D-Cycloserine Augmentation to CBT With Exposure and Response Prevention in Adults and Adolescents With OCD

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01172873
First received: April 20, 2009
Last updated: August 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Obsessive Compulsive Disorder
Drug: D-cycloserine
Behavioral: Exposure and Response Prevention (EX/RP)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents [ Time Frame: baseline, visit 5, visit 10, follow-up visit ] [ Designated as safety issue: No ]
    The CYBOCS is a semi-structured measure of Obsessive Compulsive Disorder (OCD) severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20.The CYBOCS differs from the adult Yale-Brown Obsessive Compulsive Scale (YBOCS) only in its use of simpler language. CYBOCS scores range from 0-40, with higher scores representing greater severity of symptoms. The CYBOCS will be administered by independent evaluators (IEs) at baseline, session 5, session 10 and the follow-up visit. It will be the primary outcome measure. The CYBOCS checklist will be used to determine symptom dimensions.


Secondary Outcome Measures:
  • Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: baseline, visit 5, visit 10, follow-up visit ] [ Designated as safety issue: No ]
    Multidimensional Anxiety Scale for Children (MASC): This is a 39-item self-report that measures anxiety symptoms. It provides a total score, as well as 10 subscales, although only total scores will be analyzed. MASC scores range from 0-117, with higher scores representing greater severity of anxiety symptoms. The MASC and will be administered at baseline, session 5, session 10 and the follow-up visit for adolescents.

  • Beck Depression Inventory (BDI) [ Time Frame: baseline, visit 5, visit 10, follow-up visit ] [ Designated as safety issue: Yes ]
    Beck's Depression Inventory (BDI): This is a 21-item self report that measures depression symptoms and will be used for both adults and adolescents at baseline, session 5, session 10 and the follow-up visit. BDI-II scores range from 0-63, with higher scores representing greater severity of depression symptoms.


Enrollment: 16
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DCS + Exposure and Response Prevention
Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held.
Drug: D-cycloserine
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
Behavioral: Exposure and Response Prevention (EX/RP)
Exposure and response prevention treatment. Participants complete graded exposure during twice weekly treatment sessions with therapist
Active Comparator: E/RP alone (no DCS administration)
Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions.
Drug: D-cycloserine
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
Behavioral: Exposure and Response Prevention (EX/RP)
Exposure and response prevention treatment. Participants complete graded exposure during twice weekly treatment sessions with therapist

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Exclusion Criteria

Inclusion Criteria:

  1. Patients must be ages of 12-17 at the time of consent.
  2. Both patients and parents must be able to speak and understand English.
  3. Written informed assent by the patient and consent by the parent.
  4. Ability and willingness to comply with study treatment and to attend study assessments.
  5. Patients must be physically healthy males or non-pregnant females. Females of childbearing potential must comply with contraceptive restrictions noted in the protocol.
  6. Patients must fulfill Diagnostic and Statistical Manual (DSM-IV) criteria for OCD, and OCD must be the primary disorder with a CY-BOCS score > 16
  7. For patients with attention-deficit hyperactivity disorder (ADHD), the condition must be stable for 4 weeks on present treatment prior to screening.
  8. For patients receiving treatment with an FDA approved Serotonin Reuptake Inhibitor (SRI), the medication dose must be stable for at least 12 weeks prior to enrollment.
  9. Patients who failed to respond to either CBT/ERP treatment or a SRI medication (as evidenced by a CY-BOCS score > 16).
  10. Based on history, the patient is unlikely to require a change in medication during the course of CBT/ERP + DCS treatment.

Exclusion Criteria:

  1. Patients with any clinically significant abnormalities in laboratory parameters at screening.
  2. Clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease (for example, severe asthma, uncontrolled diabetes mellitus).
  3. History of schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according to DSM-IV criteria (using the Anxiety Disorders Interview Schedule (ADIS-R) assessment interview), except for patients with a diagnosis of ADHD and/or other anxiety disorders as secondary diagnoses.
  4. Patients who have a history suggestive of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infection (PANDAS). - i.e., a sudden onset or exacerbation of symptoms temporally associated with a preceding streptococcal infection with first onset prior to puberty.
  5. Patients who are receiving formal psychotherapy, other than the one delivered in the study, whether or not the focus of the therapy is on their OCD.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172873

Locations
United States, New York
New York State Psychiatric Institute/Columbia University
New York City, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Emory University
Investigators
Principal Investigator: Moira A Rynn, M.D. NYSPI / CU
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01172873     History of Changes
Other Study ID Numbers: #5828
Study First Received: April 20, 2009
Results First Received: December 18, 2012
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
OCD
DCS
D-cycloserine
CBT
E/RP
exposure response prevention

Additional relevant MeSH terms:
Compulsive Personality Disorder
Disease
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Pathologic Processes
Personality Disorders
Cycloserine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antibiotics, Antitubercular
Antimetabolites
Antitubercular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014