Study Name: Safety and Efficacy of Aripiprazole in the Long-Term Maintenance Treatment of Pediatric Patients with Irritability Associated with Autistic Disorder
PI: Linmarie Sikich, MD
Contact person: Lindsey Hazzard
The purpose of this study is to look to see if aripiprazole is safe and effective in children and adolescents 6 to 17 years of age who have symptoms of irritability associated with autistic disorder.
Subjects will be paid for each visit. Participants who park at the UNC parking garage will be provided with a parking voucher. Study medication and research related services will be free of charge.
Major inclusion criteria
- The subject is a male or female child or adolescent 6 to 17 years of age, inclusive at the time of the baseline visit.
- The subject and/or the designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator.
- The subject meets current DSM-IV-TR diagnostic criteria (see Appendix 1) for Autistic disorder and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. Diagnosis of autistic disorder will be confirmed by the Autism Diagnostic Interview-Revised (ADI-R).
- The subject has an Aberrant Behavior Checklist (ABC) Irritability subscale score ≥ 18 AND a Clinical Global Impressions Severity (CGI-S) score ≥ 4 at the Screening and Baseline Visits.
- The subject has a mental age of at least 24 months, as assessed by the investigator.
- Women of childbearing potential (WOCBP) and men who are sexually active must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. See Section 3.3.3 of the Protocol for the definition of WOCBP.
- Negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
Major exclusion criteria
- The subject is considered treatment resistant to neuroleptic medication, in the opinion of the investigator, based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each.
- The subject was previously treated with aripiprazole for at least 3 weeks in duration at an adequate daily dose and did not demonstrate a clinically meaningful response in the judgment of the investigator.
- The subject has a lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder.
- The subject is diagnosed with Pervasive Developmental Disorder-Not Otherwise Specified (NOS), Asperger’s Syndrome, Rett’s Syndrome, Childhood Disintegrative Disorder or Fragile X Syndrome.
- The subject has a history of neuroleptic malignant syndrome.
- The subject represents a significant risk of committing suicide based on history or routine psychiatric status examination.
- The subject has had a seizure within the past year.
- The subject has a history of severe head trauma or stroke.
- The subject has a history or current evidence of any unstable medical conditions (eg, history of congenital heart disease or arrhythmia, or cancer) that would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
- The subject has a history of a clinically significant low white blood cell count or a drug-induced leukopenia/neutropenia.
- The following laboratory test results, vital sign and ECG findings are exclusionary: i) QTc > 475 msec ii) Platelets ≤ 75,000/mm iii) Hemoglobin ≤ 9 g/dL iv) Neutrophils ≤ 1.0 x E3/mm (or equivalent) v) AST (SGOT) or ALT (SGPT) > 3 x upper limit of normal vi) Creatinine ≥ 2 mg/dL
- Subjects should be excluded if they have any other abnormal laboratory test result, vital sign result or ECG finding that in the investigator’s judgment is medically significant, in that it would impact the safety of the subject or the interpretation of the study results.
- The subject weighs less than 15 kg.
- The subject has taken an investigational agent within one month of the Screen Visit.
- Subjects who are likely to require prohibited concomitant therapy during the trial (refer to Prohibited and Restricted Therapies Section 3.4.1 and Table 3.4.1A in the Protocol)
- The subject has a known allergy or hypersensitivity to aripiprazole or other dihidrocarbostyrils (eg, carteolol, vesnarinone, and cilostazol).
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
- WOCBP using a prohibited contraceptive method (Note: No method of contraception is prohibited in this study). 19. Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Prisoners or subjects who are involuntarily incarcerated. b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- Subjects who plan to initiate or change or non-pharmacologic interventions during the course of the study. Subjects undergoing non-pharmacologic therapies (eg, psychotherapy, behavioral modification) must have started therapy at least 2 months prior to Visit 1 (Screen Visit) and must remain in a consistent treatment program for the duration of the study. Subjects cannot start or make changes to such programs during the study.
Site of study
UNC Neurosciences Hospital
Date enrollment closes
Study Related Resources