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Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder
NCT00632229 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 144 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00632229 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00632229?
The interventions under investigation include: Placebo (DRUG), Paliperidone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00632229?
This trial is sponsored by University of South Florida, which has 144 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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