Phase 2
N=30
D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder
Obsessive-compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00864123 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). — 26; 24.1; 17.9; 15.6 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cognitive-behavioral therapy (Behavioral); D-cycloserine (Drug); Placebo pill (Drug)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). |
26; 24.1; 17.9; 15.6; 11; 6.8 | <0.05 sig |
| SECONDARY Clinical Global Impression - Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology. |
5.1; 4.6; 3.9; 3.5; 3; 2 | <0.05 sig |
| SECONDARY Adverse Symptom Checklist (ASC; Goodman, 2005). |
0; 0; 0; 0; 0; 0 | — |
Summary
Cognitive-behavioral therapy (CBT) has proven efficacy for treatment of pediatric obsessive-compulsive disorder (OCD). Yet, CBT does not help all children and those who benefit often remain symptomatic upon treatment completion. Recent clinical trials in adults with other anxiety disorders (acrophobia and social phobia) provided support for using a medication called D-Cycloserine (DCS) to enahnce the outcome of exposure-based psychotherapy. Given this, DCS may augment CBT in youth with OCD, an anxiety disorder that is conceptually similar to acrophobia. With this in mind, the investigators are conducting a randomized, double-blind placebo controlled pilot study of DCS to determine whether it had any short-term clinical benefits on CBT in youth with OCD. Forty children and adolescents (ages 8-17) with a primary diagnosis of OCD will be screened and, should they meet relevant criteria, randomly assigned to one of two treatment conditions: (1) CBT plus DCS, or (2) CBT plus placebo. All patients will receive 10 sessions of CBT A rater will assess participants at 3 separate time points.
Eligibility Criteria
Inclusion Criteria
- The child must receive a principal diagnosis of OCD at Baseline, based on DSM-IV criteria. This diagnosis will be derived from the Anxiety Disorder Interview Schedule for DSM-IV-Child Interview Schedule - Parent version (ADIS-IV-P), and must reflect a clinical severity rating of 4 or above
- CY-BOCS Total Score ≥ 16
- Be between the ages of 8 and 17 years
- Score ≥ 80 on the Peabody Picture Vocabulary Test-3rd Edition (Dunn & Dunn, 1997)
- At least one parent available to accompany the child to all sessions;
- English speaking.
Exclusion Criteria
- Psychosis, pervasive developmental disorder, bipolar disorder, or current suicidal intent measured by the ADIS-IV-P and all available clinical information
- Principal diagnosis other than OCD
- Youth with mental rituals, incompleteness, or hoarding symptoms as E/RP exercises would be more difficult to conduct/monitor than those with overt rituals
- Unavailability of at least one caregiver to participate in the treatment
- Refusal of parent to accept random assignment to treatment condition
- A positive diagnosis in the caregiver of mental retardation, psychosis, clinically significant tics, or other psychiatric disorders or conditions that would limit their ability to understand E/RP (based on clinical interview)
- Weight less than 25.0 kg or greater than 80.0kg
- Epilepsy, renal insufficiency, and current or past history of alcohol abuse (DCS is contraindicated for such conditions)
- Pregnant or having unprotected sex [in females] as the effects of DCS on pregnant youth are unknown
- General poor physical health as determined by medical physical and laboratory tests.
Data sourced from ClinicalTrials.gov (NCT00864123). 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.