Can a new pill ease depression without Add-Ons?

NCT ID NCT07747389

Not yet recruiting Disease control Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether lumateperone (Caplyta), taken alone, can reduce symptoms of major depressive disorder (MDD) compared to a placebo. About 585 adults with MDD will receive one of two doses of lumateperone or a placebo for six weeks, followed by a long-term extension where all participants can receive lumateperone. The main goal is to see if the medication improves depression severity, as measured by a standard rating scale.

What this could mean

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

Active substance: Lumateperone (Caplyta), an oral medication
What this could lead to: If successful, this could provide a new, effective monotherapy option for people with major depressive disorder, potentially improving daily functioning and quality of life.
What could go wrong: The trial is still in phase 3, and results may not confirm efficacy or safety. Side effects are possible, and the medication may not work for everyone.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for DEPRESSIVE DISORDER, MAJOR are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

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

DEPRESSIVE DISORDER, MAJOR

More trials for these conditions

Other studies related to the condition(s) this trial covers.