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irritability associated with autism spectrum disorder

Total Trials
1
Recruiting Now
1
Trial Phases
Phase 3

Autism spectrum disorder (ASD) trials target core symptoms (social communication, restricted/repetitive behaviors) as well as co-occurring conditions including anxiety, sleep disturbance, and gastrointestinal problems. The heterogeneity of ASD β€” driven by hundreds of genetic variants β€” has driven interest in genotype-stratified trials that enroll specific genetic subtypes (SHANK3, CHD8, FMR1).

Trials evaluate oxytocin nasal spray, vasopressin receptor modulators, mGluR5 antagonists in fragile X, bumetanide (GABA modulator), transcranial magnetic stimulation, and early intensive behavioral interventions. Biomarkers including EEG connectivity measures and eye-tracking are being validated as objective outcome measures.

Frequently Asked Questions — irritability associated with autism spectrum disorder Clinical Trials

How many clinical trials are currently recruiting for irritability associated with autism spectrum disorder?
ClinicalMetric currently tracks 1 actively recruiting clinical trials for irritability associated with autism spectrum disorder, sourced in real time from ClinicalTrials.gov. The total number of registered studies—including those not yet enrolling or in active follow-up—is 1. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for irritability associated with autism spectrum disorder?
irritability associated with autism spectrum disorder research spans Phase 3 (1 trial). Phase 1 studies evaluate safety and dosing in small groups, Phase 2 studies assess preliminary efficacy in 100–300 participants, and Phase 3 trials compare the new treatment against the standard of care in 300–3,000+ patients. Phase 4 post-approval studies monitor long-term outcomes in real-world populations.
How do I find out if I qualify for a irritability associated with autism spectrum disorder clinical trial?
Eligibility criteria for irritability associated with autism spectrum disorder trials vary by study and typically specify age range, disease stage or severity, prior treatment history, and specific diagnostic or laboratory parameters. Each listing on ClinicalMetric links to the full protocol on ClinicalTrials.gov, where inclusion and exclusion criteria are documented. Contact the sponsoring site's research coordinator directly to confirm your eligibility—your treating physician or specialist can also help identify the most appropriate trial based on your medical history and current treatment status.
Trial Phases
Phase 3
1
Top Sponsors
Intra-Cellular Therapies, Inc. 1 trial

Recruiting Clinical Trials

NCT06690398 Phase 3
Recruiting

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

Enrollment
174 pts
Location
United States
Sponsor
Intra-Cellular Therapies, Inc.
View Trial →
ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology