Six-month outcomes from a randomized trial augmenting serotonin reuptake inhibitors with exposure and response prevention or risperidone in adults with obsessive-compulsive disorder.
OBJECTIVE
To compare outcomes after 6-month maintenance treatment of adults diagnosed with obsessive-compulsive disorder (OCD) based on DSM-IV criteria who responded to acute treatment with serotonin reuptake inhibitors (SRIs) augmented by exposure and response prevention (EX/RP) or risperidone.


METHODS
A randomized trial was conducted at 2 academic sites from January 2007 through December 2012. In the acute phase, 100 patients on therapeutic SRI dose with at least moderate OCD severity were randomized to 8 weeks of EX/RP, risperidone, or pill placebo. Responders entered the 6-month maintenance phase, continuing the augmentation strategy they received acutely (n = 30 EX/RP, n = 8 risperidone). Independent evaluations were conducted every month. The main outcome was the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).


RESULTS
Intent-to-treat analyses indicated that, after 6-month maintenance treatment, EX/RP yielded OCD outcomes that were superior to risperidone (Y-BOCS = 10.95 vs 18.70; t40 = 2.76, P = .009); more patients randomized to EX/RP met response criteria (Y-BOCS decrease ≥ 25%: 70% vs 20%; P < .001) and achieved minimal symptoms (Y-BOCS ≤ 12: 50% vs 5%; P < .001). During maintenance, OCD severity decreased slightly in both conditions (Y-BOCS decrease = 2.2 points, P = .020). Lower Y-BOCS at entry to maintenance was associated with more improvement in both conditions (r38 = 0.57, P < .001).


CONCLUSIONS
OCD patients taking SRIs who responded to acute EX/RP or risperidone maintained their gains over 6-month maintenance. Because EX/RP patients improved more during acute treatment than risperidone-treated patients, and both maintained their gains during maintenance, EX/RP yielded superior outcomes 6 months later. The findings that 50% of patients randomized to EX/RP had minimal symptoms at 6-month maintenance, a rate double that of prior studies, suggests that EX/RP maintenance helps maximize long-term outcome.


BACKGROUND
ClinicalTrials.gov identifier: NCT00389493.
University of Pennsylvania, School of Medicine, Department of Psychiatry, 3535 Market St, 6th Floor, Philadelphia, PA 19104 foa@mail.med.upenn.edu.
Edna B
EB
Foa
Helen Blair
HB
Simpson
David
D
Rosenfield
Michael R
MR
Liebowitz
Shawn P
SP
Cahill
Jonathan D
JD
Huppert
James
J
Bender
Carmen P
CP
McLean
Michael J
MJ
Maher
Raphael
R
Campeas
Chang-Gyu
CG
Hahn
Patricia
P
Imms
Anthony
A
Pinto
Mark B
MB
Powers
Carolyn I
CI
Rodriguez
Page E
PE
Van Meter
Donna
D
Vermes
Monnica T
MT
Williams
D000293:Adolescent; D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007171:Implosive Therapy; D008297:Male; D008875:Middle Aged; D009771:Obsessive-Compulsive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D055815:Young Adult
D018967:Risperidone; D017367:Selective Serotonin Reuptake Inhibitors