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New treatment option for Schizophrenia
Official title Biomarkers in Clozapine-responding Schizophrenia
ClinicalTrials.gov ID: NCT05316883
What this study is testing
What is Clozapine?
Clozapine is an investigational medicine, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The outline of the current project is to establish a cohort of patients with treatment refractory schizophrenia eligible for clozapine, to identify clinical and biological characteristics of clozapine responding patients. Patients will be offered treatment with clozapine according to national clinical guidelines.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- According to ICD-10 fulfill diagnostic criteria for schizophrenia (F20.x), chronical paranoid psychoses (F22), Schizoaffective psychoses (F25) or...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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).
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glostrup Municipality, Denmark, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glostrup Municipality, Denmark, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.