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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01171937
First received: July 28, 2010
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171937

Contacts
Contact: Jenny Cowen 3108256170

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Jenny Cowen    310-825-6170    jcowen@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
  More Information

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 August 28, 2014