January 28, 2020Progress in Neuro-Psychopharmacology and Biological PsychiatryOpen Access

No clinically concerning QTc effect (placebo-corrected ΔQTcF ≥10 msec) was observed across the OLZ/SAM dose range tested, with a predicted ΔΔQTcF of 2.33 msec (90% CI -2.72 to 7.38) at the observed geometric mean maximal concentration of olanzapine on day 13.

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Why the study?

This thorough QT study was conducted to assess the effects of therapeutic and supratherapeutic doses of OLZ/SAM on cardiac repolarization in patients with schizophrenia.

Does the combination of olanzapine and samidorphan prolong the QTcF interval in patients with stable schizophrenia?

Population

100 patients aged 18 to 60 years with stable schizophrenia

Comparison

OLZ/SAM (10/10 to 30/30 mg) vs placebo and moxifloxacin 400 mg

Design

Randomized, double-blind, placebo- and positive-controlled parallel-group trial

Follow-up

14 days

Authors

LSLei Sun SYSergey Yagoda HXHongqi Xue

Discussion

Member takes

Overview

Supports OLZ/SAM use without QTc monitoring in stable schizophrenia; confirms cardiac safety from this RCT.

Structured PICO

Does the combination of olanzapine and samidorphan prolong the QTcF interval in patients with stable schizophrenia?

Population

100 patients aged 18 to 60 years with stable schizophrenia.

Intervention

Olanzapine/samidorphan (OLZ/SAM) escalating doses: 10/10 mg on days 2-4, 20/20 mg on days 5-8, and supratherapeutic dose of 30/30 mg on days 9-13, plus moxifloxacin-matched placebo on days 1 and 14.

Comparator

Single oral dose of moxifloxacin 400 mg and moxifloxacin-matched placebo on days 1 and 14 in a nested crossover fashion, along with OLZ/SAM-matched placebo on days 2-13.

Outcome

Change from baseline in QT interval with Fridericia's correction (ΔQTcF)surrogate

The combination of olanzapine and samidorphan does not cause clinically relevant QT prolongation, even at supratherapeutic doses, supporting its cardiac safety profile.

Cite This Study

Sun et al. (2020) studied this question.

synapsesocial.com/papers/6a821b3bf2e4e6540e2a4d6b https://doi.org/10.1016/j.pnpbp.2020.109881

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January 28, 2020Progress in Neuro-Psychopharmacology and Biological PsychiatryOpen Access

No clinically concerning QTc effect (placebo-corrected ΔQTcF ≥10 msec) was observed across the OLZ/SAM dose range tested, with a predicted ΔΔQTcF of 2.33 msec (90% CI -2.72 to 7.38) at the observed geometric mean maximal concentration of olanzapine on day 13.

View Full Paper

Ask AI

Bookmark

Why the study?

This thorough QT study was conducted to assess the effects of therapeutic and supratherapeutic doses of OLZ/SAM on cardiac repolarization in patients with schizophrenia.

Does the combination of olanzapine and samidorphan prolong the QTcF interval in patients with stable schizophrenia?

Population

100 patients aged 18 to 60 years with stable schizophrenia

Comparison

OLZ/SAM (10/10 to 30/30 mg) vs placebo and moxifloxacin 400 mg

Design

Randomized, double-blind, placebo- and positive-controlled parallel-group trial

Follow-up

14 days

Authors

LSLei Sun SYSergey Yagoda HXHongqi Xue

Discussion

Member takes

Overview

Supports OLZ/SAM use without QTc monitoring in stable schizophrenia; confirms cardiac safety from this RCT.

Structured PICO

Does the combination of olanzapine and samidorphan prolong the QTcF interval in patients with stable schizophrenia?

Population

100 patients aged 18 to 60 years with stable schizophrenia.

Intervention

Olanzapine/samidorphan (OLZ/SAM) escalating doses: 10/10 mg on days 2-4, 20/20 mg on days 5-8, and supratherapeutic dose of 30/30 mg on days 9-13, plus moxifloxacin-matched placebo on days 1 and 14.

Comparator

Single oral dose of moxifloxacin 400 mg and moxifloxacin-matched placebo on days 1 and 14 in a nested crossover fashion, along with OLZ/SAM-matched placebo on days 2-13.

Outcome

Change from baseline in QT interval with Fridericia's correction (ΔQTcF)surrogate

The combination of olanzapine and samidorphan does not cause clinically relevant QT prolongation, even at supratherapeutic doses, supporting its cardiac safety profile.

Cite This Study

Sun et al. (2020) studied this question.

synapsesocial.com/papers/6a821b3bf2e4e6540e2a4d6b https://doi.org/10.1016/j.pnpbp.2020.109881

View Full Paper

Ask AI

Bookmark