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N/A N=100 Randomized Quadruple-blind Treatment

Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder

Obsessive-Compulsive Disorder

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) — 26.1; 27.2; 25.9; 22.6 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Risperidone (Drug); Exposure/ritual prevention therapy (EX/RP) (Behavioral); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
New York State Psychiatric Institute
Primary completion
Jun 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
26.1; 27.2; 25.9; 22.6; 13.0; 23.1
SECONDARY
Social Adjustment Scale-SR
2.3; 2.3; 2.2; 2.2; 1.9; 2.1
SECONDARY
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form
52.3; 57.8; 56.1; 55.1; 70.2; 62.6
SECONDARY
Hamilton Depression Rating Scale (Ham-D)
9.8; 7.8; 7.7; 8.0; 7.8; 7.7
SECONDARY
Brown Assessment of Beliefs (BABS)
5.7; 6.1; 5.3; 4.5; 2.4; 4.3

Summary

This study will compare the short- and long-term effectiveness of two common therapies in improving serotonin reuptake inhibitor treatment in people with obsessive-compulsive disorder.

Eligibility Criteria

Inclusion Criteria

  • Primary diagnosis of OCD
  • Currently on a stable and adequate dose of an SRI
  • Sufficient severity of symptoms to warrant additional augmentation treatment

Exclusion Criteria

  • Medical or psychiatric conditions that would make participation in the study unsafe
  • Currently receiving psychotherapy elsewhere at the time of study entry
  • Previously (within 12 weeks prior to study entry) attended 8 or more sessions of EX/RP within a 2-month period or received at least 4 weeks of antipsychotic augmentation while on an adequate SRI dose
  • Currently being treated with an SRI for the first time and has not yet responded, but has not tried another SRI
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00389493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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