Trial · NCT07913529
Time Course of Clozapine-associated Agranulocytosis Over 19 Years
NCT07913529, Completed, Sheba Medical Center
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Time Course of Clozapine-associated Agranulocytosis Over 19 Years. Trials, record NCT07913529. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07913529
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Time Course of Clozapine-associated Agranulocytosis Over 19 Years
- NCT number
- NCT07913529
- Status
- Completed
- Enrollment
- 2,020 participants, actual
- Lead sponsor
- Sheba Medical Center
- Conditions
- Agranulocytosis, Neutropenia, SCHIZOPHRENIA 1 (Disorder), Treatment-resistant Schizophrenia
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Incidence of Clozapine-Associated Agranulocytosis | From first documented clozapine exposure up to 48 months (primary window); extended analysis up to approximately 19 years | Agranulocytosis defined as at least two absolute neutrophil count (ANC) measurements below 0.5 x 10\^9/L within one week; event date is the first qualifying measurement. Cumulative incidence estimated as 1 minus the Kaplan-Meier survival function, reported at 18 weeks, 12 months and 48 months, and in the extended analysis at 60, 120 and 180 months. Events adjudicated as chemotherapy- or malignancy-related, or reflecting an erroneous index date, are excluded from the primary analysis. |
| Secondary | Incidence Rate of Agranulocytosis by Follow-Up Period | From first documented clozapine exposure up to approximately 19 years | Incidence rate per 1,000 person-years with Poisson 95% confidence intervals across follow-up intervals: 0-18 weeks, 18 weeks-6 months, 6-12, 12-24, 24-60, 60-120 and \>120 months. Stability of the rate after 18 weeks assessed with Poisson regression and Weibull survival modeling. |
| Secondary | Association of Age, Sex and Psychiatric Diagnosis With Agranulocytosis | Within 48 months of first clozapine exposure and across the full follow-up (up to approximately 19 years) | Odds ratios from Firth penalized logistic regression, with an unpenalized Cox proportional hazards model as a robustness check, for age at index date, sex and psychiatric diagnosis (ICD-9) as predictors of agranulocytosis. |
| Secondary | Proportion of Laboratory-Defined Cases Attributable to Clozapine After Case-Level Adjudication | Through study completion, an average of 1 year | Number and percentage of laboratory-defined agranulocytosis cases classified, through structured case-level review, as likely clozapine-related versus neutropenia related to malignancy or cytotoxic chemotherapy, or events reflecting an erroneous index date. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07913529
GET https://conductscience.org/api/trials/v1/NCT07913529/registered