Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Lindsay DeVane, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01333072
First received: September 20, 2010
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will provide evidence-based guidance in the selection and monitoring of drug treatment of autism. BAART involves 3 academic centers across South Carolina. Although the FDA has approved use of the antipsychotic drug risperidone for irritability associated with autistic disorder, a moderate response rate in pivotal clinical trials and concerns over tolerability and weight gain can force clinicians to select alternative drug treatments for which evidence-based support is sparse.


Condition Intervention
Autistic Disorder
Drug: Aripiprazole
Drug: Risperidone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Biomarkers in Autism of Aripiprazole and Risperidone Treatment

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • To identify phenotypic and genetic traits that predict response to aripiprazole and risperidone in Autistic Disorder [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Multi-center, blinded clinical trial to evaluate biomarkers as predictors of efficacy and safety in children with autistic disorder to risperidone, an atypical antipsychotic drug and aripiprazole, an antipsychotic having a unique clinical and receptor-binding profile.


Estimated Enrollment: 250
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Risperidone
Atypical antipsychotic
Drug: Risperidone
Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day (McCracken et al 2002).
Other Name: Risperdal
Active Comparator: Aripiprazole
Atypical antipsychotic
Drug: Aripiprazole
The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks.
Other Name: Abilify

Detailed Description:

The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will provide evidence-based guidance in the selection and monitoring of drug treatment of autism. BAART involves 3 academic centers across South Carolina with expertise in phenotyping patients with autistic spectrum disorders, assessing patient response in clinical trials, and expertise in pharmacogenomic research. Although the FDA has approved use of the antipsychotic drugs risperidone and aripiprazole for irritability associated with autistic disorder, a moderate response rate in pivotal clinical trials and concerns over tolerability and weight gain can force clinicians to select alternative drug treatments for which evidence-based support is sparse. BAART will assess predictors of efficacy, tolerability, and safety in 200 children 6-17 years old with autistic disorder (AD) during a double-blind, randomized 10 week treatment period with either risperidone or aripiprazole. Responders who complete the study may continue with medication treatment for three months. Factors considered will include 1) psychiatric history; 2) symptom response; 3) psychosocial support; 4) measures of tolerability; 5) serum prolactin and brain-derived neurotrophic factor concentration; and 5) a variety of single nucleotide polymorphisms related to target genes for drug disposition and transport, response, and tolerability. The BAART project will result in evidence-based guidelines for selection and monitoring of drug treatment of children and adolescents with AD.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Aged 6 to 17 years and weight of at least 15 kg
  • Meet DSM-IV criteria for of AD, established by chart review, clinical judgment and the Autism Diagnostic Interview- Revised (ADI-R) criteria
  • Clinical Global Impressions Severity (CGI-S) score of >4 (moderately ill)
  • ABC Irritability subscale score of >18
  • Mental age of at least 18 months
  • If female and sexually active, must agree to an acceptable method of birth control during the trial
  • Medication free or adequate washout period (2-4 weeks prior to enrollment) of psychoactive drugs (anticonvulsants permitted for seizure management if dosage is stable for 4 weeks)
  • Parent/guardian able to read and provide informed consent.

Exclusion Criteria

  • Psychiatric disorder that is effectively managed by psychoactive medication (e.g. ADHD, MDD)
  • Prior diagnosis or evidence of genetic or other disorder that may interfere with assessments (e.g. Fragile X syndrome, Fetal alcohol syndrome, history of very low birth weight) assessed by personal and family history, dysmorphology, and clinical judgment.
  • Prior use of risperidone or aripiprazole for more than 2 weeks
  • Seizure during the past 6 months
  • History or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments during the trial including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, hematologic or immunologic disease as determined by the clinical judgment of the investigator
  • Current suicidal or homicidal risk
  • Positive urine pregnancy test at baseline
  • Dependent on other substances, with the exception of nicotine or caffeine
  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: NCT01333072

Contacts
Contact: Stacey Wilson 843-792-0384 wilstac@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: C. Lindsay DeVane, PharmD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: C. Lindsay DeVane, Pharm.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Lindsay DeVane, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01333072     History of Changes
Other Study ID Numbers: R01HD062550-01A1
Study First Received: September 20, 2010
Last Updated: May 1, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Autistic Disorder

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Aripiprazole
Risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 29, 2014