Trial Outcomes & Findings for D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD) (NCT NCT01411774)
NCT ID: NCT01411774
Last Updated: 2018-01-23
Results Overview
The Children's Yale-Brown Obsessive-Compulsive Scale measures the severity of OCD symptoms. There are 10 questions that are summed to arrive at a total score, with higher scores representing more severe OCD symptoms (scores range from 0-40).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
142 participants
Primary outcome timeframe
10 weeks
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
Cognitive-behavioral Therapy Plus Pill Placebo
This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.
Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.).
|
Cognitive-behavioral Therapy Plus D-cycloserine
This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.
Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg).
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
70
|
|
Overall Study
COMPLETED
|
72
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cognitive-behavioral Therapy Plus Pill Placebo
This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.
Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.).
|
Cognitive-behavioral Therapy Plus D-cycloserine
This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.
Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD)
Baseline characteristics by cohort
| Measure |
Cognitive-behavioral Therapy Plus Pill Placebo
n=72 Participants
This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.
Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.).
|
Cognitive-behavioral Therapy Plus D-cycloserine
n=70 Participants
This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.
Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg).
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
72 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
142 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
|
12.54 years
STANDARD_DEVIATION 3.04 • n=5 Participants
|
13.05 years
STANDARD_DEVIATION 2.93 • n=7 Participants
|
12.93 years
STANDARD_DEVIATION 2.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksThe Children's Yale-Brown Obsessive-Compulsive Scale measures the severity of OCD symptoms. There are 10 questions that are summed to arrive at a total score, with higher scores representing more severe OCD symptoms (scores range from 0-40).
Outcome measures
| Measure |
Cognitive-behavioral Therapy Plus Pill Placebo
n=72 Participants
This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.
Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.).
|
Cognitive-behavioral Therapy Plus D-cycloserine
n=70 Participants
This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.
Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg).
|
|---|---|---|
|
Children's Yale-Brown Obsessive-Compulsive Scale.
|
13.53 units on a scale
Interval 11.22 to 15.85
|
13.98 units on a scale
Interval 11.6 to 16.36
|
SECONDARY outcome
Timeframe: 10 weeksThe Clinical Global Impression-Severity involves a trained clinician rating how severe the person's OCD symptoms are on a 0 to 6 scale, with higher scores corresponding to more severe symptoms. This rating only involves a clinician completing a single item.
Outcome measures
| Measure |
Cognitive-behavioral Therapy Plus Pill Placebo
n=72 Participants
This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with pill placebo taken 1 hour before the session.
Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
Pill placebo: The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.).
|
Cognitive-behavioral Therapy Plus D-cycloserine
n=70 Participants
This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.
Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg).
|
|---|---|---|
|
Clinical Global Impression-Severity
|
2.23 units on a scale
Interval 1.89 to 2.56
|
2.28 units on a scale
Interval 1.94 to 2.63
|
Adverse Events
Cognitive-behavioral Therapy Plus Pill Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive-behavioral Therapy Plus 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place