Trial Outcomes & Findings for Treatment of Obsessive Compulsive Disorder in Children (NCT NCT00074815)
NCT ID: NCT00074815
Last Updated: 2014-07-29
Results Overview
OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40). Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure.
COMPLETED
PHASE3
124 participants
Measured at baseline and Week 12.
2014-07-29
Participant Flow
Participant milestones
| Measure |
MM + CBT
Participants will receive medication management plus cognitive behavioral therapy with a psychologist
|
MM + ICBT
Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
|
MM Only
Participants will receive medication management only
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
42
|
|
Overall Study
COMPLETED
|
37
|
34
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Obsessive Compulsive Disorder in Children
Baseline characteristics by cohort
| Measure |
MM + CBT
n=42 Participants
Participants will receive medication management plus cognitive behavioral therapy with a psychologist
|
MM + ICBT
n=40 Participants
Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
|
MM Only
n=42 Participants
Participants will receive medication management only
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
12.71 years
STANDARD_DEVIATION 2.88 • n=5 Participants
|
13.76 years
STANDARD_DEVIATION 2.72 • n=7 Participants
|
14.34 years
STANDARD_DEVIATION 2.51 • n=5 Participants
|
13.6 years
STANDARD_DEVIATION 2.77 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
40 participants
n=7 Participants
|
42 participants
n=5 Participants
|
124 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and Week 12.Population: Intent to treat (all included)
OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40). Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure.
Outcome measures
| Measure |
MM + CBT
n=42 Participants
Participants will receive medication management plus cognitive behavioral therapy with a psychologist
|
MM + ICBT
n=40 Participants
Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
|
MM Only
n=42 Participants
Participants will receive medication management only
|
|---|---|---|---|
|
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
|
0.69 Proportion of Participants with RESPONSE
Interval 0.54 to 0.83
|
0.34 Proportion of Participants with RESPONSE
Interval 0.18 to 0.5
|
0.30 Proportion of Participants with RESPONSE
Interval 0.15 to 0.45
|
SECONDARY outcome
Timeframe: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-upOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-upOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-upOutcome measures
Outcome data not reported
Adverse Events
MM + CBT
MM + ICBT
MM Only
Serious adverse events
| Measure |
MM + CBT
n=42 participants at risk
Participants will receive medication management plus cognitive behavioral therapy with a psychologist
|
MM + ICBT
n=40 participants at risk
Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
|
MM Only
n=42 participants at risk
Participants will receive medication management only
|
|---|---|---|---|
|
Psychiatric disorders
Suicide Attempt that led to hospitalization and changes to medication and therapy
|
0.00%
0/42
|
0.00%
0/40
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Suicidal Thoughts due to school difficulties
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
0.00%
0/42
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place