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NCT05316883: BiCS
Biomarkers in Clozapine-responding Schizophrenia
Phase 4 trial testing Clozapine in Schizophrenia in 200 participants. Currently enrolling.
31 December 2029
Quick facts
| Lead sponsor | Jimmi Nielsen |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 200 |
| Start date | 28 February 2021 |
| Primary completion | 31 December 2029 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Clozapine (CLOZAPINE) — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
- Psychosis — all drugs for Psychosis →
Sponsor
Jimmi Nielsen
Who can join
Adults 18 to 64, any sex, with Schizophrenia or Psychosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05316883
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05741502 — An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine · Phase 4 · terminated
- NCT06011460 — Observation of Clozapine Treatment Safety in Bipolar Disorder. · enrolling by invitation
- NCT06159322 — Characterizing Response to Antipsychotics in Schizophrenia · unknown
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
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Other Jimmi Nielsen trials
Trials by the same sponsor.
- NCT06749444 — Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05316883 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jimmi Nielsen
- Last refreshed: 20 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05316883.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing