Could a quick switch to stronger meds change schizophrenia care?
NCT ID NCT05958875
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 418 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
13 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"
RECRUITINGTurin, Italy
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Bezirkskliniken Schwaben, Bezirkskrankenhaus Augsburg
NOT_YET_RECRUITINGAugsburg, 86156, Germany
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Fundació Clínic per a la Recerca Biomèdica
RECRUITINGBarcelona, Spain
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King's College London, Psychiatry & Cognitive Neuroscience
RECRUITINGLondon, SE5 8AF, United Kingdom
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Klinik für Psychiatrie und Psychotherapie der Universitätsmedizin Mainz
RECRUITINGMainz, Germany
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LWL-Klinik Dortmund, Bereich Forschung & Wissenschaft
RECRUITINGDortmund, 44287, Germany
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Medical University Innsbruck
RECRUITINGInnsbruck, Austria
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Universita degli Studi di Brescia
RECRUITINGBrescia, Italy
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University Hospital Frankfurt am Main - Goethe University
RECRUITINGFrankfurt am Main, Germany
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University of Cagliari
RECRUITINGCagliari, Italy
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Università degli studi della Campania Luigi Vanvitelli
RECRUITINGNaples, 80138, Italy
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Universitätsklinik für Psychiatrie und Psychotherapie Bielefeld
RECRUITINGBielefeld, Germany
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Westfälische Wilhelms-Universität Münster
RECRUITINGMünster, Germany
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