D-Cycloserine Augmentation of Exposure and Response Prevention Treatment for Obsessive-Compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

Official title:

D-Cycloserine Augmentation of Exposure and Response Prevention Treatment for Obsessive-Compulsive Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00257361
• Other study ID #: IRB Protocol #639-2004
• Secondary ID: 00053428
• Status: Withdrawn
• Phase: Phase 2
• First received: November 18, 2005
• Last updated: September 27, 2013
• Start date: July 2005

Study information

• Verified date: August 2011
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. a principal diagnosis of OCD assigned at pre-treatment, derived from the ADIS-IV, with a clinical severity rating of 4 or above;

2. 18-65 years of age; and,

3. an IQ of ³ 80.

Exclusion Criteria:

1. positive diagnosis of schizophrenia, other psychotic disorder, pervasive developmental disorder, organic brain syndrome, or mental retardation;

2. do not speak English;

3. are unwilling to attend twice weekly sessions; or,

4. is pregnant, breast feeding a child, or attempting to become pregnant (see below rationale)

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• D-Cycloserine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Obsessive Compulsive Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	YBOCS
Secondary	Response rate