Lurasidone Pediatric Autism Study
Public ClinicalTrials.gov record NCT01911442. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 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.
Study identification
- NCT ID
- NCT01911442
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2013 (Type not available)
- Primary completion
- Nov 2014 (Actual)
- Completion
- Nov 2014 (Actual)
- Last update posted
- Feb 25, 2016
2013 – 2014
United States locations
- U.S. sites
- 41
- U.S. states
- 24
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | — |
| Southwest Autism Research & Resource Center | Phoenix | Arizona | 85006 | — |
| Newport Beach Clinical Research Associates | Newport Beach | California | 92663 | — |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | — |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | — |
| Sarkis Clinical Trials - Parent | Gainesville | Florida | 32607 | — |
| Palm Springs Research Institute Inc | Hialeah | Florida | 33012 | — |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | — |
| Medical Research Group of Central Florida | Sanford | Florida | 32771 | — |
| University of South Florida | St. Petersburg | Florida | 33701 | — |
| University of South Florida | Tampa | Florida | 33613-4706 | — |
| Institute for Behavioral Medicine, LLC | Smyrna | Georgia | 30080 | — |
| Capstone Clinical Research, Inc. | Libertyville | Illinois | 60048 | — |
| Baber Research Group | Naperville | Illinois | 60563 | — |
| University of Kentucky | Lexington | Kentucky | 40509 | — |
| Lake Charles Clinical Trials, LLC | Lake Charles | Louisiana | 70629 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21287 | — |
| NeuroScientific Insights | Rockville | Maryland | 20852 | — |
| Neurobehaviorial Medicine Group, PLLC | Bloomfield Hills | Michigan | 48302 | — |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| Childrens Specialized Hospital | Toms River | New Jersey | 08755 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| Montefiore Medical Center PRIME | The Bronx | New York | 10467 | — |
| Chapel Hill Neurology | Chapel Hill | North Carolina | 27517 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University Nisonger Center | Columbus | Ohio | 43210 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | — |
| Cyn3rgy Research & Development | Gresham | Oregon | 97030 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| Segal Institute for Clinical Research | Charleston | South Carolina | 29407 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Family Psychiatry of The Woodlands, P.A. | The Woodlands | Texas | 77381 | — |
| Ericksen Research & Development, LLC | Clinton | Utah | 84015 | — |
| CRI Lifetree | Salt Lake City | Utah | 84106 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Neuroscience, Inc. | Herndon | Virginia | 20170 | — |
| Carilion Clinic | Roanake | Virginia | 24014 | — |
| Pacific Institute of Medical Sciences | Bothell | Washington | 98011 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01911442, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 25, 2016 · Synced Nov 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01911442 live on ClinicalTrials.gov.