Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 8 - 16 |
| Updated: | 5/4/2017 |
| Start Date: | September 2008 |
| End Date: | December 2016 |
Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels of Repetitive Behavior
The proposed study attempts to deepen our understanding of repetitive behaviors in autism
spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits
associated with risperidone treatment using functional MRI. This study is a substudy of a
larger center grant (IRB#07-03-066). Other studies also under this center grant, include:
IRB#03-02-085, IRB#95-01-028. All participants will have the option to enter another
sub-study, should they meet criteria. The proposed study will address this aim by mounting a
controlled trial of 52 children with Autism Spectrum Disorder. After screening assessment,
children will enter a three-part study. Phase 1 will be an 8-week, double-blind,
placebo-controlled flexible dose trial of risperidone. The extension phase is a 16-week
open-label maintenance phase for responders to risperidone or placebo. Non-responders to
placebo will be invited to enroll in the eight-week open-label study. 48 of the participants
will also undergo fMRI at Week 8 while on blinded treatment, as an optional sub-study. The
medication will be dispensed in a liquid suspension and the dose will range from 0.5 mg to
4.0mg.
spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits
associated with risperidone treatment using functional MRI. This study is a substudy of a
larger center grant (IRB#07-03-066). Other studies also under this center grant, include:
IRB#03-02-085, IRB#95-01-028. All participants will have the option to enter another
sub-study, should they meet criteria. The proposed study will address this aim by mounting a
controlled trial of 52 children with Autism Spectrum Disorder. After screening assessment,
children will enter a three-part study. Phase 1 will be an 8-week, double-blind,
placebo-controlled flexible dose trial of risperidone. The extension phase is a 16-week
open-label maintenance phase for responders to risperidone or placebo. Non-responders to
placebo will be invited to enroll in the eight-week open-label study. 48 of the participants
will also undergo fMRI at Week 8 while on blinded treatment, as an optional sub-study. The
medication will be dispensed in a liquid suspension and the dose will range from 0.5 mg to
4.0mg.
Inclusion Criteria:
1. Male or females of any race or ethnicity between the ages of 8 and 16 years,
2. Body weight greater than 20 kg body weight
3. DSM-IV diagnosis of Autistic Disorder, PDD, NOS, or Asperger's Disorder (established
by clinical assessment, corroborated by standard cutoff scores on the Autism
Diagnostic Interview and Autism Diagnostic Observation Schedule), as determined by
ADI-R administered by raters who are trained to research reliability, and confirmed
by an experienced and reliable clinician using DSM-IV-TR criteria.
4. Anticonvulsants used for the treatment of a seizure disorder will be permitted if the
dosage has been stable for 4 weeks and the patient is seizure free for at least 6
months,
5. Clinical Global Impression (CGI) Severity score of at least 4; and subjects must also
have a score greater than 7 on the first 3 items of the Compulsions Subscale of the
Revised PDD CY-BOCS.
6. Ambulatory status (outpatient or day-treatment) at time of randomization
7. Subject must demonstrate a mental age >18 months as determined by the Vineland
Adaptive Behavior Scales.
8. Subjects must be free neuroleptics two weeks prior to baseline. Subjects who are on
SSRIs or stimulants, must be on a stable dose for at least 4 weeks prior to baseline
visit.
9. Subjects and their parents (guardians) must be judged reliable for medication
compliance and must agree to keep appointments for study visits and tests as outlined
in the protocol.
Exclusion Criteria:
1. IQ below mental age of 18 months as measured by either the age-appropriate form of
the Wechsler, the Revised Leiter, or the Mullen
2. Females with a positive Beta HCG pregnancy test,
3. Evidence of a prior adequate trial with risperidone (defined as duration of four
weeks or more at a dose of at least 2 mg per day)
4. Evidence of hypersensitivity to risperidone (defined as allergic response [e.g., skin
rash]) or potentially serious adverse effect (e.g., significant tachycardia)
5. Past history of neuroleptic malignant syndrome.
6. DSM-IV diagnosis of substance abuse.
7. A significant medical condition such as heart disease, hypertension, liver or renal
failure, pulmonary disease, or unstable seizure disorder identified by history,
physical examination or laboratory tests.
8. The use of any other psychotropic medication
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