Autonomic signs and dosing during the initial stages of clozapine therapy.
Bibliographic record
Abstract
BACKGROUND: Recent reports implicate clozapine in heart rate variability, QTc prolongation, torsade de pointes and sudden death at therapeutic doses, even in physically healthy patients. This study aims to examine whether autonomic (vital) signs are correlated with clozapine dose titration and blood levels of clozapine and nor-clozapine during clozapine therapy. MATERIAL/METHODS: Thirty-seven consecutive patients with diagnosis of schizophrenia treated with clozapine were included in this prospective longitudinal study. The study was restricted to only the first 8 weeks of treatment. After obtaining informed consent, serum concentrations of clozapine and nor-clozapine were determined weekly at trough, as doses were administered q12h and adjusted according to clinical guidelines for clozapine use. Autonomic signs including BP (supine and erect), pulse (supine and erect) and temperature were monitored daily each morning before and one hour after the morning's dose of clozapine was administered. RESULTS: We calculated analyses of covariance (ANCOVAs) to evaluate the changes in vital signs parameters, from baseline to week 8, with clozapine variables as covariates (i.e, the dose of clozapine, as well as the levels of serum clozapine and nor-clozapine). The blood pressure and pulse did not change significantly (p<0.01) from baseline to weeks 8. The temperature was inversely related to clozapine dose (p<0.003). Higher nor-clozapine to clozapine ratios were associated with higher BP measures (p=0.002). The magnitude of these relationships is weak (r<0.30). CONCLUSIONS: There is a tendency to autonomic dysregulation during clozapine use. This has cardiac function implications, justifying cautious dose adjustment with frequent monitoring of vital signs.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".