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Schizophrenia treatment could go from daily pills to four shots a year

NCT ID NCT06276361

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase study tested a new long-acting injection of the antipsychotic drug risperidone that would only need to be given once every three months. Fifty-eight adults with stable schizophrenia received a single shot at different doses to measure how the drug moves through the body and to check for safety issues. The goal is to see if this quarterly shot could eventually offer a more convenient option for people who currently take daily risperidone pills.

What this could mean

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

Active substance
risperidone (quarterly injection)
What this could lead to
If successful, this could lead to a once-every-three-months injection for schizophrenia, reducing the need for daily pills.
What could go wrong
This is a very early Phase 1 study with only 58 participants, focused on safety and drug levels, not on how well it controls symptoms. The injection may not work as well as daily medication, and side effects are still being evaluated.

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

58 people

The number who actually took part.

Started

Sep 2023

Finished

Jul 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 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: * Capable of providing informed consent. * Male or female aged ≥ 18 years to \< 65 years with BMI ≥17.0 to ≤35.0 kg/m2 * Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria. * Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment * currently taking oral risperidone as maintenance therapy * Score of ≤ 4 (moderately ill at most) on the Clinical Global Impression - Severity of Illness (CGI-S) * If a sexually active female of childbearing potential, using a medically accepted method of birth control. Exclusion Criteria: * Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator could interfere with the interpretation of safety and PK evaluations * If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of study drug or is breastfeeding a child. * History of neuroleptic malignant syndrome and current or past history of clinically significant tardive dyskinesia. * The participant has a primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment * Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use. * In the investigator's opinion, at imminent risk of committing self-harm or harm to others. * Unwilling to discontinue any of the prohibited medications prior to the baseline visit or unable to safely washout such medication without significant destabilization or increased risk of self-harm (suicide). * Receipt study drug in another investigational study in the last 90 days. * Current participation in any other clinical trial.

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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.

Contacts and locations

Locations

  • Investigational Site

    Amman, Jordan

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