Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
Obsessive-compulsive disorder (OCD) is a common, chronic, and oftentimes disabling disorder.
The only established treatments for OCD are a specific form of Cognitive Behavioral Therapy
(CBT) and the Serotonin Reuptake Inhibitor medications (SRIs). Few patients with OCD
experience complete symptom resolution with either modality and even after two consecutive
SRI trials, as many as 30%-40% of patients fail to derive a satisfactory response.
Pharmacological options for these SRI-resistant cases include switching to a different
antidepressant, increasing the dose of SRI, or augmentation with another agent.
Previous studies showed that approximately 33-50% of OCD patients who have not had an
adequate response to SRI medication had a positive response when an atypical antipsychotic
medication was added. However, the problematic acute and long-term side effects of these
medications are of concern and, at times, limit their use. Paliperidone has a number of
advantages over these medications including fewer drug interactions and better tolerability.
Thus, this study is designed to determine whether paliperidone augmentation of an existing
medication is effective relative to taking a placebo and your existing medication.
Phase:
Phase 2
Details
Lead Sponsor:
University of South Florida
Collaborators:
Indiana University Ortho-McNeil Janssen Scientific Affairs, LLC