N/A
N=16
D-Cycloserine Augmentation to CBT With Exposure and Response Prevention in Adults and Adolescents With OCD
Obsessive Compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01172873 ↗Enrolled (actual)
16
Serious AEs
12.5%
Results posted
Dec 2013
Primary outcome: Primary: Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents — 26.56; 27.25; 22.44; 19.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- D-cycloserine (Drug); Exposure and Response Prevention (EX/RP) (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents |
26.56; 27.25; 22.44; 19.8; 19.67; 17.2 | — |
| SECONDARY Multidimensional Anxiety Scale for Children (MASC) |
42.67; 52.4; 40.56; 47.4; 39.33; 46.8 | — |
| SECONDARY Beck Depression Inventory (BDI) |
13.11; 12.5; 11.33; 4.8; 9.67; 4 | — |
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.
Eligibility Criteria
Inclusion/Exclusion Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01172873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.