Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
Public ClinicalTrials.gov record NCT06706674. 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 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age
Study identification
- NCT ID
- NCT06706674
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Industry
- Enrollment
- 160 participants
Conditions and interventions
Interventions
- Lumateperone high dose Drug
- Lumateperone low dose Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 5 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
- Dec 5, 2024
- Primary completion
- Jun 20, 2027
- Completion
- Jun 20, 2027
- Last update posted
- Jul 6, 2026
2024 – 2027
United States locations
- U.S. sites
- 38
- U.S. states
- 17
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pillar Clinical Research, LLC | Little Rock | Arkansas | 72204 | Recruiting |
| University Of California - Davis | Sacramento | California | 95817 | Recruiting |
| California Neuroscience Research | Sherman Oaks | California | 91403 | Recruiting |
| Yale University School Of Medicine | New Haven | Connecticut | 06519 | Recruiting |
| United Research Institute | Hialeah | Florida | 33012 | Recruiting |
| Advanced Research Institute of Miami | Homestead | Florida | 33033 | Suspended |
| Vital Care Research | Miami | Florida | 33122 | Suspended |
| Care Research Center Inc | Miami | Florida | 33130 | Recruiting |
| Blue Medical Research | Miami | Florida | 33144 | Recruiting |
| AP Medical Research | Miami | Florida | 33165 | Suspended |
| New Med Research Inc | Miami Gardens | Florida | 33056 | Recruiting |
| Riveldi Biomedical Research | Miami Lakes | Florida | 33014 | Suspended |
| APG Research LLC | Orlando | Florida | 32803 | Recruiting |
| Orlando Psychiatric Associates | Orlando | Florida | 32809 | Completed |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | Recruiting |
| University of South Florida Rothman Center of Neuropsychiatry | St. Petersburg | Florida | 33701 | Recruiting |
| Advanced Discovery Research | Atlanta | Georgia | 30318 | Recruiting |
| Salveo Integrative Health Inc | Lawrenceville | Georgia | 30046 | Recruiting |
| EmVenio Research at Chicago | Chicago | Illinois | 60622 | Recruiting |
| Baber Research Group | Naperville | Illinois | 60563 | Recruiting |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | Completed |
| Louisiana State University Health Sciences Center Shreveport | Shreveport | Louisiana | 71101 | Recruiting |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | Recruiting |
| Alivation Research LLC | Lincoln | Nebraska | 68526 | Recruiting |
| NYU Child Study Center | New York | New York | 10016 | Recruiting |
| Nathan Kline Institute | Orangeburg | New York | 10962 | Recruiting |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | Recruiting |
| Advantage Clinical Trials | The Bronx | New York | 10467 | Recruiting |
| Quest Therapeutics of Avon Lake | Avon Lake | Ohio | 44012 | Recruiting |
| SP Research, PLLC (dba Rivus Wellness & Research Institute) | Oklahoma City | Oklahoma | 73112 | Recruiting |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73116 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| BioBehavioral Research of Austin PC | Austin | Texas | 78759 | Recruiting |
| Future Search Trials of Dallas | Dallas | Texas | 75251 | Completed |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | Suspended |
| Red Oak Psychiatry Associates | Houston | Texas | 77090 | Recruiting |
| Virginia Commonwealth University | Richmond | Virginia | 23220 | Recruiting |
| Core Clinical Research | Everett | Washington | 98201 | Recruiting |
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 NCT06706674, 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 Jul 6, 2026 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06706674 live on ClinicalTrials.gov.