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RecruitingNCT06706674Updated Nov 3, 2026

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

A Phase 3 interventional study of Lumateperone high dose and Lumateperone low dose in Irritability Associated With Autism Spectrum Disorder, sponsored by Intra-Cellular Therapies, Inc.. Recruiting at 41 sites in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Intra-Cellular Therapies, Inc. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Updated Nov 3, 2026Site recruiting status changed2 sites added+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Irritability Associated With Autism Spectrum Disorder
03

In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's planned enrollment of 160 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Intra-Cellular Therapies, Inc. is the lead sponsor of 41 studies on the registry; 12 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.

First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson.

Browse Intra-Cellular Therapies, Inc. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.

  2. Able to provide consent as follows:

    1. The patient's LAR must provide written, .
    2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
  3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
  4. Meet , 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);
  5. ABC-I subscale score of >18 at Screening and Baseline;
  6. CGI-S score > 4 with respect to irritability associated with ASD at Screening and Baseline.

Exclusion criteria

Exclusion Criteria:

  1. Has a primary psychiatric diagnosis other than ASD. Exceptions include:

    1. 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.
    2. Mild and moderate intellectual disability based on Investigator judgment and criteria (severe and profound intellectual disability are excluded).
  2. History or current diagnosis of Rett syndrome or Fragile X syndrome;

  3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or

    1. 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;
    2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
    3. The patient is considered to be an imminent danger to themselves or others.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Lumateperone high dose

    Lumateperone 42 mg for patients ages 13-17 years old

    Drug: Lumateperone high dose

  • Experimental
    Lumateperone low dose

    Lumateperone 21 mg for patients ages 13-17 years old

    Drug: Lumateperone low dose

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugLumateperone high dose

    Lumateperone administered orally once daily

  • DrugLumateperone low dose

    Lumateperone administered orally once daily

  • DrugPlacebo

    Matching Placebo administered orally once daily

This study also gives Lumateperone. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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).

    Time frame: Week 6

07

Study locations

28 of 41 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Jun 2027, 30 months after the start.

Of 18 phase 3 interventional studies under Autism Spectrum Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 38. This study's planned 30 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2024
First posted
Nov 26, 2024
StartActual
Dec 6, 2024
Primary completionEst.
Jun 21, 2027
CompletionEst.
Jun 21, 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added, 1 site removed. 5 sites changed recruiting status (2 now recruiting, 2 now completed, …)
Show 5 sites
  • AP Medical Research · Miami, United StatesSuspended→Recruiting
  • NYU Child Study Center · New York, United StatesRecruiting→Suspended
  • Quest Therapeutics of Avon Lake · Avon Lake, United StatesRecruiting→Completed
  • North Texas Clinical Trials · Fort Worth, United StatesSuspended→Recruiting
  • Red Oak Psychiatry Associates · Houston, United StatesRecruiting→Completed
Show 2 added (2 United States)
  • Albert Einstein College Of Medicine · The Bronx, United States
  • Sooner Clinical Research · Norman, United States
Show 1 removed
  • Sooner Clinical Research · Oklahoma City, United States
across 2 updates, Sep 25, 2026 – Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    2 sites added, 1 site removed
    Show 2 added (2 United States)
    • Albert Einstein College Of Medicine · The Bronx, United States
    • Sooner Clinical Research · Norman, United States
    Show 1 removed
    • Sooner Clinical Research · Oklahoma City, United States
    + 1 other change: verification date
  2. Sep 25, 2026
    5 sites changed recruiting status (2 now recruiting, 2 now completed, …)
    Show 5 sites
    • AP Medical Research · Miami, United StatesSuspended→Recruiting
    • NYU Child Study Center · New York, United StatesRecruiting→Suspended
    • Quest Therapeutics of Avon Lake · Avon Lake, United StatesRecruiting→Completed
    • North Texas Clinical Trials · Fort Worth, United StatesSuspended→Recruiting
    • Red Oak Psychiatry Associates · Houston, United StatesRecruiting→Completed
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06706674
Lead sponsor
Intra-Cellular Therapies, Inc.
Responsible party
Sponsor
First posted
Nov 26, 2024
Start date
Dec 6, 2024
Primary completion
Jun 21, 2027 (estimated)
Completion
Jun 21, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Intra-Cellular Therapies, Inc. Clinical Trial
study director · Intra-Cellular Therapies, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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