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

Recruiting Phase 3 Interventional Study
Schizophrenia Bipolar Disorder Autism Spectrum Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
5 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Intra-Cellular Therapies, Inc. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Able to provide consent as follows: * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent; * The patient must provide written assent to study enrollment; * Male or female patients aged 13 to 17 years (inclu…
Contacts

ITI Clinical Trials

646 440-9333

ITCIClinicalTrials@itci-inc.com

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