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Randomized Controlled Trial
. 2015 Apr;76(4):440-6.
doi: 10.4088/JCP.14m09044.

Six-month outcomes from a randomized trial augmenting serotonin reuptake inhibitors with exposure and response prevention or risperidone in adults with obsessive-compulsive disorder

Edna B Foa  1 , Helen Blair Simpson, David Rosenfield, Michael R Liebowitz, Shawn P Cahill, Jonathan D Huppert, James Bender Jr, Carmen P McLean, Michael J Maher, Raphael Campeas, Chang-Gyu Hahn, Patricia Imms, Anthony Pinto, Mark B Powers, Carolyn I Rodriguez, Page E Van Meter, Donna Vermes, Monnica T Williams
Affiliations
Randomized Controlled Trial

Six-month outcomes from a randomized trial augmenting serotonin reuptake inhibitors with exposure and response prevention or risperidone in adults with obsessive-compulsive disorder

Edna B Foa et al. J Clin Psychiatry. 2015 Apr.

Abstract

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.

Method: 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.

Trial registration: ClinicalTrials.gov identifier: NCT00389493.

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Conflict of interest statement

Conflict of Interest/Financial Disclosures: The remaining authors report no competing interests.

Figures

Figure 1
Figure 1. Flow Chart of Patients in Study
* Reasons for not completing maintenance: EX/RP: increasing depression (n=1); wanted to change SRI medication (n=1), unable to travel to site (n=1), lost to follow-up (n=1); Risperidone: side effects too great (n=2); increasing depression (n=2); lost to follow-up (n=1)
Figure 2
Figure 2. Change in Severity of Obsessive-Compulsive Disorder
Plot of the piecewise growth curve for the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for patients receiving EX/RP (n=40) or risperdone (n=40). At the end of the Maintenance Phase, those randomized to EX/RP had significantly lower mean Y-BOCS scores (Week 32: b=7.75, P=.009). Slopes during the Maintenance Phase did not differ (Weeks 8–32: b=.12, P=.276).
See this image and copyright information in PMC

References

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