Trial reportJournal of clinical psychopharmacology
Phase 2b Trial of the PDE10A Inhibitor MK-8189 in People With an Acute Episode of Schizophrenia.
Trial report in Journal of clinical psychopharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04624243 (A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of Schizophrenia), which is not on this map. Cited by 1 paper.
What it found
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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.
A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of Schizophrenia
Who cites it
1 citing paper in PubMed.
- Trial
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPDE10A inhibition represents a potential mechanism for treating schizophrenia. A 12-mg dose of the PDE10A inhibitor MK-8189 showed initial evidence of efficacy for improving schizophrenia symptoms after 4 weeks. We performed a follow-up study evaluating higher MK-8189 doses (16 mg and 24 mg, predicted to produce up to 80% sustained enzyme occupancy) over 6 weeks.
methodsRandomized, double-blind, phase 2b study consisting of a 6-week acute treatment period and a 6-week extension (NCT04624243). Participants were diagnosed with schizophrenia and were experiencing active phase symptoms. For the acute treatment period, participants were randomized in a 2:2:2:1:2 ratio to 6 weeks of daily MK-8189 8 mg (dropped after a third of participants had been enrolled), 16 mg, 24 mg, risperidone 6 mg (for assay sensitivity), or placebo. The primary outcome was the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at 6 weeks.
resultsThe number of treated participants in the acute period was: MK-8189 16 mg, N=132; MK-8189 24 mg, N=132; risperidone 6 mg, N=65; and placebo, N=129. MK-8189 16 mg and 24 mg did not show an improvement versus placebo for change-from-baseline in PANSS total score after 6 weeks [16 mg-placebo difference, -2.8 (95% CI: -8.3,2.6), P =0.241; 24 mg-placebo difference, -0.7 (95% CI: -6.3,4.9), P =0.784], whereas risperidone did [risperidone-placebo difference, -6.2 (95% CI: -12.9,0.6), P =0.040]. Over the 6-week acute period, more participants discontinued treatment due to an adverse event in the MK-8189 24 mg group (25.0%) than in the MK-8189 16 mg (12.9%), risperidone (12.3%) or placebo (12.4%) groups.
conclusionsThese findings suggest that PDE10A inhibition does not have antipsychotic effects at the doses tested.
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