Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05422131 · ClinicalTrials.gov registry record
Clozapine Therapy Sample Collection - Method Comparison Study
A clinical trial, sponsored by Saladax Biomedical.
- Completed
- Registry status
- 153
- Enrollment target
NCT05422131: Completed study, sponsored by Saladax Biomedical.
NCT05422131 is a clinical trial that has completed, run by Saladax Biomedical. The registered enrollment target is 153 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05422131 has completed, sponsored by Saladax Biomedical.
- COMPLETED
- Registry status
- 153 participants
- Enrollment target
Study Summary
The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine Assay Kit manufactured by SBI, and the point of care MyCare Insite Clozapine Test manufactured by SBI. Clozapine measurements obtained using the MyCare Insite Clozapine Test are intended for investigational purposes only and shall not be used in the management of patients receiving clozapine therapy.
Primary Outcome
Determine if the MyCare Insite Clozapine Test returns blood level results which are equivalent to results obtained using the MyCare Pyschiatry Assay Kit and LC-MS
Interventions
- DEVICE MyCare Insite Clozapine Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2022-11-12 |
| Est. Completion | 2023-05-16 |
What the finished NCT05422131 record still lists
NCT05422131 is an observational study that tracks outcomes without assigning an intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which MyCare Insite Clozapine Test is the first listed.
NCT05422131 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05422131 about?
NCT05422131 is a clinical study titled "Clozapine Therapy Sample Collection - Method Comparison Study". The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psych...
What is the current status of trial NCT05422131?
This trial is currently completed. The enrollment target is 153 participants. The study started on 2022-11-12. Estimated completion is 2023-05-16.
What interventions are being tested in trial NCT05422131?
The interventions under investigation include: MyCare Insite Clozapine Test (DEVICE).
Who is sponsoring clinical trial NCT05422131?
This trial is sponsored by Saladax Biomedical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05283265 · 153 participants · NA
Neurophysiological Mechanisms of Language Comprehension
- NCT05554393 · 153 participants · Phase 2
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
- NCT05584501 · 153 participants · NA
ETE Interventions in the Dental Setting
- NCT05714839 · 153 participants · Phase 1
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI