Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Conditions

• Autism Spectrum Disorder
• Bipolar Disorder
• Schizophrenia

Eligibility Criteria

Sex

ALL

Age

5 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Lumateperone — DRUG
  Lumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication

Study Details

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.

Key Dates

Start date

Jan 25, 2024

Status verified

Jul 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

500 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Lumateperone

Primary Outcome Measure

Incidence of Common Adverse Events [ Time Frame: Up to 6 months ]

Central Contacts

• ITI Clinical Trials
  646 440-9333
  [email protected]

Locations (47)

Find similar trials in Phoenix, AZ

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