title: Cognitive-behavioral therapy vs risperidone for augmenting serotonin reuptake inhibitors in obsessive-compulsive disorder: a randomized clinical trial.
abstract: OBJECTIVE
  Obsessive-compulsive disorder (OCD) is one of the world's most disabling illnesses according to the World Health Organization. Serotonin reuptake inhibitors (SRIs) are the only medications approved by the Food and Drug Administration to treat OCD, but few patients achieve minimal symptoms from an SRI alone. In such cases, practice guidelines recommend adding antipsychotics or cognitive-behavioral therapy consisting of exposure and ritual prevention (EX/RP).
  
  
  OBJECTIVE
  To compare the effects of these 2 SRI augmentation strategies vs pill placebo for the first time, to our knowledge, in adults with OCD.
  
  
  METHODS
  A randomized clinical trial (conducted January 2007-August 2012) at 2 academic outpatient research clinics that specialize in OCD and anxiety disorders. Patients (aged 18-70 years) were eligible if they had OCD of at least moderate severity despite a therapeutic SRI dose for at least 12 weeks prior to entry. Of 163 who were eligible, 100 were randomized (risperidone, n = 40; EX/RP, n = 40; and placebo, n = 20), and 86 completed the trial.
  
  
  METHODS
  While continuing their SRI at the same dose, patients were randomized to the addition of 8 weeks of risperidone (up to 4 mg/d), EX/RP (17 sessions delivered twice weekly), or pill placebo. Independent assessments were conducted every 4 weeks.
  
  
  METHODS
  The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) to measure OCD severity.
  
  
  RESULTS
  Patients randomized to EX/RP had significantly greater reduction in week 8 Y-BOCS scores based on mixed-effects models (vs risperidone: mean [SE], -9.72 [1.38]; P < .001 vs placebo: mean [SE], -10.10 [1.68]; P < .001). Patients receiving risperidone did not significantly differ from those receiving placebo (mean [SE], -0.38 [1.72]; P = .83). More patients receiving EX/RP responded (Y-BOCS score decrease ≥25%: 80% for EX/RP, 23% for risperidone, and 15% for placebo; P < .001). More patients receiving EX/RP achieved minimal symptoms (Y-BOCS score ≤12: 43% for EX/RP, 13% for risperidone, and 5% for placebo; P = .001). Adding EX/RP was also superior to risperidone and placebo in improving insight, functioning, and quality of life.
  
  
  CONCLUSIONS
  Adding EX/RP to SRIs was superior to both risperidone and pill placebo. Patients with OCD receiving SRIs who continue to have clinically significant symptoms should be offered EX/RP before antipsychotics given its superior efficacy and less negative adverse effect profile.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00389493.
authors.affiliation: Department of Psychiatry, Columbia University, New York, New York2New York State Psychiatric Institute, New York, New York.
authors.forename: Helen Blair
authors.initials: HB
authors.lastname: Simpson
authors.forename: Edna B
authors.initials: EB
authors.lastname: Foa
authors.forename: Michael R
authors.initials: MR
authors.lastname: Liebowitz
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Huppert
authors.forename: Shawn
authors.initials: S
authors.lastname: Cahill
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Maher
authors.forename: Carmen P
authors.initials: CP
authors.lastname: McLean
authors.forename: James
authors.initials: J
authors.lastname: Bender
authors.forename: Sue M
authors.initials: SM
authors.lastname: Marcus
authors.forename: Monnica T
authors.initials: MT
authors.lastname: Williams
authors.forename: Jamie
authors.initials: J
authors.lastname: Weaver
authors.forename: Donna
authors.initials: D
authors.lastname: Vermes
authors.forename: Page E
authors.initials: PE
authors.lastname: Van Meter
authors.forename: Carolyn I
authors.initials: CI
authors.lastname: Rodriguez
authors.forename: Mark
authors.initials: M
authors.lastname: Powers
authors.forename: Anthony
authors.initials: A
authors.lastname: Pinto
authors.forename: Patricia
authors.initials: P
authors.lastname: Imms
authors.forename: Chang-Gyu
authors.initials: CG
authors.lastname: Hahn
authors.forename: Raphael
authors.initials: R
authors.lastname: Campeas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy* / Q000628:therapy*; D018967:Risperidone / Q000008:administration & dosage / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D016037:Single-Blind Method
chemical_list: D014150:Antipsychotic Agents; D018967:Risperidone; D017367:Selective Serotonin Reuptake Inhibitors
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