Ignite Creation Date:
2024-05-05 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00632229
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2008-02-29
Brief Title:
Double Blinded Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
Double Blinded Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 Healths National Disease and Therapeutic Index NDTI for 12 months ending in November 2004 42 of antipsychotic medication use is for anxiety and 13 specifically for OCD Conversely for OCD patients antipsychotic medications account for 86 of drug use IMS Health NDTI MAT 2004 Among pediatric patients prescriptions of antipsychotics increased from 86 out of 1000 US children in 1995-1996 to 394 out of 1000 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 36 per 1000 to 65 per 1000 USA Today extracted 522006 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 eg 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 safetolerable in patients with OCD who have not adequately responded to past adequate SRI treatment
Among the pharmacological augmentation strategies adjunctive antipsychotic medications enjoy the most empirical support as well as wide-scale use in clinical practice Utilizing IMS Healths National Disease and Therapeutic Index NDTI for 12 months ending in November 2004 42 of antipsychotic medication use is for anxiety and 13 specifically for OCD Conversely for OCD patients antipsychotic medications account for 86 of drug use IMS Health NDTI MAT 2004 Among pediatric patients prescriptions of antipsychotics increased from 86 out of 1000 US children in 1995-1996 to 394 out of 1000 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 36 per 1000 to 65 per 1000 USA Today extracted 522006 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 eg 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 safetolerable in patients with OCD who have not adequately responded to past adequate SRI treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None