Compulsive Disorder Who Discontinue Medication After Exposure/Response Prevention Augmentation: A Randomized Clinical Trial

Author Affiliations
  • 1Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia
  • 2Department of Psychiatry, Columbia University, New York, New York
  • 3New York State Psychiatric Institute, New York
  • 4Associate Editor, JAMA Psychiatry
  • 5Barnard College, Columbia University, New York, New York
  • 6The Hebrew University of Jerusalem, Jerusalem, Israel
  • 7University of Wisconsin, Milwaukee
  • 8Center for Anxiety and Behavior Therapy, Bryn Mawr, Pennsylvania
  • 9Department of Psychology, University of Utah, Salt Lake City
  • 10Rutgers University/Biomedical Health Sciences, New Brunswick, New Jersey
  • 11Department of Psychology, West Virginia University, Morgantown
  • 12Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, The Zucker Hillside Hospital, Glen Oaks, New York
  • 13Department of Psychology, Southern Methodist University, Dallas, Texas
JAMA Psychiatry. 2022;79(3):193-200. doi:10.1001/jamapsychiatry.2021.3997
Visual Abstract. Maintenance of Wellness in Patients With Obsessive-Compulsive Disorder After Exposure/Response Therapy
Maintenance of Wellness in Patients With Obsessive-Compulsive Disorder After Exposure/Response Therapy
Key Points

Question  Can patients with obsessive-compulsive disorder (OCD) who take serotonin reuptake inhibitors (SRIs) and attain wellness (defined as Yale-Brown Obsessive-Compulsive Scale score ≤14 points) after augmentation with exposure/response prevention (EX/RP) therapy discontinue their SRIs and maintain wellness?

Findings  In this randomized clinical trial, 101 patients with OCD who received SRIs and achieved wellness after EX/RP therapy were randomly assigned to either taper to placebo or to continuation of SRIs. At 24 weeks, patients who tapered to placebo had noninferior outcomes compared with patients who continued SRIs; however, patients who tapered to placebo had higher rates of clinical worsening.

Meaning  Patients with OCD who achieve wellness after EX/RP therapy may be able to discontinue their SRI with noninferior outcomes compared with those who continue their SRI, but careful monitoring is needed.

Abstract

Importance  Serotonin reuptake inhibitors (SRIs) are the only medications approved for obsessive-compulsive disorder (OCD), yet most patients taking SRIs exhibit significant symptoms. Adding exposure/response prevention (EX/RP) therapy improves symptoms, but it is unknown whether patients maintain wellness after discontinuing SRIs.

Objective  To assess whether patients with OCD who are taking SRIs and have attained wellness after EX/RP augmentation can discontinue their SRI with noninferior outcomes compared with those who continue their SRI therapy.

Design, Setting, and Participants  A 24-week, double-blind, randomized clinical trial was performed from May 3, 2013, to June 25, 2018. The trial took place at US academic medical centers. Participants included 137 adults with a principal diagnosis of OCD (≥1 year) who were taking an SRI (≥12 weeks), had at least moderate symptoms (defined as Yale-Brown Obsessive-Compulsive Scale [Y-BOCS] score ≥18 points), and received as many as 25 sessions of EX/RP therapy. Those who attained wellness (Y-BOCS score ≤14 points; 103 patients [75.2%]) were study eligible. Data were analyzed from June 29, 2019, to October 2, 2021.

Intervention  Participants were randomly assigned either to receive taper to placebo (taper group) or to continue their SRI (continuation group) and monitored for 24 weeks.

Main Outcome and Measures  The Y-BOCS score (range, 0-40 points) was the primary outcome; the Hamilton Depression Rating Scale (HDRS; range, 0-52 points) and the Quality-of-Life Enjoyment and Satisfaction Questionnaire–Short Form (Q-LES-Q-SF; range, 0%-100%) scores were secondary outcomes. Outcomes were assessed at 8 time points by independent evaluators who were blinded to randomization. The taper regimen was hypothesized to be noninferior to continuation at 24 weeks using a 1-sided α value of .05.

Results  A total of 101 patients (mean [SD] age, 31.0 [11.2] years; 55 women [54.5%]) participated in the trial: 51 patients (50.5%) in the taper group and 50 patients (49.5%) in the continuation group. At 24 weeks, patients in the taper group had noninferior results compared with patients in the continuation group (mean [SD] Y-BOCS score: taper group, 11.47 [6.56] points; continuation group: 11.51 [5.97] points; difference, −0.04 points; 1-sided 95% CI, −∞ to 2.09 points [below the noninferiority margin of 3.0 points]; mean [SD] HDRS score: taper group, 5.69 [3.84] points; continuation group, 4.61 [3.46] points; difference, 1.08 points; 1-sided 95% CI, −∞ to 2.28 points [below the noninferiority margin of 2.5 points]; mean [SD] Q-LES-Q-SF score: taper group, 68.01% [15.28%]; continuation group, 70.01% [15.59%]; difference, 2.00%; 1-sided 95% CI, −∞ to 6.83 [below the noninferiority margin of 7.75]). However, the taper group had higher rates of clinical worsening (23 of 51 [45%] vs 12 of 50 [24%]; P = .04).

Conclusions and Relevance  Results of this randomized clinical trial show that patients with OCD who achieve wellness after EX/RP therapy could, on average, discontinue their SRI with noninferior outcomes compared with those who continued their SRI. Those who tapered the SRI had higher clinical worsening rates. Future research should evaluate if SRI half-life alters these rates.

Trial Registration  ClinicalTrials.gov Identifier: NCT01686087

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