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New monthly shot for schizophrenia shows promise in early trial

NCT ID NCT06627413

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 4 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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

52 people

The number who actually took part.

Started

Aug 2024

Finished

Nov 2025

Lead sponsor

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

18 to 55 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: * Male or female patients between 18 and 55 years of age, inclusive; * Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5); * Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening; * Clinical Global Impression - Severity (CGI-S) score ≤ 3 at Screening and prior to dosing on Day 1; * Body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive at Screening, and a minimum body weight of 50 kg at Screening. Main Exclusion Criteria: * History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study; * Any suicidal ideation or wish to be dead within the past 6 months of Screening, any suicide attempt within the past 2 years prior to Screening, or any current concern for the patient's safety based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is a safety risk to him/herself or others; * Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables; * Has a QT interval corrected for heart rate using Fridericia formula \> 450 msec in males or \> 470 msec in females, or evidence of clinically significant bundle branch blocks on ECG at Screening.

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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

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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