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

Contact name: Dr. Eric Storch

Phone: (352)-392-3611

Fax: (352)-846-1455

Email: estorch@psychiatry.ufl.edu

Disorder: Obsessive-Compulsive Disorder

Geographic location: Gainesville Florida

Other keywords: Obsessive-compulsive disorder; cognitive-behavioral therapy

Participant compensation: Participants will receive $40.00 for completing the psychiatric evaluations immediately before and after Exposure and Response Prevention therapy, and three-months after completion of therapy. Participants will receive $10.00 each for completing each of the six shorter assessments that take place during therapy. Thus, participants can receive a total of $180.00. D-Cycloserine will be provided, along with psychiatric evaluations, at no charge.

Time commitment required: Once weekly 90-minute sessions. The study evaluations will take about 2 hours each for longer evaluations (6 hours total) and 20 minutes for shorter bi-session evaluations.

Drug trial: Yes

Recruitment end date (approximate): January 18, 2006

Study criteria (i.e., age or gender requirements):
All patients must meet the following inclusion criteria to be eligible for study participation: (a) a principal diagnosis of OCD assigned at pre-treatment, derived from the ADIS-IV, with a clinical severity rating of 4 or above; (b) 18-65 years of age; (c) an IQ of ³ 80.

Exclusion criteria:
Patients will be excluded from the study if they meet any of the following criteria: (a) positive diagnosis of schizophrenia, other psychotic disorder, pervasive developmental disorder, organic brain syndrome, or mental retardation; (b) do not speak English; (c) are unwilling to attend twice weekly sessions; (d) is pregnant, breast feeding a child, or attempting to become pregnant. Medication is not an exclusion criteria for participation. That is, an adult can be enrolled within the study if they are currently taking medication for their OCD (e.g., an SSRI). However, adults must not have had a medication change in a SSRI within one month of beginning this protocol. If such a change occurred, the patient will be offered the standard of care outside of the treatment protocol.

Brief description of study:
Cognitive-behavioral therapy (CBT) with exposure and response prevention (E/RP) has proven efficacy for treatment of obsessive-compulsive disorder (OCD) in children and adolescents. Yet, CBT does not help all individuals, and those who benefit often remain symptomatic upon treatment completion. The behavioral theory that underlies CBT with E/RP is based on two components, namely fear conditioning and extinction. On a neural level, CBT with E/RP incorporates similar mechanisms to those involved in fear conditioning. Antagonists at the N-methyl-D-aspartate (NMDA) glutamatergic receptor, which is involved in learning and memory, block both fear learning and extinction. Evidence suggests that D-Cycloserine (DCS), a partial agonist at the NMDA glutamate receptor, augments learning in animals and humans. A recent clinical trial in adults with a height phobia (acrophobia) provided support for acute DCS dosing as facilitating extinction to fear during virtual reality exposure therapy. Given that CBT with E/RP is based on the principles of extinction, it follows that DCS may augment this therapy providing enhanced treatment effects for youth with OCD. With this in mind, we are conducting a pilot study of DCS to determine if it has any short-term clinical benefits on CBT in adults with OCD. Forty adults with OCD will be randomly assigned to one of two treatment conditions: (1) CBT plus DCS (250mg), or (2) CBT plus placebo. All patients will receive 12 sessions of CBT therapy. You will undergo nine psychiatric evaluations. Three of the assessments (Pre-treatment, Post-treatment, 3-month follow-up) will be comprehensive in nature (e.g., diagnostic interview, self-reports, Y-BOCS), whereas six will involve administration of Y-BOCS only and take place every second CBT session.

Additional information:
Potential participants must be willing/able to attend weekly sessions in Gainesville Florida.