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Monthly shot may beat daily pills for schizophrenia

NCT ID NCT07075237

Disease control Sponsor: Jiangsu Province Nanjing Brain Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether switching from daily oral antipsychotics to a monthly injection of paliperidone palmitate helps people with schizophrenia control symptoms and improve social function. Researchers will enroll 120 adults aged 18-65 who are stable on oral meds. Participants receive injections for 6 months, and the team tracks symptom severity and daily functioning.

What this could mean

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

Active substance
paliperidone palmitate injection
What this could lead to
If successful, this could show that switching to a monthly injection helps people with schizophrenia maintain symptom control and improve social functioning better than daily pills.
What could go wrong
This is a small, early-stage Phase 4 study with only 120 participants. Results may not apply to everyone, and injections can cause side effects like injection-site reactions or movement disorders.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Outpatients or inpatients meeting DSM-5 diagnostic criteria forschizophrenia; 2. Aged 18-65 years (inclusive), regardless of gender; 3. Currently receiving first- or second-generation oral antipsychotics (excluding clozapine) with stable condition as assessed by the investigator, and PANSS total score ≤80 at screening and baseline; 4. Signed informed consent by the patient and/or guardian; Exclusion Criteria: 1. Comorbid psychiatric diagnoses other than schizophrenia; 2. Severe physical diseases, intellectual disability, organic brain disorders, or mental disorders due to physical illnesses; 3. QTc interval \>450 ms (male) or \>460 ms (female); 4. History of psychoactive substance abuse (excluding tobacco) within the past 12 months, or significant suicidal/violent tendencies; 5. Current or history of tardive dyskinesia (TD), neuroleptic malignant syndrome (NMS), or severe extrapyramidal symptoms (EPS); 6. Treatment-resistant schizophrenia (failure of ≥2 adequate antipsychotic regimens of different compounds); 7. Hypersensitivity or inefficacy to risperidone or paliperidone; 8. Pregnancy, lactation, planned pregnancy, or failure to use effective contraception during the study; 9\. Other conditions deemed unsuitable by the investigator. \|

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Conditions

The condition(s) this trial relates to.

schizophrenia Social Adjustment

As listed by the trial registrant

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

Schizophrenia

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

  • Nanjing Brain Hospital

    Nanjing, Jiangsu, 210024, China

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