D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 17, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
October 17, 2012
CompletedOctober 17, 2012
September 1, 2012
1.8 years
March 17, 2009
June 26, 2012
September 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997).
The CY-BOCS is a 10-item semi-structured measure of obsession and compulsion severity over the previous week. This measure served as the primary outcome index. Scores range from 0-40 with higher scores representing more severe symptoms.
Baseline, Mid-Treatment, Post-treatment
Secondary Outcomes (2)
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.
Baseline, mid-treatment, post-treatment
Adverse Symptom Checklist (ASC; Goodman, 2005).
Baseline, mid-treatment, post-treatment
Study Arms (2)
Cognitive-behavioral therapy + placebo
ACTIVE COMPARATORInvolves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
Cognitive-behavioral therapy + D-cycloserine
EXPERIMENTALInvolves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
Interventions
All patients will receive 10 sessions of therapy over 8 weeks that is based on the protocol used in POTS (2004). Sessions 1-4 will be held twice weekly; thereafter sessions will be held on a weekly basis. This evidence-based E/RP intervention (POTS, 2004) includes psychoeducation, cognitive training, and exposure and response prevention. By design, this manual provides sufficient flexibility to accommodate the child's developmental needs and address maladaptive parent-child interactions (e.g., accommodation).
D-cycloserine (Seromycin, 250 mg; Eli Lilly and Co, Indianapolis, Indiana) will be capsulated into 25mg with identical placebo capsules. Children weighing between 25-45kg will be given a dosage of 25mg (approximately 0.56-1.0 mg/kg/day). Children weighing between 46-80kg will be given a dosage of 50mg (approximately 0.63-1.08mg/kg/day). DCS or placebo will be given by parents 1 hour prior to psychotherapy sessions (before sessions 4-10 only) based on past success in patients with acrophobia (Ressler et al., 2004) and DCS absorption rates.
This intervention involves taking a placebo pill(s) that matches the d-cycloserine capsules in size, shape, weight, and taste. Placebo contains an no active medication.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Florida
St. Petersburg, Florida, 33701, United States
Related Publications (5)
Storch EA, Murphy TK, Goodman WK, Geffken GR, Lewin AB, Henin A, Micco JA, Sprich S, Wilhelm S, Bengtson M, Geller DA. A preliminary study of D-cycloserine augmentation of cognitive-behavioral therapy in pediatric obsessive-compulsive disorder. Biol Psychiatry. 2010 Dec 1;68(11):1073-6. doi: 10.1016/j.biopsych.2010.07.015.
PMID: 20817153RESULTGuzick AG, Geller DA, Small BJ, Murphy TK, Wilhelm S, Storch EA. Irritability in Children and Adolescents With OCD. Behav Ther. 2021 Jul;52(4):883-896. doi: 10.1016/j.beth.2020.11.001. Epub 2020 Nov 12.
PMID: 34134828DERIVEDStorch EA, McGuire JF, Schneider SC, Small BJ, Murphy TK, Wilhelm S, Geller DA. Sudden gains in cognitive behavioral therapy among children and adolescents with obsessive compulsive disorder. J Behav Ther Exp Psychiatry. 2019 Sep;64:92-98. doi: 10.1016/j.jbtep.2019.03.003. Epub 2019 Mar 9.
PMID: 30877851DERIVEDWilhelm S, Berman N, Small BJ, Porth R, Storch EA, Geller D. D-Cycloserine augmentation of cognitive behavior therapy for pediatric OCD: Predictors and moderators of outcome. J Affect Disord. 2018 Dec 1;241:454-460. doi: 10.1016/j.jad.2018.07.042. Epub 2018 Jul 20.
PMID: 30149332DERIVEDStorch EA, Wilhelm S, Sprich S, Henin A, Micco J, Small BJ, McGuire J, Mutch PJ, Lewin AB, Murphy TK, Geller DA. Efficacy of Augmentation of Cognitive Behavior Therapy With Weight-Adjusted d-Cycloserine vs Placebo in Pediatric Obsessive-Compulsive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Aug 1;73(8):779-88. doi: 10.1001/jamapsychiatry.2016.1128.
PMID: 27367832DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eric Storch, Ph.D.
- Organization
- University of South Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Storch, Ph.D.
University of South Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 17, 2009
First Posted
March 18, 2009
Study Start
January 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
October 17, 2012
Results First Posted
October 17, 2012
Record last verified: 2012-09