D-Cycloserine Augmentation to Cognitive Behavioral Therapy With Exposure and Response Prevention (CBT/ERP) in Adults and Adolescents With Obsessive Compulsive Disorder



Status:Archived
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2008
End Date:December 2010

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Open-Label Exploratory Investigation of D-Cycloserine Augmentation to Cognitive Behavioral Therapy With Exposure and Response Prevention for Adults and Adolescents Diagnosed With Obsessive Compulsive Disorder - A Feasibility Study


This is a single site, open-label, feasibility study of cognitive behavioral therapy with
exposure and response prevention (CBT/ERP) adding the augmentation of D-cycloserine (DCS)
for adults ages of 18-65 and adolescents ages of 12-17 with Obsessive Compulsive Disorder
(OCD) who are partial or non-responders to first line treatments of CBT or pharmacotherapy.


The primary goal of this study is to examine the feasibility and efficacy of DCS
augmentation to CBT/ERP at the end of the session. The main treatment outcome will be
measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The secondary goal of the
study is to investigate the safety of DCS in adults and adolescents with OCD. 10 adults and
18 adolescents will be recruited in this study. Patients who are currently on medication
therapies for OCD must be stable for at least 12 weeks prior to and during the study.

This study consists of a treatment period of up to 5 weeks and a screening period that
contains a 90-minute psycho-educational session. During the treatment period, patients will
receive 60-minute CBT/ERP sessions held twice weekly. At the end of each session, patients
will receive a 50 mg dose of DCS. Following the administration of the DCS, patients will be
asked to do their best not to ritualize and remain on the Children's Day Unit, where they
will be observed and report to the research team if any ritualization has occurred.

After the fifth CBT/ERP session if a patient's Y-BOCS is not less than or equal to 12,
he/she will be offered an additional 5 CBT/ ERP sessions with DCS. Patients with a Y-BOCS
less than or equal to12 will be referred to either their primary treatment clinician or will
be assisted in finding treatment in the community as needed

Present data collected from this protocol show that adolescents who completed and engaged in
treatment experienced benefit to the combination of CBT/ERP and DCS. However, this is an
unblinded study and the adolescents are receiving an intensive form of CBT/ERP with close
monitoring following 2 hours after the administration of the DCS. The positive results may
be due to this specific way in which the CBT/ERP was delivered or to the attention paid to
participants during treatment sessions and monitoring periods. We plan to recruit 3
additional adolescents diagnosed with OCD with history of failed or partial response to at
least one trial of SSRI medication or CBT/ERP. These participants will receive ten sessions
of twice weekly CBT/ERP delivered exactly as it was previously in this protocol but without
DCS administration. If these participants do not significantly improve (CYBOCS score <12)
after this period, they will receive ten additional sessions of twice-weekly CBT/ERP
augmented by DCS administration after each session. The main treatment outcome will be
measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The secondary goal of the
study is to investigate the safety of DCS in adults and adolescents with OCD. Additionally,
we will explore the impact of patient's motivation to change, parental pathology, and family
accommodation on the treatment progress and outcome in adolescents.


We found this trial at
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New York, New York 10032
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New York, NY
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