D-Cycloserine Augmentation to CBT With Exposure and Response Prevention in Adults and Adolescents With OCD
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      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
      adolescents ages 12-17 with Obsessive Compulsive Disorder (OCD) who are partial or
      non-responders to first line treatments of CBT or pharmacotherapy.
    

Detailed description: 
      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 adolescents with OCD. 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 screening period that contains a 90-minute psycho-educational
      session and treatment period of up to 5 weeks. During the treatment period, patients will
      receive ten 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. At
      the end of study participation, all participants will be offered 10 additional sessions of
      twice-weekly ERP without DCS administration. All participants will then complete a follow-up
      visit at 10 weeks after baseline.

      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 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.

      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 recruited 5 additional
      adolescents diagnosed with OCD to serve as control group participants. These individuals all
      had a history of failed or partial response to at least one trial of Selective Serotonin
      Reuptake Inhibitor (SSRI) medication or CBT/ERP. These participants also received ten
      sessions of twice weekly CBT/ERP delivered exactly as it was previously in this protocol, but
      without DCS administration. All control participants completed a follow-up visit at 10 weeks
      after baseline. Due to the small number of control participants, statistical analyses
      comparing the treatment groups were not completed.
    

Intervention name(s): D-cycloserine; Exposure and Response Prevention (EX/RP)
Intervention type(s): Drug; Behavioral
Intervention description(s): 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; Exposure and response prevention treatment. Participants complete graded exposure during twice weekly treatment sessions with therapist
Intervention MeSH terms: Cycloserine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCD; DCS; D-cycloserine; CBT; E/RP; exposure response prevention