Health Trials

Irritability Associated With Autism Spectrum Disorder

4

Review clinical trials related to Irritability Associated With Autism Spectrum Disorder. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Participants needed: 176
Trial details
Phase: Phase 3Age: 5-17Biological sex: AllType: InterventionalSponsor: Bristol-Myers SquibbUpdated: Jun 30, 2026Locations: 40
Eligibility criteria

Participants must have a confirmed diagnosis of ASD, as defined by the Diagnosti... [+1]

Participants must not have a current primary DSM-5 diagnosis of bipolar disorder... [+4]

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Status: Not yet recruiting

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Participants needed: 176
Trial details
Phase: Phase 3Age: 5-17Biological sex: AllType: InterventionalSponsor: Bristol-Myers SquibbUpdated: Jun 30, 2026Locations: 54
Eligibility criteria

Participants must have a confirmed diagnosis of ASD, as defined by the Diagnosti... [+1]

Participants must not have a current primary DSM-5 diagnosis of bipolar disorder... [+4]

Read more
Status: Recruiting

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

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).

Participants needed: 174
Trial details
Phase: Phase 3Age: 5-17Biological sex: AllType: InterventionalSponsor: Intra-Cellular Therapies, Inc.Updated: Jul 8, 2025Locations: 39
Eligibility criteria

All patients must have a legally authorized representative LAR (eg, parent or le... [+6]

Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medicati... [+6]

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Status: Recruiting

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

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).

Participants needed: 174
Trial details
Phase: Phase 3Age: 5-17Biological sex: AllType: InterventionalSponsor: Intra-Cellular Therapies, Inc.Updated: Jul 4, 2025Locations: 37
Eligibility criteria

All patients must have a legally authorized representative LAR (eg, parent or le... [+6]

Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medicati... [+6]

Read more