Can a new pill ease depression without Add-Ons?
NCT ID NCT07747389
First seen Aug 05, 2026 · Last updated Sep 01, 2026 · Updated 3 times
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.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 585 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and where applicable at DB period baseline * Medically stable based on clinical laboratory tests performed at screening and where applicable at DB period baseline * Meets the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnostic criteria for recurrent or single episode MDD, without psychotic features, based upon clinical assessment and confirmed by Structured Clinical Interview for DSM-5 Axis I Disorders - Clinical Trials Version (SCID-CT) * Has moderate-to-severe depression as measured by a rater-administered MADRS total greater than or equal to (\>=) 26 score and corresponding to a CGI-S score of \>=4 at screening and DB baseline * Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score of \>=15 at screening and DB baseline Exclusion criteria: * The participant experiences a \>=25 percent (%) decrease in the MADRS total score between screening and DB baseline * The participant experiences a \>=25% decrease in the QIDS-SR-16 total score between screening and DB baseline * Has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening period, per the investigator's clinical judgment or based on the Columbia-Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behavior within the past 6 months prior to the start of the screening period * Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening * Has a history or evidence of clinically meaningful noncompliance with antidepressant therapy (ADT)s
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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