Trial Outcomes & Findings for Study of Aripiprazole to Treat Children and Adolescents With Autism (NCT NCT00619190)

NCT ID: NCT00619190

Last Updated: 2014-03-26

Results Overview

The Aberrant Behavior Checklist (ABC) is a caregiver rated questionnaire for assessing problem behaviors of children over the past week relative to typically developing children of the same age. Problem behaviors are rated on a categorical scale between 0 not at all a problem and 3 problem is severe in degree. Raters are instructed to consider both the severity and the frequency of the behavior in determining how severe a problem the behavior is. Thus, if a given behavior occurs more often than in other children of the same age and sex, scores greater than or equal to 1 are warranted. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, higher the number the worse the symptoms.The irritability subscale consists of 15 items with a minimal score of 0 - no irritability problems to 45 - all irritability items rated as severe. A rating of 18 or more on the irritability subscale is considered clinically significant.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Baseline to 12 weeks

Results posted on

2014-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Open Aripipraprazole Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg	no Medication Control group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.
Overall Study STARTED	21	9
Overall Study COMPLETED	20	9
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Aripiprazole to Treat Children and Adolescents With Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Aripipraprazole n=21 Participants Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg	no Medication Control n=9 Participants group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	21 Participants n=93 Participants	9 Participants n=4 Participants	30 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	8.269 years STANDARD_DEVIATION 3.75 • n=93 Participants	11.11 years STANDARD_DEVIATION 4.5 • n=4 Participants	9.542 years STANDARD_DEVIATION 4.272 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	8 Participants n=4 Participants	27 Participants n=27 Participants
Region of Enrollment United States	21 participants n=93 Participants	9 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Only 20 out of 21 total participants were analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.

Outcome measures

Outcome measures
Measure	Open Aripipraprazole n=20 Participants Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg	no Medication Control n=9 Participants group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks	7.6 units on a scale Standard Deviation 9.7	-0.6 units on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.

One of the most widely used of clinician assessment tools in psychiatry, the CGI is an observer-rated scale that measures illness severity (CGI-S). The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients).

Outcome measures

Outcome measures
Measure	Open Aripipraprazole n=20 Participants Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg	no Medication Control n=9 Participants group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
Clinical Global Impressions Scale - Severity Score (CGI-S)	5.35 units on a scale Standard Deviation 0.74	4.5 units on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.

The Aberrant Behavior Checklist lethargy/social withdrawal subscale (ABC-SW) is the sum of ratings from 0 - not a problem at all to 3 - problem is severe in degree on 16 items within the Aberrant Behavior checklist (also described in the primary outcome measure section above). Scores can range from 0 to 48, with higher scores indicating more severe problems. The period for the rating is one week and the reference group is typically developing children of the same age and gender as the participant. Both frequency of the behaviors and severity of the problems related to them are considered. High ratings on these items reflect lack of response and interaction with other people in the child's environment.

Outcome measures

Outcome measures
Measure	Open Aripipraprazole n=20 Participants Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg	no Medication Control n=9 Participants group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks	-4.5 units on a scale Standard Deviation 6.4	-0.3 units on a scale Standard Deviation 2.4

Adverse Events

Open Aripipraprazole

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

no Medication Control

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Linmarie Sikich, MD

UNC Chapel Hill

Phone: 919-972-7499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Open Aripipraprazole n=21 participants at risk Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg	no Medication Control n=9 participants at risk group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
Psychiatric disorders Agitation	9.5% 2/21 • Number of events 21 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Psychiatric disorders Anxiety	9.5% 2/21 • Number of events 21 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	11.1% 1/9 • Number of events 1 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Gastrointestinal disorders Appetite Increased	19.0% 4/21 • Number of events 6 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Gastrointestinal disorders Appetite Decreased	4.8% 1/21 • Number of events 1 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Gastrointestinal disorders Abdominal pain	9.5% 2/21 • Number of events 3 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Psychiatric disorders Depression	4.8% 1/21 • Number of events 1 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
General disorders Insomnia	23.8% 5/21 • Number of events 7 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	11.1% 1/9 • Number of events 1 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Gastrointestinal disorders Encopresis	9.5% 2/21 • Number of events 3 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Infections and infestations Infection	33.3% 7/21 • Number of events 7 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Infections and infestations Fever	4.8% 1/21 • Number of events 1 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	22.2% 2/9 • Number of events 2 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
General disorders Nightmares	0.00% 0/21 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	11.1% 1/9 • Number of events 2 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Ear and labyrinth disorders Vertigo	4.8% 1/21 • Number of events 1 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
General disorders Headache/Migraine	23.8% 5/21 • Number of events 5 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Gastrointestinal disorders Diarrhea	14.3% 3/21 • Number of events 3 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Immune system disorders Allergies	0.00% 0/21 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	22.2% 2/9 • Number of events 2 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Skin and subcutaneous tissue disorders Mouth Sores	0.00% 0/21 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	11.1% 1/9 • Number of events 1 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Skin and subcutaneous tissue disorders acne	9.5% 2/21 • Number of events 2 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.	0.00% 0/9 • Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.