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Can a new daily pill offer safer Long-Term control of schizophrenia?

NCT ID NCT07759869

Disease control Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This phase 3 trial is testing the long-term safety of an oral drug called HS-10380 in Chinese adults with schizophrenia. Over about a year, 500 participants will take the medication daily, with doses adjusted to an optimal level. The study tracks side effects, serious adverse events, and how well the drug controls symptoms. The goal is to see if HS-10380 can be a safe, ongoing treatment option for managing schizophrenia.

What this could mean

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

Active substance
HS-10380, an oral antipsychotic drug taken once daily
What this could lead to
If successful, this could support HS-10380 as a long-term treatment option for schizophrenia, potentially offering better safety or tolerability.
What could go wrong
This is an open-label study without a placebo, so results may be biased. Long-term safety and effectiveness are still uncertain, and side effects may emerge.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

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 65 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.

Inclusion Criteria: * Participant is aged 18-65 years, inclusive, at screening. * Body mass index must be ≥18.0 and ≤40.0 kg/m² at screening. * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria. * Willing and able to give informed consent/assent as per local requirements. * Participants are willing and able to discontinue all antipsychotic medications prior to the baseline visit, as determined by the investigator. Exclusion Criteria: * Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. * Judged by the investigator as having treatment-resistant schizophrenia. * Patients with risk of violent or destructive behavior, or suicidal risk. * History or presence of clinically significant disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. * Any surgical condition or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a risk to trial participants, such as history of gastrointestinal surgery (gastrectomy, gastroenterostomy, bowel resection, etc.), urinary tract obstruction, or dysuria. * History of severe allergic reactions. * Female patients who are pregnant, in puerperium, or lactating at screening or baseline. * History of drug abuse within 1 year prior to screening. * History of alcohol abuse within 6 months prior to screening. * Abnormal physical examination findings、vital signs or 12-lead electrocardiogram (ECG) at screening .

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Conditions

The condition(s) this trial relates to.

schizophrenia schizophrenia 1

As listed by the trial registrant

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

Schizophrenia 1 (disorder)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Peking University Sixth Hospital

    Beijing, Beijing Municipality, 100191, China

More trials for these conditions

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