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NCT00632229 · ClinicalTrials.gov registry record · Phase 2
Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder
A Phase 2 study of Obsessive - Compulsive Disorder, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 2
- Study locations
NCT00632229 is a Phase 2 study of Obsessive - Compulsive Disorder that has completed, run by University of South Florida. The registered enrollment target is 34 participants, below the 2,064-participant average among 84 other Obsessive - Compulsive Disorder trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00632229, a Phase 2 study of Obsessive - Compulsive Disorder, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Paliperidone
Study Locations (2)
Florida
- University of South Florida - St. Petersburg
Indiana
- University Hospital Outpatient Center, Psychiatry - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00632229
The ClinicalTrials.gov registry entry for NCT00632229 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,064-participant average among 84 other Obsessive - Compulsive Disorder trials with a reported enrollment target (98% lower). The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obsessive - Compulsive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00632229 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT00632229 about?
NCT00632229 is a clinical study titled "Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder". 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 re...
What is the current status of trial NCT00632229?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2007-10. Estimated completion is 2013-09.
What conditions does trial NCT00632229 study?
This clinical trial studies the following conditions: Obsessive - Compulsive Disorder.
What interventions are being tested in trial NCT00632229?
The interventions under investigation include: Placebo (DRUG), Paliperidone (DRUG).
Who is sponsoring clinical trial NCT00632229?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00632229 being conducted?
This trial has 2 study locations across Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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