D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder
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ClinicalTrials.gov Identifier: NCT00864123 |
Recruitment Status :
Completed
First Posted : March 18, 2009
Results First Posted : October 17, 2012
Last Update Posted : October 17, 2012
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Condition or disease | Intervention/treatment | Phase |
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Obsessive-compulsive Disorder | Behavioral: Cognitive-behavioral therapy Drug: D-cycloserine Drug: Placebo pill | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | November 2009 |

Arm | Intervention/treatment |
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Active Comparator: Cognitive-behavioral therapy + placebo
Involves 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).
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Behavioral: Cognitive-behavioral therapy
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). Drug: Placebo pill 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.
Other Name: Pill placebo |
Experimental: Cognitive-behavioral therapy + D-cycloserine
Involves 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).
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Behavioral: Cognitive-behavioral therapy
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). Drug: D-cycloserine 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.
Other Names:
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- Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). [ Time Frame: Baseline, Mid-Treatment, Post-treatment ]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.
- 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. [ Time Frame: Baseline, mid-treatment, post-treatment ]The CGI-S is a 7-point clinician rating of severity of psychopathology. Ratings range from 1 ("no illness") to 7 ("extremely severe"). A single rating is chosen for the CGI-S; thus, there are no summary scales/scores.
- Adverse Symptom Checklist (ASC; Goodman, 2005). [ Time Frame: Baseline, mid-treatment, post-treatment ]This index assesses adverse side effects that have been associated with DCS, as well as other commonly used psychotropic agents (e.g., SRIs). There are no summary scales for this. Rather, it reflects the presence or absence of 30 potential side effects on a 0-3 scale (0=not at all, 1=slight, 2=moderate, 3=severe) that are associated with study interventions.

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Ages Eligible for Study: | 8 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864123
United States, Florida | |
University of South Florida | |
St. Petersburg, Florida, United States, 33701 |
Principal Investigator: | Eric Storch, Ph.D. | University of South Florida |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eric Storch, Associate Professor, University of South Florida |
ClinicalTrials.gov Identifier: | NCT00864123 |
Other Study ID Numbers: |
MH076775 MH076775 |
First Posted: | March 18, 2009 Key Record Dates |
Results First Posted: | October 17, 2012 |
Last Update Posted: | October 17, 2012 |
Last Verified: | September 2012 |
Obsessive-compulsive disorder |
Disease Compulsive Personality Disorder Obsessive-Compulsive Disorder Pathologic Processes Personality Disorders Mental Disorders Anxiety Disorders Cycloserine |
Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |