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.
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