Autism
Conditions
Keywords
Autism, Aripiprazole, Abilify
Brief summary
* To evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder, as measured by change from baseline to endpoint on the irritability subscale of the aberrant behavior checklist (ABC-I). * To evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the treatment of serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder.
Detailed description
1\. Study design \- Multi-national, Multi-center, 52 weeks open label, single arm design
Interventions
DRUGAripiprazole
Sponsors
Korea Otsuka International Asia Arab
Yoo-Sook Joung
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 6 to 17 years of age. * Meeting the diagnostic criteria for autistic disorder specified by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), with a diagnosis corroborated by the Autism Diagnostic Interview-Revised (ADI-R) diagnostic instrument and demonstrated behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these. * Clinical Global Impressions (CGI) Severity subscale score ≥ 4 at screening and baseline. * Aberrant Behavior Checklist (ABC) Irritability subscale score ≥18 at screening and baseline. * Mental age ≥ 18 months. * Women of childbearing potential (WOCBP) have to use an adequate method of contraception * WOCBP must have had a negative serum or urine pregnancy test. * The patient and/or the designated guardian(s) or caregiver(s) who are able to comprehend and comply with the protocol requirements, in the opinion of the investigator and have consented to participate by signing an informed consent form.
Exclusion criteria
* Current diagnosis of bipolar disorder, schizophrenia, major depressive disorder, Rett's disorder, or Fragile-X syndrome. * History of neuroleptic malignant syndrome. * Significant risk of committing suicide based on history or routine psychiatric status examination. * History of seizure in the past 1 year. * History of severe head trauma or stroke * History or current evidence of any unstable medical conditions * Patient considered treatment resistant to neuroleptic medication * Patient considered treatment resistant to aripiprazole * Woman who is pregnant or breastfeeding * ECG: QTc \> 475 msec * Platelets ≤ 75,000/μL * Hemoglobin ≤ 9 g/dL * Neutrophils ≤ 1.0x10\^3/μL * Aspartate or alanine transaminase (AST or ALT) \> 3xULN * Serum creatinine ≥ 2 mg/dL * Patient weighed \< 15 kg * Patient who participated in any other clinical trial within 4 weeks * Patient determined to require the administration of the prohibited medications during the study period * Patient with other conditions determined by the investigator to be inappropriate for this clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| irritability subscale of the aberrant behavior checklist | Week 12 | Mean change from baseline to endpoint of Part 1 (week 12)in the caregiver-rated ABC Irritability (ABC-I) subscale score. ABC Scale will be completed by subject |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech | Week 1, 2, 4, 8, 12, 24, 36, 52 | ABC Scale will be completed by subject |
| Change of CGI-S, CGI-I from baseline | Week 1, 2, 4, 8, 12, 24, 36, 52 | CGI-S, CGI-I scale will be evaluated by investigator |
| Change of Adaptive Skills from baseline | week 12, 52 | Adaptive Skills Scale: Vineland Adaptive Behavior Scale (VABS) |
| Change of Parental stress from baseline | Weekk 12, 52 | Parental stress scale: Parenting Stress Index (PSI) |
| Change of Behavioral problems from baseline | Week 12, 52 | Behavioral problems scale: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | Week 1, 2, 4, 8, 12, 24, 36, 52 | Safety will be evaluated based on below inormaiton. * Laboratory test results (routine lab. and serum prolactin) * Vital signs (blood pressure, pulse, body temperature) * ECG * Weight gain * Extrapyramidal side effects (EPSEs) assessed by Simpson-Angus Rating Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS) |
Countries
Philippines, South Korea, Thailand
Contacts
Primary ContactHyemi Cheon
Outcome results
None listed