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

Completed · Not applicable

Conditions studied: Obsessive Compulsive Disorder

In brief

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.

Key facts

Study ID

NCT01172873

Run by

New York State Psychiatric Institute

People needed

16

Starts

2008-09-01

Expected to finish

2010-12-01

Last updated by the study team

2014-08-19

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may 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.

You may not qualify if…

• 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.

Where it is running

• New York State Psychiatric Institute/Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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