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Antipsychotic

Lumateperone for Irritability in Autism

Phase 3
Recruiting
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights
Pivotal Trial

Summary

This trial will involve children between 5 and 17 years old with irritability associated with Autism Spectrum Disorder (ASD). The study will be conducted at multiple centers and will compare the effectiveness of a

Who is the study for?
This trial is for children aged 5 to 17 with irritability linked to Autism Spectrum Disorder (ASD), as defined by the DSM-5-TR and confirmed by K-SADS-PL. Specific eligibility details are not provided, but typically include a clear ASD diagnosis and stable health.
What is being tested?
The study tests Lumateperone at high and low doses against a placebo in pediatric patients. It's randomized, meaning participants are assigned randomly to one of these treatments, and double-blind, so neither the researchers nor participants know who gets what.
What are the potential side effects?
While specific side effects for Lumateperone in this trial aren't listed here, common ones may include sleepiness, changes in mood or behavior, stomach issues, weight gain or loss. Placebo has no active ingredients but can have perceived side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 13 and 17 years old.
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I have been diagnosed with ASD according to the DSM-5-TR criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aberrant Behavior Checklist - Irritability (ABC-I)
Secondary study objectives
Clinical Global Impression-Severity (CGI-S)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lumateperone low doseExperimental Treatment1 Intervention
Lumateperone 21 mg for patients ages 13-17 years old
Group II: Lumateperone high doseExperimental Treatment1 Intervention
Lumateperone 42 mg for patients ages 13-17 years old
Group III: PlaceboPlacebo Group1 Intervention
Placebo

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Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
39 Previous Clinical Trials
10,322 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
26 Patients Enrolled for Autism Spectrum Disorder
~116 spots leftby Mar 2027
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