This work may not be copied, distributed, displayed, published, reproduced, transmitted, modified, posted, sold, licensed, or used for commercial purposes. By downloading this file, you are agreeing to the publisher’s Terms & Conditions.

Original Research

Double-Blind, Placebo-Controlled, Pilot Trial of Paliperidone Augmentation in Serotonin Reuptake Inhibitor-Resistant Obsessive-Compulsive Disorder

Eric A. Storch, PhD; Andrew W. Goddard, MD; Jon E. Grant, MD; Alessandro S. De Nadai, MA; Wayne K. Goodman, MD; P. Jane Mutch, PhD; Carla Medlock, RN; Brian Odlaug, MPH; Christopher J. McDougle, MD; and Tanya K. Murphy, MD

Published: June 15, 2013

Article Abstract

Objective: This pilot study explored the efficacy and tolerability of paliperidone augmentation of serotonin reuptake inhibitors (SRIs) in adults with treatment-resistant obsessive-compulsive disorder (OCD).

Method: Thirty-four patients aged 24-67 years (mean = 43.7 years, SD = 11.4) who met DSM-IV criteria for OCD and remained symptomatic following 2 or more past adequate SRI trials (including their current medication) were enrolled from May 2008 to March 2012. Participants were treated for 8 weeks in a double-blind study with either paliperidone (up to 9 mg/d) or matching placebo in addition to their SRI. Blinded raters conducted outcome assessments. The primary outcome, obsessive-compulsive symptom severity, was assessed using the Yale-Brown Obsessive Compulsive Scale (YBOCS). Secondary outcomes included the Clinical Global Impressions-Severity of Illness and -Improvement scales.

Results: Paliperidone administration resulted in significant baseline-to-posttreatment reductions in obsessive-compulsive symptoms as measured by the YBOCS (P < .01, d = 0.66), although placebo administration also resulted in medium-sized, trend-level significant YBOCS changes (P = .05, d = 0.53). In exploratory analyses examining between-group differences, tests for paliperidone superiority relative to placebo were not significant (P = .14, d = 0.34); however, a numerical trend toward significant between-group differences was found, with a reduction of 7.98 points on the YBOCS for the paliperidone group compared to a reduction of 4.02 points for the placebo group. Paliperidone was generally well tolerated and not associated with significant weight gain (mean [SD] weight: paliperidone, pretreatment 84.70 [27.08] kg, posttreatment 84.84 [18.99] kg; vs placebo, pretreatment 77.50 [25.33] kg, posttreatment 77.43 [19.90] kg; P = .21).

Conclusions: These results suggest that paliperidone augmentation is well tolerated and has potential efficacy in the short-term treatment of some patients with SRI-resistant OCD. Well-powered, randomized, controlled studies are necessary to more definitively address the efficacy of this treatment strategy.

Trial Registration: ClinicalTrials.gov identifier: NCT00632229

J Clin Psychiatry 2013;74(6):e527-e532

Submitted: November 10, 2012; accepted February 11, 2013 (doi:10.4088/JCP.12m08278).

Corresponding author: Eric A. Storch, PhD, Department of Pediatrics, Rothman Center for Neuropsychiatry, University of South Florida, Box 7523, 880 6th St South, St Petersburg, FL 33701 (estorch@health.usf.edu).

Volume: 74

Quick Links: Obsessive-Compulsive and Related Disorders

Continue Reading…

Subscribe to read the entire article

$40.00

Buy this Article as a PDF

Sign-up to stay
up-to-date today!

SUBSCRIBE

Already registered? Sign In

Original Research

Telehealth of Coordinated Specialty Care in Early Psychosis During COVID-19

As the COVID-19 pandemic emerged in 2020, access to in-person clinical care was restricted. This study explored...

Read More...