Autism Clinical Trial
Official title:
A Prospective Open-Label Trial of Aripiprazole Monotherapy in the Autism Spectrum Disorders (ASD)
The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from ASD over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.
Study Design: Fifteen patients with DSM-IV diagnoses of Autism, Asperger's Disorder or PDD
NOS will be enrolled in this 12-week open-label study. Parents of potential subjects will do
a preliminary phone screen, followed by a clinical evaluation by a psychiatrist for possible
inclusion in the study. Informed written consent and assent will be obtained from the
parents and subjects respectively once deemed competent and before the initiation of any
study procedures.
Clinical Evaluation will use the Autism Diagnostic Interview (ADI-R) and the Autism
Diagnostic Observation Schedule (ADOS) to establish a formal diagnosis.
Study Procedures Baseline Assessments: Many baseline measures for physical health will be
done at the screening visit and during the first weekly visit. These will include a clinical
interview, physical and neurological examination will be done during the screening period
and height, weight and vital signs, and a calculation of his/her Body Mass Index (BMI) will
be done during the screening period and during the first weekly visit. Laboratory measures
at baseline and study completion will include a complete metabolic panel (with liver
transaminases) and complete blood count with differential. Further measures will include a
fasting lipid profile, hemoglobin A1C, prolactin level and insulin levels, and fasting blood
sugar level (FBS). Serum albumin will be measured not only as a measure of nutritional
state, but also in accordance with the fact that aripiprazole is 99% protein-bound. An ECG
will be performed at the beginning and end of the study to monitor for possible cardiac
effects. These measures are aimed at monitoring side effects reported in the use of other
medications in this class. Urine pregnancy tests will be performed for each female subject
at the beginning and end of the study.
Outcome measures will include the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Brief
Psychiatric Rating Scale for children (BPRS-C), Clinical Global Impression - Severity
(CGI-S), Vineland Adaptive Behavior Scale (VABS) and the Atypical Children's Development
Scale (ACDS).
Baseline parameters for extrapyramidal side effects will be established using the Abnormal
Involuntary Movement Scale (AIMS), the Simpson Angus Extrapyramidal Side Effect Scale
(SAEPS) and the Barnes Akathisia Rating Scale. Baseline values for general side effects will
be compiled using the Monitoring of Side Effects System (MOSES).
Weekly visits: At all visits, patients will undergo a clinical interview, vital signs, and
weight measures. Custodial guardian(s) will provide collateral information. The weekly
"short" visits will occur at weeks 2, 4, 6, 8, 10 and 12. They will be about 45 minutes in
duration.
Ongoing outcome measures will be performed at visits 3, 5, 7, 9 and 11. The visits will be
about 1-1.5 hours in duration. The measures done will include those at the short visits, as
well as the Y-BOCS, BPRS, ABC and CGI-S. Side effects will be monitored using the AIMS,
SAEPS, Barnes Akathisia Scale and MOSES at these visits.
Termination Visit: The last visit (Visit 13 or earlier if patient drops out of the study)
will include the repetition of all measures at visit 1 (except the ADI-R) and will last
about 2 hours. All baseline laboratory measures will be repeated at this time.
Follow-Up Patient Care: After completion of the clinical trial, the patients will be
followed at the CHA Center for Child and Adolescent Development until they can be referred
back to their original psychiatric providers or to appropriate treatment providers in the
community.
Medication dosing: Aripiprazole will be started at 2.5mg or 5mg depending on clinical
impression and severity of especially aggression and agitation. At the weekly visits, the
dose will be adjusted in not more than 5mg increments according to clinical impression. The
lowest effective dose will be used, up to a maximum dose of 20mg.
Patients already taking psychotropic medications will be tapered off their medications
during the first 1-2 weeks of the study. The dose will be reduced to 67% of the initial dose
for 3 days and then to 33% of the initial dose for 3 days and then the medication(s) will be
discontinued. The subjects will remain off of on enrollment medications for 5 half lives and
then aripiprazole will be initiated. Anticonvulsant medications taken for seizure control
may be continued throughout the trial as long as the subject has been on a stable dose for
30 days prior to the study and has been seizure free for 6 months. These medication doses
will be held stable throughout the trial.
Adverse Events: Any serious adverse event leading to hospitalization will lead to study
discontinuation. Any event requiring concomitant medication(s) will also lead to
discontinuation. Adverse events will be reported to the IRB if there is an event requiring
medical attention, or scores 3 or higher on the MOSES scale. Also, failure to comply with
the study instructions will result in termination from the protocol.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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