Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior (ProjectV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University of California, Los Angeles
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
James McCracken, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01171937
First received: July 28, 2010
Last updated: January 11, 2016
Last verified: January 2016

July 28, 2010
January 11, 2016
September 2008
September 2016   (final data collection date for primary outcome measure)
Aberrant Behavior Checklist [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01171937 on ClinicalTrials.gov Archive Site
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Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior
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.
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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autism
  • Drug: Risperidone
    children get randomized to either placebo or active risperidone
    Other Name: Risperdal
  • Drug: Placebo
    Children get randomized to either placebo or risperidone
    Other Name: Inactive medicine
  • Active Comparator: Open-Label Risperidone
    Risperidone oral solution (1mg/mL) qd for 8 weeks.
    Intervention: Drug: Risperidone
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
December 2016
September 2016   (final data collection date for primary outcome measure)

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
Both
8 Years to 16 Years
No
Contact: Jenny Cowen 3108256170
United States
 
NCT01171937
07-06-033, P50HD055784
Yes
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James McCracken, University of California, Los Angeles
University of California, Los Angeles
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
University of California, Los Angeles
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP