New schizophrenia drug tested in teens for safety

NCT ID NCT04779177

Completed Symptom relief Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the safety and tolerability of lumateperone, an antipsychotic drug, in 26 adolescents aged 13 to 17 with schizophrenia or schizoaffective disorder. Participants took either 28 mg or 42 mg of lumateperone by mouth. Researchers measured how the drug moves through the body and monitored side effects. The goal was to see if the drug is safe enough for further study in teenagers.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: lumateperone
What this could lead to: If successful, this could support the use of lumateperone as a treatment option for teenagers with schizophrenia or schizoaffective disorder.
What could go wrong: This is an early Phase 1 study with only 26 participants, so results may not apply to all teens. The main goal is safety, not yet proving the drug works for symptoms.

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Conditions

The condition(s) this trial relates to.

schizoaffective disorder schizophrenia

As listed by the trial registrant

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

PEDIATRIC SCHIZOPHRENIA

Contacts and locations

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Locations

Clinical Site

Hollywood, Florida, 33024, United States
Clinical Site

Atlanta, Georgia, 30331, United States
Clinical Site

Decatur, Georgia, 30030, United States

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