Irritability Associated With Autism Spectrum DisorderPhase 3NCT06706674
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
A Phase 3 study testing Lumateperone high dose and Lumateperone low dose in people with Irritability Associated With Autism Spectrum Disorder, run by Intra-Cellular Therapies, Inc. at 40 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Irritability Associated With Autism Spectrum Disorder
- What is being tested?
- Lumateperone high dose and Lumateperone low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 40 sitesUnited States
- Study dates
- 6 Dec 2024to 21 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
- Able to provide consent as follows:
- The patient's LAR must provide written, informed consent.
- When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
- Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
- ABC-I subscale score of >18 at Screening and Baseline;
- CGI-S score > 4 with respect to irritability associated with ASD at Screening and Baseline.
Who cannot join
- Has a primary psychiatric diagnosis other than ASD. Exceptions include:
- Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
- Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
- History or current diagnosis of Rett syndrome or Fragile X syndrome;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
- At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
- The patient is considered to be an imminent danger to themselves or others.
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
40 sites in 1 country
United States40 sites, 27 recruiting
- Completed
Advanced Discovery Research
Atlanta, Georgia, 30318
- Completed
BioBehavioral Research of Austin PC
Austin, Texas, 78759
- Completed
Quest Therapeutics of Avon Lake
Avon Lake, Ohio, 44012
- Recruiting
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
EmVenio Research at Chicago
Chicago, Illinois, 60622
- Recruiting
Texas Research Group
Coppell, Texas, 75019
- Completed
Future Search Trials of Dallas
Dallas, Texas, 75251
- Recruiting
Core Clinical Research
Everett, Washington, 98201
- Recruiting
North Texas Clinical Trials
Fort Worth, Texas, 76104
- Recruiting
United Research Institute
Hialeah, Florida, 33012
- Suspended
Advanced Research Institute of Miami
Homestead, Florida, 33033
- Completed
Red Oak Psychiatry Associates
Houston, Texas, 77090
- Completed
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
- Completed
Salveo Integrative Health Inc
Lawrenceville, Georgia, 30046
- Recruiting
Alivation Research LLC
Lincoln, Nebraska, 68526
- Recruiting
Pillar Clinical Research, LLC
Little Rock, Arkansas, 72204
- Suspended
Vital Care Research
Miami, Florida, 33122
- Recruiting
Care Research Center Inc
Miami, Florida, 33130
- Recruiting
Blue Medical Research
Miami, Florida, 33144
- Recruiting
AP Medical Research
Miami, Florida, 33165
- Completed
GTL Medical and Research Group
Miami, Florida, 33173
- Recruiting
New Med Research Inc
Miami Gardens, Florida, 33056
- Suspended
Riveldi Biomedical Research
Miami Lakes, Florida, 33014
- Recruiting
Baber Research Group
Naperville, Illinois, 60563
- Recruiting
Yale University School Of Medicine
New Haven, Connecticut, 06519
- Suspended
NYU Child Study Center
New York, New York, 10016
- Recruiting
SP Research, PLLC (dba Rivus Wellness & Research Institute)
Oklahoma City, Oklahoma, 73112
- Recruiting
Sooner Clinical Research
Oklahoma City, Oklahoma, 73116
- Recruiting
Nathan Kline Institute
Orangeburg, New York, 10962
- Recruiting
APG Research LLC
Orlando, Florida, 32803
- Completed
Orlando Psychiatric Associates
Orlando, Florida, 32809
- Recruiting
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23220
- Recruiting
University Of California - Davis
Sacramento, California, 95817
- Recruiting
California Neuroscience Research
Sherman Oaks, California, 91403
- Recruiting
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, 71101
- Recruiting
University of South Florida Rothman Center of Neuropsychiatry
St. Petersburg, Florida, 33701
- Recruiting
Richmond Behavioral Associates
Staten Island, New York, 10314
- Recruiting
Advantage Clinical Trials
The Bronx, New York, 10467
About this study
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
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
Read the detailed description
The study will be conducted in 3 phases:
- Screening Period (up to 14 days) during which patient eligibility will be assessed.
- Double-blind Treatment Period (DBTP) (6 weeks) during which all patients will be randomized in a 1:1:1 ratio to receive either lumateperone high dose, lumateperone low dose, or placebo as a once daily dose.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately 1 week after the last dose of study drug.
- Being tested
- Lumateperone high dose, Lumateperone low dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumateperone high doseDrug
Lumateperone administered orally once daily
Lumateperone low doseDrug
Lumateperone administered orally once daily
PlaceboDrug
Matching Placebo administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone high dose | Experimental | Lumateperone 42 mg for patients ages 13-17 years old Receives: Drug: Lumateperone high dose |
| Lumateperone low dose | Experimental | Lumateperone 21 mg for patients ages 13-17 years old Receives: Drug: Lumateperone low dose |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist - Irritability (ABC-I)
The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe).
Measured: Week 6
Secondary outcomes (1)
Clinical Global Impression-Severity (CGI-S)
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start6 Dec 2024
- Primary completion21 Jun 2027 (estimated)
- Study completion21 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritability Associated With Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Intra-Cellular Therapies, Inc. Clinical Trial, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706674
- Sponsor's protocol ID
- ITI-007-602
- Other IDs
- ITI-007-602
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06706674
- Acronym / sponsor ID
- ITI-007-602
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 21 Jun 2027 (estimated)
- Study completion
- 21 Jun 2027 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
Detailed description
The study will be conducted in 3 phases:
- Screening Period (up to 14 days) during which patient eligibility will be assessed.
- Double-blind Treatment Period (DBTP) (6 weeks) during which all patients will be randomized in a 1:1:1 ratio to receive either lumateperone high dose, lumateperone low dose, or placebo as a once daily dose.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately 1 week after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumateperone high dose | Experimental | Drug: Lumateperone high doseLumateperone 42 mg for patients ages 13-17 years old |
| Lumateperone low dose | Experimental | Drug: Lumateperone low doseLumateperone 21 mg for patients ages 13-17 years old |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
- Able to provide consent as follows:
- Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
- ABC-I subscale score of >18 at Screening and Baseline;
Key exclusion criteria (8 listed)
- Has a primary psychiatric diagnosis other than ASD. Exceptions include:
- History or current diagnosis of Rett syndrome or Fragile X syndrome;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumateperone high doseLumateperone administered orally once daily | Drug | Lumateperone high dose |
| Lumateperone low doseLumateperone administered orally once daily | Drug | Lumateperone low dose |
| PlaceboMatching Placebo administered orally once daily | Drug | Placebo |
Primary outcome
Aberrant Behavior Checklist - Irritability (ABC-I)
Time frame: Week 6
The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe).
1 secondary outcome
Clinical Global Impression-Severity (CGI-S)
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Intra-Cellular Therapies, Inc. Clinical Trial study director
Intra-Cellular Therapies, Inc.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumateperone high dose and Lumateperone low dose in people with Irritability Associated With Autism Spectrum Disorder, run by Intra-Cellular Therapies, Inc. at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist - Irritability (ABC-I) (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.