This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of aripiprazole flexible-dosed in children and adolescents with a diagnosis of Autistic Disorder. Approximately 100 subjects will be randomly assigned at a 1:1 ratio to receive aripiprazole (2 to 15 mg) or placebo treatment for 8 weeks
Screening Phase: up to 42 days (consisting of a Screening Visit (V1), a washout period and Interim Screening Visit (V1a) when applicable, and a Baseline Visit (V2). The Screening Phase will serve multiple purposes: to allow for appropriate washout of prohibited medications; to allow for review of screening data; to establish a pre-treatment baseline of key outcome measures. Treatment Phase: The duration of the treatment is 8 weeks. The purpose of the treatment phase is to evaluate the efficacy, safety, tolerability and steady-state plasma trough concentration of aripiprazole in the treatment of serious behavioral problems in children and adolescents with a diagnosis of Autistic Disorder.. Safety Follow-up Phase: All subjects will be followed up for safety (adverse events) at Day 16 after the last medication via telephone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
111
Aripiprazole 2\~15 mg/day (2\~15 mL/day)
Placebo 2\~15 mg/day (2\~15 mL/day)
6th affiliated hospital, Peking University
Beijing, Beijing Municipality, China
Changes from Baseline to Week 8 (or endpoint) in the ABC-I score
The objective of the primary analysis is to compare the efficacy of aripiprazole flexible-dosed (2 \~ 15 mg/day) with placebo in reducing serious behavioral problems, specifically irritability, agitation and self-injurious behavior, in children and adolescents with a diagnosis of Autistic Disorder. The efficacy is assessed by assessed by change from baseline to endpoint on the Irritability Subscale of the ABC (ABC-I).
Time frame: Baseline and 8 weeks (or endpoint)
Clinician-rated CGI-I score at Week 8 (or endpoint)
The efficacy is assessed by the clinician-rated CGI-I score at Week 8
Time frame: Baseline and 8 weeks (or endpoint)
Change in ABC subscale scores from Baseline to Week 8 (or endpoint)
The efficacy is assessed by changes from Baseline to Week 8 (or endpoint) in Social Withdrawal, Hyperactivity, Stereotypy and Inappropriate Speech Subscale scores of the ABC
Time frame: Baseline and 8 weeks (or endpoint)
Response Rate at Week 8 (or endpoint) (or endpoint)
The response is defined as a reduction ≥25% in ABC-I score compared to the baseline, and a CGI-I score of much improved or very much improved) at Week 8 (or endpoint).The efficacy is assessed by response rate at Week 8 (or endpoint).
Time frame: Baseline and 8 weeks (or endpoint)
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