Investigation of Adverse Drug Reactions to Clozapine in Relation to Genotype, Serum Concentration (TDM), Age, Ethnicity, and Gender—CLOVER

Investigation of Adverse Drug Reactions to Clozapine in Relation to Genotype, Serum Concentration (TDM), Age, Ethnicity, and Gender—CLOVER - CLOVER

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039627

Enrollment

100

Registered

2026-07-06

Start date

2026-06-12

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F20.0

Interventions

Group 1: Patients who are newly being treated with clozapine for schizophrenia spectrum disorders. A blood sample will be drawn for genotyping. Clinical interviews will be conducted several times. Thi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Schizophrenia spectrum disorder, treatment with clozapine

Exclusion criteria

Exclusion criteria: Lack of legal capacity to consent

Design outcomes

Primary

Measure	Time frame
Occurrence of side effects of clozapine, such as hypersalivation, constipation, and pneumonia (fever). Weekly surveys for side effects.	—

Secondary

Measure	Time frame
PANSS, GASS-C, CGI, ED-5D-5L, OCI-R, MARS, LUNSERS, B-CATS; clozapine concentrations (TDM), genotyping via long-read sequencing to identify and confirm genetic variants associated with adverse effects. Lyphocytes transformation test result in patients who develop myocarditis	—

Countries

Germany

Contacts

Public ContactRobert Bittner

Universitätsmedizin Frankfurt, Klinik für Psychiatrie, Psychosomatik und Psychotherapie

robert.bittner@unimedzin-ffm.de+49-69 / 6301-1

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026