Could a quick switch to stronger meds change schizophrenia care?

NCT ID NCT05958875

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at whether giving a more powerful medication sooner can help people with schizophrenia who did not get better on their first treatment. About 418 adults will either receive the usual second-line treatment or an early intensified approach. The goal is to see if this strategy reduces symptoms and prevents hospital stays.

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 418 people

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

Started

Aug 2024

Expected to finish

Jun 2028

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 70 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. In- or out patients, at least 18 years of age up until 70. 2. Being willing and able to provide written informed consent. Having a legal guardian to cosign is allowed. Informed consent will be signed at visit 1, before any study procedure. 3. Female subjects of child bearing potential must use effective contraception during the trial as per the requirements of the applicable SmPCs and should have a negative pregnancy test at visit 1 or 2 (before randomisation; section 8.2). 4. Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder, according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). 5. Subject experiences a treatment failure due to lack of efficacy in the current episode, as confirmed by a CGI-I ≥3; preferably this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within an effective dose range as specified in the Summary of Product Characteristics (SmPCs). However, other lines of treatment are accepted as well. 6. Subject and clinician intend to change pharmacotherapeutic treatment. 7. A minimum symptom severity threshold needs to be present (moderate level; see below) and subject needs to experience functional impairment. * The minimum symptom severity threshold is at least 2 PANSS positive or negative items with a score of 4, or at least one PANSS positive or negative item with a score of 5. * Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS). Exclusion criteria: 1. Being pregnant or breastfeeding. 2. Subject has used clozapine in the past. 3. Subject has a known intolerance to clozapine or to all TAU medication options. 4. Meeting any of the contraindications of clozapine or to all TAU medication options, as specified within the applicable SmPC. 5. Subject has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit 1. 6. Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the trial, or may influence the result of the trial, or the subject's ability to participate in the trial. 7. Subjects with active suicidal ideation with some intent to act, without specific plan ("Yes" to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS)) or active suicidal ideation with specific plan and intent ("Yes" to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the subject to participate in the study 8. Subject meets criteria for current substance use disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). Nicotine dependency is allowed, as well as mild and moderate alcohol and/or cannabis use disorder (as defined by MINI v7.0.2). Severe alcohol and/or cannabis use disorder are not allowed. 9. Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 10. Subjects who meet the modified Andreasen criteria for remission. 11. Subjects that have any clinically significant abnormal values on the local laboratory test (especially ANC/WBC and liver values), electrocardiogram (ECG) or physician examinations. 12. Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance

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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.

How to take part

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

  1. The places running it

    13 sites in 5 countries. 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

  • Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"

    RECRUITING

    Turin, Italy

  • Bezirkskliniken Schwaben, Bezirkskrankenhaus Augsburg

    NOT_YET_RECRUITING

    Augsburg, 86156, Germany

  • Fundació Clínic per a la Recerca Biomèdica

    RECRUITING

    Barcelona, Spain

  • King's College London, Psychiatry & Cognitive Neuroscience

    RECRUITING

    London, SE5 8AF, United Kingdom

  • Klinik für Psychiatrie und Psychotherapie der Universitätsmedizin Mainz

    RECRUITING

    Mainz, Germany

  • LWL-Klinik Dortmund, Bereich Forschung & Wissenschaft

    RECRUITING

    Dortmund, 44287, Germany

  • Medical University Innsbruck

    RECRUITING

    Innsbruck, Austria

  • Universita degli Studi di Brescia

    RECRUITING

    Brescia, Italy

  • University Hospital Frankfurt am Main - Goethe University

    RECRUITING

    Frankfurt am Main, Germany

  • University of Cagliari

    RECRUITING

    Cagliari, Italy

  • Università degli studi della Campania Luigi Vanvitelli

    RECRUITING

    Naples, 80138, Italy

  • Universitätsklinik für Psychiatrie und Psychotherapie Bielefeld

    RECRUITING

    Bielefeld, Germany

  • Westfälische Wilhelms-Universität Münster

    RECRUITING

    Münster, Germany

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