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New study tests Extended-Release paliperidone for schizophrenia in bangladesh

NCT ID NCT07153835

Disease control Sponsor: Sher-E-Bangla Medical College 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study will test the safety and effectiveness of paliperidone extended-release tablets in 505 adults with schizophrenia in Bangladesh. Participants will take the medication once daily for 12 weeks, with doses adjusted as needed. Researchers will measure changes in symptoms using standard rating scales and track side effects.

What this could mean

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

Active substance
paliperidone extended-release (oral tablet)
What this could lead to
If successful, this could confirm that paliperidone is a safe and effective option for managing schizophrenia symptoms in a Bangladeshi population.
What could go wrong
This is an early-phase, single-arm, open-label study with no placebo or comparison group, so results may be less reliable. Side effects like drowsiness, weight gain, or movement problems are possible.

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 505 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jul 2026

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 60 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: * Adults aged 18-60 years * Diagnosed with schizophrenia according to DSM-5 criteria * At least 3 months since the initial diagnosis of schizophrenia * Either antipsychotic-naïve or previously treated with one antipsychotic but requiring a change due to non-response, poor response, or intolerable side effects. (If previously treated, a washout period of 7 days before study medication initiation) * PANSS (Positive and Negative Syndrome Scale) total score ≥70 * Clinically stable for at least 2 weeks before enrollment Exclusion Criteria: * History of being diagnosed with treatment-resistant schizophrenia * Comorbid severe medical or neurological conditions * Pregnant or lactating women * Previous known hypersensitivity to paliperidone or risperidone * Use of long-acting injectable antipsychotics within the last 3 months * Current diagnosis of substance related disorder or substance misuse in the previous month

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Conditions

The condition(s) this trial relates to.

schizophrenia

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

  • Sher-E-Bangla Medical College Hospital

    Barishal, 8200, Bangladesh

More trials for these conditions

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