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

作者：Storch Eric A^*; Goddard Andrew W; Grant Jon E; De Nadai Alessandro S; Goodman Wayne K; Mutch P Jane; Medlock Carla; Odlaug Brian; McDougle Christopher J; Murphy Tanya K

来源：Journal of Clinical Psychiatry, 2013, 74(6): E527-E532.

DOI：10.4088/JCP.12m08278

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). %26lt;br%26gt;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. %26lt;br%26gt;Results: Paliperidone administration resulted in significant baseline-to-posttreatment reductions in obsessive-compulsive symptoms as measured by the YBOCS (P%26lt;.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). %26lt;br%26gt;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.

• 出版日期2013-6