ArticleBritish journal of clinical pharmacology2026
An open-label, single-arm, dose-escalating concentration-QT study to investigate the cardiac effects and safety of paroxetine in healthy adults.
Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06065735 (An Open-Label, Single Arm, Dose Escalating Concentration-QT Study to Investigate the Cardiac Effects and Safety of Paroxetine in Healthy Adult Participants), which is not on this map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Single Arm, Dose Escalating Concentration-QT Study to Investigate the Cardiac Effects and Safety of Paroxetine in Healthy Adult Participants
Who cites it
2 citing papers in PubMed.
- Comment on 'An open-label, single-arm, dose-escalating concentration-QT study to investigate the cardiac effects and safety of paroxetine in healthy adults'.British journal of clinical pharmacology · 2026Article
- An open-label, single-arm, dose-escalating concentration-QT study to investigate the cardiac effects and safety of paroxetine in healthy adults.British journal of clinical pharmacology · 2026Article
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Authors and funding
7 authors.
Funding
Abstract
aimsParoxetine is a selective serotonin reuptake inhibitor (SSRI), approved for treatment of major depressive disorder and anxiety disorders. Some SSRIs are known to prolong the QT interval; however, clinical evidence to establish a lack of association between paroxetine and corrected QT interval (QTc) prolongation is limited. Therefore, this study aimed to characterize the relationship between paroxetine concentration and QT/QTc interval following therapeutic doses in healthy individuals.
methodsThis open-label, single-arm, dose-escalating concentration-QT study (NCT06065735) was performed in healthy adults (18-65 years) without a history of cardiac disease or pre-diagnosed mood disorder. Eligible individuals (n = 38) received paroxetine 20 to 60 mg QD for 1 week per dose level. Paroxetine plasma concentrations and electrocardiogram recordings were monitored over a 12 h period on Days 1 (baseline), 7 (20 mg), 14 (40 mg) and 21 (60 mg).
resultsMean change from baseline in QTcF (ΔQTcF) fluctuated between -7.1 and +4.7 ms. However, diurnal variation was also observed without treatment. A linear regression model showed no clinically significant effect of paroxetine concentrations on ΔQTcF, with a weak slope of 0.0108 ms/ng/mL (90% CI: 0.01, 0.03) and maximum ΔQTcF of +0.42 ms (90% CI: -2.68, 3.52) at 60 mg QD, corresponding to a Cmax of 221.4 (95%CI: 179.6-272.8) ng/mL. Similarly, paroxetine did not affect the mean change in PR or QRS interval, or heart rate relative to baseline.
conclusionsParoxetine does not prolong QTc interval in healthy individuals to any clinically meaningful extent at therapeutically relevant doses. This study supports the favourable cardiac safety profile of paroxetine.
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