Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior
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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.
Condition | Intervention | Phase |
---|---|---|
Autism |
Drug: Risperidone |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | RISPERIDONE TREATMENT IN CHILDREN WITH AUTISM SPECTRUM DISORDER AND HIGH LEVELS OF REPETITIVE BEHAVIOR |
- Aberrant Behavior Checklist [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Estimated Enrollment: | 52 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: Open-Label Risperidone |
Drug: Risperidone
Responders to Risperidone will get the medicine in the maintenance phase for 4 months on their best dose
|
Experimental: Double-Blind |
Drug: Risperidone
Children get randomized to either placebo or risperidone
|
Experimental: Sugar Pill |
Drug: Risperidone
children get randomized to either placebo or risperidone
|
Ages Eligible for Study: | 8 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or females of any race or ethnicity between the ages of 8 and 16 years,
- Body weight greater than 20 kg body weight
- 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.
- 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,
- 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.
- Ambulatory status (outpatient or day-treatment) at time of randomization
- Subject must demonstrate a mental age >18 months as determined by the Vineland Adaptive Behavior Scales.
- 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.
- 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:
- IQ below mental age of 18 months as measured by either the age-appropriate form of the Wechsler, the Revised Leiter, or the Mullen
- Females with a positive Beta HCG pregnancy test,
- 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)
- Evidence of hypersensitivity to risperidone (defined as allergic response [e.g., skin rash]) or potentially serious adverse effect (e.g., significant tachycardia)
- Past history of neuroleptic malignant syndrome.
- DSM-IV diagnosis of substance abuse.
- 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.
- The use of any other psychotropic medication
Contact: Jenny Cowen | 3108256170 |
United States, California | |
UCLA | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Jenny Cowen 310-825-6170 jcowen@mednet.ucla.edu |
No publications provided
Responsible Party: | James T. McCracken, M.D., UCLA |
ClinicalTrials.gov Identifier: | NCT01171937 History of Changes |
Other Study ID Numbers: | 07-06-033 |
Study First Received: | July 28, 2010 |
Last Updated: | July 28, 2010 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Los Angeles:
ages 8-16 Repetitive Behaviors |
Additional relevant MeSH terms:
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on October 17, 2012