CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Paliperidone +1 moredrug
Likely dose
Paliperidone 9mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00632229
NCT00632229Phase 2Completed

Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder

University of South Florida·interventional·Posted Mar 10, 2008·Updated Feb 6, 2014

In Brief

A Phase 2 clinical trial evaluating Paliperidone and Placebo for Obsessive-Compulsive Disorder. Completed, enrolled 34 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2008
Enrollment StartOct 1, 2007
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 18.3 years ago

Interventions

Paliperidonedrug

Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.

Placebodrug

Pill placebo taken daily ranging from 3-9mg/day depending on tolerability and efficacy.