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November 1, 1996Clinical Pharmacology & Therapeutics

Concentration-related pharmacodynamic effects of thioridazine and its metabolites in humans

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Why the study?

Does single-dose thioridazine affect ventricular repolarization and blood pressure in healthy male subjects?

Population

9 healthy male subjects

Comparison

Single doses of thioridazine (10 mg and 50 mg) vs Placebo

Design

RCT, randomized-order crossover, double-blind

Follow-up

72 hours after administration

Authors

KHKenneth Hartigan‐GoMercy San Juan Medical CenterDBD. Nicholas BatemanUniversity Hospitals of Leicester NHS TrustGNG. NybergSahlgrenska University Hospital

Discussion

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Implication

Thioridazine warrants QTc and orthostatic BP monitoring; confirms direct repolarization and hemodynamic effects in this RCT.

Structured PICO

Does single-dose thioridazine affect ventricular repolarization and blood pressure in healthy male subjects?

P
Population
9 healthy male subjects
I
Intervention
Single doses of thioridazine (10 mg and 50 mg)
C
Comparator
Placebo
O
Outcome
Cardiac and other effects (ECG, blood pressure, salivary flow, and psychomotor tests) and their relation to plasma concentration of the parent drug and its principal metabolitessurrogate

Thioridazine exhibits dose-related effects on ventricular repolarization (QTc prolongation) and blood pressure, primarily driven by the parent drug.

Cite This Study

Hartigan‐Go et al. (1996) studied this question.

synapsesocial.com/papers/6a89b577a90c2f4c44fba35ehttps://doi.org/10.1016/s0009-9236(96)90150-2
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Also Consider

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  1. 1Thioridazine Hydrochloride (Mellaril): Its Effect on the Electrocardiogram and a Report of Two Fatalities with Electrocardiographic Abnormalities1963 · 187 citations
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  3. 3Mortality in a Cohort of Patients with Schizophrenia: A Record Linkage Study*1991 · 372 citations
  4. 4Genetic and metabolic criteria for the assignment of debrisoquine 4-hydroxylation (cytochrome P4502D6) phenotypes1991 · 92 citations