Autism Trial with Lurasidone

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  • Study director: Robert Hendren, DO
  • Sponsor: Sunovion
  • Recruiting?: No
  • Official study title: A 6-Week Randomized, Parallel, Double-Blind, Placebo Controlled, Fixed-Dose, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects with Irritability Associated with Autistic Disorder
  • identifier: NCT01911442
  • Conditions studied: Autistic disorder
  • Intervention: Lurasidone
  • Phase: Phase III
  • Purpose: To evaluate the efficacy and safety of two fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.


  • Inclusion criteria:
    • Male or female subjects 6–17 years old
    • Child has a diagnosis of autistic disorder
    • Child has CGI-S score of at least 4 and an ABC Irritability subscale score of at least 18 at the screening and baseline visits
    • Child is able to swallow the size and number of study drug tablets
    • Child is able to adhere to protocol-specified meal requirements during dosing
    • Have a stable living arrangement for at least 3 months prior to screening
    • Non-pharmacologic therapy (e.g., behavior modification) must be stable for at least 4 weeks before screening and consistent throughout the study
    • English must be primary language of child
  • Exclusion criteria:
    • Subjects with profound intellectual disability
    • Current diagnosis of bipolar disorder, psychosis, schizophrenia or major depression, or childhood disintegrative disorder
    • Confirmed genetic disorders with cognitive and behavioral disturbances are also exclusionary
    • Evidence of any chronic organic disease of the CNS such as Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders (past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary)
    • If the subject has a history of seizures, the subjects must not currently be taking any antiepileptic drugs (AEDs) and be seizure-free for at least 6 months
    • A history or presence of abnormal ECG
    • Known history or presence of clinically significant intolerance to any antipsychotic medications
    • Presence or history (within the last year) of a medical or surgical condition (e.g., gastrointestinal disease)
    • Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS) or history of Hepatitis B or C
    • Received depot neuroleptics unless the last injection was at least 1 month prior to screening
    • Subject has received treatment with antidepressants within 3 days, fluoxetine hydrochloride at any time within 21 days, an MAO inhibitor within 21 days of randomization or clozapine within 120 days of randomization. Depot neuroleptics must be discontinued at least one treatment cycle prior to randomization.
    • Use of any antipsychotic medication within 3 days prior to randomization
    • Significant risk of committing suicide
    • Clinically relevant history of drug hypersensitivity to lurasidone

What is involved?

  • Testing: Behavioral assessments, cognitive testing, parent questionnaires, physical examinations, EKGs, blood and urine specimen collection, and vital signs
  • Frequency of visits: The study may last up to 10 weeks and will involve 10 visits to UCSF, each visit about one week apart
  • Materials needed prior to evaluation: Past medical records
  • Costs: No costs will be charged for any of the study procedures. We will provide $40 for each visit, to help with costs of transportation and parking.

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