Trial Outcomes & Findings for D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder (NCT NCT00864123)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Baseline, Mid-Treatment, Post-treatment

Results posted on

2012-10-17

Participant Flow

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)

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive-behavioral Therapy + Placebo n=15 Participants 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).	Cognitive-behavioral Therapy + D-cycloserine n=15 Participants 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 n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	12.5 years STANDARD_DEVIATION 3.5 • n=5 Participants	11.9 years STANDARD_DEVIATION 1.9 • n=7 Participants	12.2 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive-behavioral Therapy + Placebo n=15 Participants 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).	Cognitive-behavioral Therapy + D-cycloserine n=15 Participants 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).
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). Baseline	26 units on a scale Standard Deviation 3.8	24.1 units on a scale Standard Deviation 4.4
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). Mid-treatment	17.9 units on a scale Standard Deviation 4.5	15.6 units on a scale Standard Deviation 6.8
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). Post-treatment	11 units on a scale Standard Deviation 6.6	6.8 units on a scale Standard Deviation 6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive-behavioral Therapy + Placebo n=15 Participants 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).	Cognitive-behavioral Therapy + D-cycloserine n=15 Participants 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).
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	5.1 units on a scale Standard Deviation .74	4.6 units on a scale Standard Deviation .83
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. Mid-treatment	3.9 units on a scale Standard Deviation .59	3.5 units on a scale Standard Deviation .92
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. Post-treatment	3 units on a scale Standard Deviation 1.2	2 units on a scale Standard Deviation 1

SECONDARY outcome

Timeframe: Baseline, mid-treatment, post-treatment

Population: Number of participants experiencing an adverse effect related to study interventions. This is a simple frequency count.

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.

Outcome measures

Outcome measures
Measure	Cognitive-behavioral Therapy + Placebo n=15 Participants 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).	Cognitive-behavioral Therapy + D-cycloserine n=15 Participants 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).
Adverse Symptom Checklist (ASC; Goodman, 2005). Baseline	0 participants	0 participants
Adverse Symptom Checklist (ASC; Goodman, 2005). Mid-treatment	0 participants	0 participants
Adverse Symptom Checklist (ASC; Goodman, 2005). Post-treatment	0 participants	0 participants

Adverse Events

Cognitive-behavioral Therapy + Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive-behavioral Therapy + D-cycloserine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Storch, Ph.D.

University of South Florida

Phone: 727-767-8230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place