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Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART) (BAART)

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ClinicalTrials.gov Identifier: NCT01333072
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Autistic Disorder
Interventions Drug: Aripiprazole
Drug: Risperidone
Enrollment 80
Recruitment Details 80 participants were enrolled but 19 dropped from the study due to placebo response (16), parent withdrew child (2) and physician withdrew 1 subject. This left 61 subjects for randomization, as specified
Pre-assignment Details  
Arm/Group Title Risperidone Aripiprazole
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Atypical antipsychotic

Risperidone: Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day.

Atypical antipsychotic

Aripiprazole: The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks.

Period Title: Overall Study
Started 30 31
Completed 24 27
Not Completed 6 4
Reason Not Completed
Lost to Follow-up             3             0
Adverse Event             2             4
Physician Decision             1             0
Arm/Group Title Risperidone Aripiprazole Total
Hide Arm/Group Description

Atypical antipsychotic

Risperidone: Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day (McCracken et al 2002).

Atypical antipsychotic

Aripiprazole: The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 30 31 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants 31 participants 61 participants
8.3
(6.3 to 17.5)
8.5
(6.0 to 15.1)
8.4
(6.0 to 17.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Female
7
  23.3%
6
  19.4%
13
  21.3%
Male
23
  76.7%
25
  80.6%
48
  78.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 31 participants 61 participants
30 31 61
1.Primary Outcome
Title Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks
Hide Description

Multi-center, blinded clinical trial to evaluate biomarkers as predictors of efficacy and safety in children with autistic disorder to risperidone, an atypical antipsychotic drug and aripiprazole, an antipsychotic having a unique clinical and receptor-binding profile.

The major outcome measure was the score on the Irritability subscale of the Aberrant Behavior Checklist (ABC-I) . The ABC has 58 items describing some aspect of behavior and the Irritability sub-scale has 15 items, each completed by a parent or caregiver under the supervision of an investigator. Scores on each item range from 0 = no problem and 3 = severe problem (range of total scores 0 to 45). A fall in scores indicates behavioral improvement.

Time Frame baseline to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Score on Aberrant Behavior Checklist (ABC) scale for Irritability
Arm/Group Title Risperidone Aripiprazole
Hide Arm/Group Description:

Atypical antipsychotic

Risperidone: Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day (McCracken et al 2002).

Atypical antipsychotic

Aripiprazole: The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks.

Overall Number of Participants Analyzed 24 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.7  (3.0) 14.1  (3.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Risperidone Aripiprazole
Hide Arm/Group Description

Atypical antipsychotic

Risperidone: Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day (McCracken et al 2002).

Atypical antipsychotic

Aripiprazole: The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks.

All-Cause Mortality
Risperidone Aripiprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/31 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Risperidone Aripiprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Risperidone Aripiprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   23/30 (76.67%)   19/31 (61.29%) 
Metabolism and nutrition disorders     
weight gain *  21/30 (70.00%)  8/31 (25.81%) 
Psychiatric disorders     
sedation *  2/30 (6.67%)  7/31 (22.58%) 
enuresis *  0/30 (0.00%)  4/31 (12.90%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: C. Lindsay DeVane, Pharm.D.
Organization: MUSouthCarolina
Phone: 8432701818
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01333072     History of Changes
Other Study ID Numbers: R01HD062550-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 20, 2010
First Posted: April 11, 2011
Results First Submitted: July 31, 2018
Results First Posted: September 26, 2018
Last Update Posted: September 26, 2018