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Sponsors and Collaborators: |
University of South Florida Indiana University Ortho-McNeil Janssen Scientific Affairs, LLC |
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Information provided by: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT00632229 |
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.
Condition | Intervention | Phase |
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Obsessive-Compulsive Disorder |
Drug: Paliperidone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Recieves study medication
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Drug: Paliperidone
Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
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B: Placebo Comparator
Placebo comparator
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Drug: Paliperidone
Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.
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Obsessive-compulsive disorder (OCD) is a common, chronic, and oftentimes disabling disorder. The only established first-line treatments for OCD are a specific form of Cognitive Behavioral Therapy (CBT) and the Serotonin Reuptake Inhibitors (SRIs). Few patients with OCD experience complete symptom resolution with either modality.
Even after two consecutive adequate 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.
Among the pharmacological augmentation strategies, adjunctive antipsychotic medications enjoy the most empirical support as well as wide-scale use in clinical practice. Utilizing IMS Health's National Disease and Therapeutic Index (NDTI) for 12 months ending in November 2004, 4.2% of antipsychotic medication use is for anxiety and 1.3% specifically for OCD. Conversely, for OCD patients, antipsychotic medications account for 8.6% of drug use (IMS Health NDTI MAT, 2004). Among pediatric patients, prescriptions of antipsychotics increased from 8.6 out of 1,000 U.S. children in 1995-1996 to 39.4 out of 1,000 children in 2001-2002 (Cooper et al., 2006). Similarly, Medco, a private insurance company, noted that the rate of children 19 years and under covered by private insurance with at least one atypical prescription jumped 80% from 2001 to 2005 — from 3.6 per 1,000 to 6.5 per 1,000 (USA Today, extracted 5/2/2006). These rates parallel our own research, in which approximately 35% of adult patients on psychotropics were taking an antipsychotic in addition to their SRI. Thus, clearly there is a large sample of OCD patients that are being prescribed atypical antipsychotics to augment other treatments.
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 (Bloch et al., 2006).
Risperidone has been the most studied agent and has the most consistently positive findings (e.g., McDougle et al., 2000). However, the problematic acute and long-term side effects of risperidone (and other atypicals) are of concern and, at times, limit their use. Paliperidone, a metabolite of risperidone that utilizes OROS osmotic drug-release technology, has a number of advantages over risperidone including a lack of drug x drug interactions and a predictable pharmacokinetic profile that is associated with better tolerability. Thus, paliperidone has the potential to be a safer alternative for augmentation in OCD patients pending supporting efficacy data. Given the need to examine the efficacy of paliperidone, this protocol is designed to determine whether paliperidone augmentation of an SRI is effective relative to a placebo-control, and safe/tolerable in patients with OCD who have not adequately responded to past adequate SRI treatment.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must continue to experience clinically significant symptoms of OCD (Y-BOCS score ≥19 and a rating of "moderate" or greater on the Clinical Global Impressions (CGI) scale) despite at least two adequate SRI monotherapy trials. One unsatisfactory trial can include the SRI currently being taken by the patient provided that the duration of treatment is 12 weeks or more and that the dose has been adequate.
Subjects must be taking a clinically effective dose of a SRI (i.e., clomipramine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) for at least 12 weeks. Subjects must be on their current dose for at least 12 weeks and must maintain their current dose throughout the study.
Exclusion Criteria:
Contact: Eric Storch, Ph.D. | 727-767-8230 | rothmanctr@health.usf.edu |
Contact: Jane Mutch, Ph.D. | 727-767-8230 | pmutch@health.usf.edu |
United States, Florida | |
University of South Florida | Recruiting |
St. Petersburg, Florida, United States, 33701 | |
Contact: Eric A. Storch, Ph.D. 727-767-8230 rothmanctr@health.usf.edu | |
Contact: Jane Mutch, Ph.D. 727-767-8230 pmutch@health.usf.edu | |
Principal Investigator: Eric A. Storch, Ph.D. | |
Sub-Investigator: Tanya K Murphy, M.D. | |
United States, Indiana | |
University Hospital Outpatient Center, Psychiatry | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Carla Medock 317-274-0314 cemedloc@iupui.edu | |
Contact: Andrew Goddard, MD 317-274-0314 | |
Principal Investigator: Andrew Goddard, MD |
Principal Investigator: | Eric A Storch, Ph.D. | University of South Florida |
Responsible Party: | University of South Florida ( Eric Storch, Ph.D. ) |
Study ID Numbers: | USF 08-0100 |
Study First Received: | February 29, 2008 |
Last Updated: | June 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00632229 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Obsessive-Compulsive Disorder; Adults; Medication; Treatment |
Tranquilizing Agents Anxiety Disorders Mental Disorders Psychotropic Drugs Risperidone |
Central Nervous System Depressants 9-hydroxy-risperidone Antipsychotic Agents Obsessive-Compulsive Disorder |
Disease Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants 9-hydroxy-risperidone Antipsychotic Agents |
Pharmacologic Actions Pathologic Processes Anxiety Disorders Mental Disorders Therapeutic Uses Central Nervous System Agents Obsessive-Compulsive Disorder |