Scientists hunt for clues to why clozapine works for some with schizophrenia
NCT ID NCT05316883
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is looking at 200 people with treatment-resistant schizophrenia who are starting clozapine. Researchers will measure immune markers in blood and spinal fluid, brain scans, and other tests before and after 12 weeks of treatment. The goal is to find biological signs that predict who will respond well to clozapine, which could help tailor treatment in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Clozapine
- What this could lead to
- If successful, this could help doctors identify which patients are most likely to respond to clozapine, leading to more personalized treatment for schizophrenia.
- What could go wrong
- This is an observational study focused on biomarkers, not a treatment trial. It may not directly improve outcomes, and results may not apply to all patients with schizophrenia.
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
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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 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Dec 2029
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 64 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: * According to ICD-10 fulfill diagnostic criteria for schizophrenia (F20.x), chronical paranoid psychoses (F22), Schizoaffective psychoses (F25) or other non-organic psychoses (F28/F29); * Age 18-65 years; * Legally competent; * Stabil antipsychotic treatment during last month * Being treatment refractory according to TRIPP-guidelines (Howes et al. 2017) defined as having tried at least two antipsychotic drugs in sufficient dosage (≥600 mg chlorpromazine equivalent) for a sufficient time (≥ 6 weeks) without sufficient symptom improvement (still a moderate level of positive symptoms). * Recreational use of substances is allowed as long as it does not interfere with compliance * Fertile females must use safe contraception (spiral or any hormonal contraception). Exclusion Criteria: * Involuntarily psychiatric admittance during the study * Substance abuse that interfere with compliance * Pregnancy (will be verified by urine-HCG-test in fertile females) * Toxic or idiosyncratic agranulocytosis in the past * Reduced bone marrow function according to blood samples * According to information from patient and available files, noUncontrolled * Current uncontrolled epilepsy * Current circulatory collapse and / or CNS depression for any cause * Current severe kidney, heart or liver disease * Current paralytic ileus
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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
1 site. 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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Mental Health Services Glostrup, Unit for Complicated Schizophrenia
RECRUITINGGlostrup Municipality, Denmark, 2600, Denmark
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