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

NCT01172873 | Completed Results

• 1 other identifier: #5828
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive Compulsive Disorder

Keywords

OCD; DCS; D-cycloserine; CBT; E/RP; exposure response prevention

Outcome Measures

Primary Outcomes (1)

• Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents

  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.

  baseline, visit 5, visit 10, follow-up visit

Secondary Outcomes (2)

• Multidimensional Anxiety Scale for Children (MASC)

  baseline, visit 5, visit 10, follow-up visit

• Beck Depression Inventory (BDI)

  baseline, visit 5, visit 10, follow-up visit

Study Arms (2)

DCS + Exposure and Response Prevention

ACTIVE COMPARATOR

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; Behavioral: Exposure and Response Prevention (EX/RP)

E/RP alone (no DCS administration)

ACTIVE COMPARATOR

Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions.

Drug: D-cycloserine; Behavioral: Exposure and Response Prevention (EX/RP)

Interventions

D-cycloserine DRUG

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

DCS + Exposure and Response Prevention; E/RP alone (no DCS administration)

Exposure and Response Prevention (EX/RP) BEHAVIORAL

Exposure and response prevention treatment. Participants complete graded exposure during twice weekly treatment sessions with therapist

DCS + Exposure and Response Prevention; E/RP alone (no DCS administration)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Patients must be ages of 12-17 at the time of consent.
• Both patients and parents must be able to speak and understand English.
• Written informed assent by the patient and consent by the parent.
• Ability and willingness to comply with study treatment and to attend study assessments.
• Patients must be physically healthy males or non-pregnant females. Females of childbearing potential must comply with contraceptive restrictions noted in the protocol.
• 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
• For patients with attention-deficit hyperactivity disorder (ADHD), the condition must be stable for 4 weeks on present treatment prior to screening.
• 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.
• Patients who failed to respond to either CBT/ERP treatment or a SRI medication (as evidenced by a CY-BOCS score \> 16).
• Based on history, the patient is unlikely to require a change in medication during the course of CBT/ERP + DCS treatment.
• Patients with any clinically significant abnormalities in laboratory parameters at screening.
• Clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease (for example, severe asthma, uncontrolled diabetes mellitus).
• 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.
• 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.
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Emory University: collaborator

Study Sites (1)

New York State Psychiatric Institute/Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Due to small sample size of treatment groups, analyses comparing groups were not conducted. Therefore, we cannot conclude that findings were due to D-cycloserine (DCS) augmentation. All participants received treatment from the same therapist.

Results Point of Contact

• Title: Moira A. Rynn, M.D.
• Organization: New York State Psychiatric Institute/Columbia University

RynnM@nyspi.columbia.edu

646-774-5805

Study Officials

• Moira A Rynn, M.D.

  NYSPI / CU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: July 30, 2010
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 19, 2014
• Results First Posted: December 23, 2013

Record last verified: 2014-01

Locations

US (1)