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Trial record 98 of 531 for:    Taste Disorders

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
Sponsor:
Information provided by (Responsible Party):
Eric Storch, University of South Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obsessive-compulsive Disorder
Interventions Behavioral: Cognitive-behavioral therapy
Drug: D-cycloserine
Drug: Placebo pill
Enrollment 30
Recruitment Details  
Pre-assignment Details Excluded (n = 22) Not interested in participating in study (n=9) Changing medication at Baseline (n=5) Did not receive at least one DCS dose (n = 4) History of adequate CBT course (n=2) Met criteria for comorbid autism (n=1) Did not show up for pre-treatment assessment (n=1)
Arm/Group Title Cognitive-behavioral Therapy + Placebo Cognitive-behavioral Therapy + D-cycloserine
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Cognitive-behavioral Therapy + Placebo Cognitive-behavioral Therapy + D-cycloserine Total
Hide Arm/Group Description 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). 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). Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
15
 100.0%
15
 100.0%
30
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
12.5  (3.5) 11.9  (1.9) 12.2  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
6
  40.0%
5
  33.3%
11
  36.7%
Male
9
  60.0%
10
  66.7%
19
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997).
Hide Description 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.
Time Frame Baseline, Mid-Treatment, Post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-behavioral Therapy + Placebo Cognitive-behavioral Therapy + D-cycloserine
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 26  (3.8) 24.1  (4.4)
Mid-treatment 17.9  (4.5) 15.6  (6.8)
Post-treatment 11  (6.6) 6.8  (6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive-behavioral Therapy + Placebo, Cognitive-behavioral Therapy + D-cycloserine
Comments Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CY-BOCS Total Score) fixed-effects linear regression with time as the repeated measure. Cohen’s d was used to examine the magnitude of treatment effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.0
Parameter Dispersion
Type: Standard Deviation
Value: 6.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Baseline, mid-treatment, post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-behavioral Therapy + Placebo Cognitive-behavioral Therapy + D-cycloserine
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.1  (.74) 4.6  (.83)
Mid-treatment 3.9  (.59) 3.5  (.92)
Post-treatment 3  (1.2) 2  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive-behavioral Therapy + Placebo, Cognitive-behavioral Therapy + D-cycloserine
Comments Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CGI-Severity) fixed-effects linear regression with time as the repeated measure. Cohen’s d was used to examine the magnitude of treatment effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3
Parameter Dispersion
Type: Standard Deviation
Value: 1.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Adverse Symptom Checklist (ASC; Goodman, 2005).
Hide Description 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.
Time Frame Baseline, mid-treatment, post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants experiencing an adverse effect related to study interventions. This is a simple frequency count.
Arm/Group Title Cognitive-behavioral Therapy + Placebo Cognitive-behavioral Therapy + D-cycloserine
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: participants
Baseline 0 0
Mid-treatment 0 0
Post-treatment 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description This metric refers to the number of youth experiencing an adverse event associated with study interventions.
 
Arm/Group Title Cognitive-behavioral Therapy + Placebo Cognitive-behavioral Therapy + D-cycloserine
Hide Arm/Group Description 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). 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).
All-Cause Mortality
Cognitive-behavioral Therapy + Placebo Cognitive-behavioral Therapy + D-cycloserine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive-behavioral Therapy + Placebo Cognitive-behavioral Therapy + D-cycloserine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cognitive-behavioral Therapy + Placebo Cognitive-behavioral Therapy + D-cycloserine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Eric Storch, Ph.D.
Organization: University of South Florida
Phone: 727-767-8230
Responsible Party: Eric Storch, University of South Florida
ClinicalTrials.gov Identifier: NCT00864123     History of Changes
Other Study ID Numbers: MH076775
MH076775
First Submitted: March 17, 2009
First Posted: March 18, 2009
Results First Submitted: June 26, 2012
Results First Posted: October 17, 2012
Last Update Posted: October 17, 2012