Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-30 @ 1:50 AM
Study NCT ID:
NCT00257361
Status:
WITHDRAWN
Last Update Posted:
2013-09-30
First Post:
2005-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
D-Cycloserine Augmentation of Exposure and Response Prevention Treatment for Obsessive-Compulsive Disorder
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
D-Cycloserine Augmentation of Exposure and Response Prevention Treatment for Obsessive-Compulsive Disorder
Status:
WITHDRAWN
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left the university
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We propose to undertake an initial study of DCS to determine whether it has any short-term clinical benefits when added to standard ERP therapy in adults with OCD.
Detailed Description:
Exposure and response prevention (ERP) has proven efficacy for OCD treatment in adults. Yet, ERP does not help all individuals, and those who benefit often remain somewhat symptomatic. Behavioral models for OCD treatment are based on two components. First, fears are acquired by the development of an association between a neutral stimulus and an aversive stimulus such the former acquires the aversive properties of the latter. The neutral stimulus is then designated as a conditioned stimulus (CS), and the original aversive stimulus is called an unconditioned stimulus (UCS). Second, the acquired fears can be unlearned through presentation of the CS in the absence of the UCS, a process known as extinction. On a neural level, ERP incorporates similar mechanisms to those involved in fear conditioning. Antagonists at the glutamatergic NMDA receptor, which is involved in learning and memory, block both fear learning and extinction. D-Cycloserine (DCS), a partial agonist at the N-methyl-D-aspartate (NMDA) glutamate receptor subtype, augments learning in animals and humans. Clinical application in animals and humans suggest that DCS facilitates the fear extinction process when taken prior to exposure to feared stimuli. An initial trial in acrophobic adults provided support for acute DCS dosing as facilitating extinction to fear. Given that ERP is based on extinction, it follows that DCS may augment ERP therapy providing enhanced treatment effects. With this in mind, we propose to undertake an initial study of DCS to determine whether it has any short-term clinical benefits when added to standard ERP therapy in adults with OCD.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 00053428 | None | None | View |