Schizophrenia Clinical Trials

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Biomarkers in Clozapine-responding Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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. Before clozapine is initiated, patients will be offered a thoroughly neurobiological examination, and re-examination will be carried out after 12 weeks of treatment. The primary focus of the examinations will be immunological markers and autoantibodies in the blood and cerebrospinal fluid, permeability of the blood-brain barrier and magnetic resonance imaging of structural, neurochemical and functional brain changes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Denmark
Mental Health Services Glostrup, Unit for Complicated Schizophrenia
RECRUITING
Glostrup Municipality
Contact Information
Primary
Jimmi Nielsen, PhD
jimmi.nielsen@regionh.dk
4538640885
Backup
Mette Nielsen, PhD
mette.oedegaard.nielsen@regionh.dk
Time Frame
Start Date: 2021-02-28
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 200
Treatments
Other: clozapine treatment
Open label clozapine will be given to all participants in clinical doses adjusted to sideeffects and clinical effect
Related Therapeutic Areas
Sponsors
Leads: Jimmi Nielsen

This content was sourced from clinicaltrials.gov