Trial Outcomes & Findings for Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder (NCT NCT02048241)
NCT ID: NCT02048241
Last Updated: 2018-06-13
Results Overview
Overall response to treatment is defined as at least a 70% decline in both the Modified Overt Aggression Scale (MOAS) score and the Symptom Checklist-6 (SCL-6) from randomization to end of study. The MOAS measures the severity of explosive overt aggression. The score can range from 0 (no overt aggressive) and it has no theoretical upper limit (incidents could be too many to count). The higher the score, the more serious the aggression; the lower the score, the less serious the aggression. Response to treatment is defined as a 70% or more reduction in the MOAS at the end of the study. The SCL-6 uses 6 subscale items from the larger SCL that measure hostility or irritability on a scale of 1 (not at all) - 5 (definitely). The raw score ranges from 6 (no irritability) to 30 (severe irritability). The lower the score is, the better the outcome. The % decline vary from 0%-100%. A 70% or more decline in the SCL-6 score at the end of study is a response.
COMPLETED
PHASE4
11 participants
up to 8 weeks
2018-06-13
Participant Flow
Participant milestones
| Measure |
Placebo Plus Parent Management Training
Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training
Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
Placebo: Weekly dispensation of pills matching Intuniv but without the active medication
|
Intuniv Plus Parent Management Training
Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training
Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
Intuniv: Weekly administration of medication in doses as per protocol
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Plus Parent Management Training
Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training
Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
Placebo: Weekly dispensation of pills matching Intuniv but without the active medication
|
Intuniv Plus Parent Management Training
Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training
Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
Intuniv: Weekly administration of medication in doses as per protocol
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder
Baseline characteristics by cohort
| Measure |
Placebo Plus Parent Management Training
n=5 Participants
Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training
Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
Placebo: Weekly dispensation of pills matching Intuniv but without the active medication
|
Intuniv Plus Parent Management Training
n=6 Participants
Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training
Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
Intuniv: Weekly administration of medication in doses as per protocol
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 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
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeksOverall response to treatment is defined as at least a 70% decline in both the Modified Overt Aggression Scale (MOAS) score and the Symptom Checklist-6 (SCL-6) from randomization to end of study. The MOAS measures the severity of explosive overt aggression. The score can range from 0 (no overt aggressive) and it has no theoretical upper limit (incidents could be too many to count). The higher the score, the more serious the aggression; the lower the score, the less serious the aggression. Response to treatment is defined as a 70% or more reduction in the MOAS at the end of the study. The SCL-6 uses 6 subscale items from the larger SCL that measure hostility or irritability on a scale of 1 (not at all) - 5 (definitely). The raw score ranges from 6 (no irritability) to 30 (severe irritability). The lower the score is, the better the outcome. The % decline vary from 0%-100%. A 70% or more decline in the SCL-6 score at the end of study is a response.
Outcome measures
| Measure |
Placebo Plus Parent Management Training
n=5 Participants
Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training
Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
Placebo: Weekly dispensation of pills matching Intuniv but without the active medication
|
Intuniv Plus Parent Management Training
n=6 Participants
Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training
Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
Intuniv: Weekly administration of medication in doses as per protocol
|
|---|---|---|
|
Number of Participants That Were Responders
|
0 Participants
|
5 Participants
|
Adverse Events
Placebo Plus Parent Management Training
Intuniv Plus Parent Management Training
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Plus Parent Management Training
n=5 participants at risk
Pills matching Intuniv Tablets without active medication combined with weekly Parent Management Training
Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
Placebo: Weekly dispensation of pills matching Intuniv but without the active medication
|
Intuniv Plus Parent Management Training
n=6 participants at risk
Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training
Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
Intuniv: Weekly administration of medication in doses as per protocol
|
|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/5
|
50.0%
3/6 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Irritability
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
Additional Information
Stephen J. Donovan, MD
New York State Psychiatric Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place