New monthly shot for schizophrenia shows promise in early trial

NCT ID NCT06627413

Completed Disease control Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tested a long-acting injectable (LAI) form of the drug lumateperone in 52 adults with stable schizophrenia or schizoaffective disorder. Participants received a single injection of one of several LAI formulations, along with oral capsules, to see how the drug behaves in the body and whether it is safe. The goal is to develop a convenient monthly shot that could replace daily pills for managing symptoms.

What this could mean

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

Active substance: Lumateperone (long-acting injectable)
What this could lead to: If this works, it could lead to a once-monthly injection that helps control schizophrenia symptoms without needing daily pills.
What could go wrong: This is an early phase 1 study with only 52 people, so it's mainly checking safety and how the drug moves in the body. It's not yet proven to work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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.

SCHIZOPHRENIA OR SCHIZOAFFECTIVE

Contacts and locations

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Locations

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States
CenExeli Research LLC

Atlanta, Georgia, 30030, United States
Collaborative Neuroscience Research, LLC

Los Alamitos, California, 90720, United States
Hassman Research Institute, LLC.

Marlton, New Jersey, 08053, United States

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