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Could a new pill calm Autism-Related irritability?

NCT ID NCT04895215

Symptom relief Sponsor: Vertero Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called AB-2004 to see if it can safely reduce irritability in people with autism spectrum disorder. 156 participants received either the drug or a placebo for 8 weeks. The main goal was to measure changes in irritability scores and check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

156 people

The number who actually took part.

Started

Aug 2021

Finished

Dec 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Clinically diagnosed, documented ASD (Diagnostic and Statistical Manual of Mental Disorders \[DSM-5\] criteria) * Aberrant Behavior Checklist - Irritability (ABC-I) score ≥18 at the Screening Period * Clinical Global Impression - Severity (CGI-S) scale score ≥4 at the Screening Period Key Exclusion Criteria: * Use of an oral, injected, or inhaled antibiotic within 30 days prior to screening. Prophylactic oral antibiotic use of no more than 1 dose will be permitted * Current use of an oral controlled or extended-release medication * Have a comorbid major psychiatric condition (eg, schizophrenia or bipolar disorder) at screening that in the opinion of the Investigator may interfere with the subject's ability to complete study procedures/comply with study requirements * Current use of antipsychotics (eg, aripiprazole or risperidone)

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Conditions

The condition(s) this trial relates to.

anxiety disorder autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder (ASD)

Contacts and locations

Locations

  • Baber Research

    Naperville, Illinois, 60563, United States

  • Brain Mind Centre

    Sydney, New South Wales, 2050, Australia

  • CNS Solutions

    Jacksonville, Florida, 32256, United States

  • CNS Solutions

    Orlando, Florida, 32801, United States

  • Children's Health Queensland Hospital

    South Brisbane, Queensland, 4101, Australia

  • Clinical Research of Southern Nevada

    Las Vegas, Nevada, 89128, United States

  • Cortica Marin

    San Rafael, California, 94903, United States

  • Cortica Westlake

    Westlake Village, California, 91361, United States

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303, United States

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112, United States

  • Monash Kids Research

    Clayton, Victoria, 3186, Australia

  • Murdoch Children's Research Institute

    Parkville, Victoria, 3052, Australia

  • Nathan S. Kline Institute for Psychiatric Research

    Orangeburg, New York, 10962, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Optimal Clinical Trials

    Grafton, Auckland, 1010, New Zealand

  • Relaro Medical Trials

    Dallas, Texas, 75243, United States

  • Southwestern Autism Research and Resource Center

    Phoenix, Arizona, 85006, United States

  • Spectrum Neuroscience and Treatment Institute

    New York, New York, 10021, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of Missouri, Thompson Center for Autism and Neurodevelopmental Disorders

    Columbia, Missouri, 65201, United States

  • University of South Florida

    Tampa, Florida, 33613, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

  • Westmead Children's Hospital

    Sydney, New South Wales, 2145, Australia

  • Yale University

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.