Ignite Creation Date:
2024-05-05 @ 9:57 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00994786
Status:
COMPLETED
Last Update Posted:
2019-06-18
First Post:
2009-10-05
Brief Title:
A Study of Pregabalin Lyrica Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive Compulsive Disorder
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
A Study of Pregabalin Lyrica Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive Compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2019-06
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:
This study will examine the efficacy of pregabalin Lyrica added to SRI treatment in OCD for individuals who have not responded or only partially responded to an adequate trial of SRI Although SRIs have demonstrated efficacy in OCD in numerous placebo-controlled trials response rates have been as low as 40 Augmentation strategies would be beneficial to maximize treatment response in OCD
Pregabalin Lyrica is an anticonvulsant medication that appears to have a novel mechanism of action It has been shown to enhance activity at gamma-amino-butyric acid GABA receptors as well as inhibit glutamate release These two neurotransmitters systems have been implicated in the neurobiology of OCD
The study will consist of patients who have not attained full response to an SRI The patients will be randomized in a double-blind fashion to augmentation with pregabalin Lyrica or placebo The dose of study medication will be flexible starting at 75 mgday and increasing in 75 mg increments to a maximum of 600 mgday based on efficacy and any side effects Patients response to treatment will be measured by the Yale-Brown Obsessive-Compulsive Scale Y-BOCS the Montgomery Asberg Depression Rating Scale MADRS and the Clinical Global Impression ScaleCGI
Pregabalin Lyrica is an anticonvulsant medication that appears to have a novel mechanism of action It has been shown to enhance activity at gamma-amino-butyric acid GABA receptors as well as inhibit glutamate release These two neurotransmitters systems have been implicated in the neurobiology of OCD
The study will consist of patients who have not attained full response to an SRI The patients will be randomized in a double-blind fashion to augmentation with pregabalin Lyrica or placebo The dose of study medication will be flexible starting at 75 mgday and increasing in 75 mg increments to a maximum of 600 mgday based on efficacy and any side effects Patients response to treatment will be measured by the Yale-Brown Obsessive-Compulsive Scale Y-BOCS the Montgomery Asberg Depression Rating Scale MADRS and the Clinical Global Impression ScaleCGI
Detailed Description:
None
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