D-Cycloserine Augmentation to CBT With Exposure and Response Prevention in Adults and Adolescents With OCD
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS and CY-BOCS for adolescents) [ Time Frame: Treatment Session 10 ] [ Designated as safety issue: No ]
- Multidimensional Anxiety Scale for Children (MASC)- for Adolescents only [ Time Frame: Treatment Sessions 10 ] [ Designated as safety issue: No ]
- Beck Depression Inventory (BDI) [ Time Frame: Treatment Sessions 10 ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: D-cycloserine + E/RP||
50 mg dose of D-cycloserine administered at the end of each session of Cognitive Behavioral Therapy With Exposure and Response Prevention: twice weekly CBT/ERP of 60 minutes
Therapy treatment without D-Cycloserine
Cognitive Behavioral Therapy With Exposure and Response Prevention: twice weekly CBT/ERP of 60 minutes
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.
|United States, New York|
|New York State Psychiatric Institute/Columbia University|
|New York City, New York, United States, 10032|
|Principal Investigator:||Moira A Rynn, M.D.||NYSPI / CU|