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New pill aims to quiet Schizophrenia's worst symptoms

NCT ID NCT07038876

Symptom relief Sponsor: MapLight Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Updated 2 times

Summary

This study tests an experimental oral medication, ML-007C-MA, in 307 adults hospitalized with schizophrenia who are having a sudden worsening of psychosis. The goal is to see if the drug reduces symptoms like hallucinations and delusions better than a placebo. Participants take the drug or placebo daily while staying in the hospital, and doctors measure changes using standard symptom scales.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

307 people

The number who actually took part.

Started

Jun 2025

Finished

Jun 2026

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 64 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.

Key Inclusion Criteria: 1. Participant has a primary diagnosis of schizophrenia based on the DSM-5 criteria that is confirmed by semi-structured clinical interview (Mini International Neuropsychiatric Interview for DSM-5). 2. Participant may benefit from hospitalization or is currently hospitalized due to an acute exacerbation of schizophrenia symptoms, with exacerbation onset within 2 months of Screening. If the participant is already hospitalized for acute exacerbation of schizophrenia at Screening, they must have been inpatient for less than 2 weeks at the start of Screening. 3. At Screening and Baseline, schizophrenia symptoms are at least moderate in severity and persistent, as defined by the PANSS and CGI-S. 4. Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and adhere to protocol requirements. Key Exclusion Criteria: 1. Participant has any DSM-5 disorder, other than schizophrenia, within 12 months before Screening that is primarily responsible for the current symptoms or functional impairment. 2. Participant has any psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before Screening and/or current involuntary hospitalization or incarceration. 3. Participant received any antipsychotic medication or prohibited therapy within the Screening Period unless discontinued before Baseline. 4. Participant has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline. 5. Participant is at an elevated risk of suicidal behavior. 6. Participant has a known or likely allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients or has a known or likely severe allergic reaction (eg, anaphylactic reaction, angioedema) to any drug that could pose a risk to the participant in this study. 7. Participant has a DSM-5 diagnosis of moderate to severe substance use disorder (except tobacco or caffeine use disorder) within the 12 months before Screening (confirmed using Mini International Neuropsychiatric Interview). 8. Participation in a clinical research study involving the administration of an investigational or marketed drug, biological product, or device within 90 days of Baseline, or concomitant active participation in an investigational study involving no drug, biological product, or device. Participants who have previously participated in a study with ML-007 may not participate. 9. Participant is at elevated risk of violent or destructive behavior based on participant history and investigator judgment.

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Conditions

The condition(s) this trial relates to.

brain disorder central nervous system disorder nervous system disorder psychiatric disorder Psychotic Disorders schizophrenia

As listed by the trial registrant

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

Schizophrenia

Contacts and locations

Locations

  • Clinical Site

    Little Rock, Arkansas, 72211, United States

  • Clinical Site

    Bellflower, California, 90706, United States

  • Clinical Site

    Culver City, California, 90230, United States

  • Clinical Site

    Garden Grove, California, 92845, United States

  • Clinical Site

    Lemon Grove, California, 91945, United States

  • Clinical Site

    Los Angeles, California, 90015, United States

  • Clinical Site

    Montclair, California, 91763, United States

  • Clinical Site

    Orange, California, 92868, United States

  • Clinical Site

    Riverside, California, 92506, United States

  • Clinical Site

    San Diego, California, 92123, United States

  • Clinical Site

    Sherman Oaks, California, 91403, United States

  • Clinical Site

    Torrance, California, 90504, United States

  • Clinical Site

    Hollywood, Florida, 33024, United States

  • Clinical Site

    Miami Lakes, Florida, 33016, United States

  • Clinical Site

    West Palm Beach, Florida, 33407, United States

  • Clinical Site

    Atlanta, Georgia, 30331, United States

  • Clinical Site

    Decatur, Georgia, 30030, United States

  • Clinical Site

    Chicago, Illinois, 60640, United States

  • Clinical Site

    Marlton, New Jersey, 08053, United States

  • Clinical Site

    Staten Island, New York, 10314, United States

  • Clinical Site

    North Canton, Ohio, 44720, United States

  • Clinical Site

    Austin, Texas, 78754, United States

  • Clinical Site

    DeSoto, Texas, 75115, United States

  • Clinical Site

    Richardson, Texas, 75080, United States

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