急性期統合失調症患者におけるMK-8189の有効性と安全性（MK-8189-008）

基本情報

NCT ID

NCT04624243

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

499

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purpose of this study was to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily \[QD\]) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria. The primary hypotheses were the following: (1) that MK-8189 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score, and (2) that MK-8189 16 mg is superior to placebo in reducing the Week 6 mean change from baseline in PANSS total score. With Amendment 4, enrollment was changed to approximately 500 participants with removal of the MK-8189 8 mg treatment arm. Participants enrolled before Amendment 4 who were assigned to MK-8189 8 mg QD remained on that dose regimen per protocol.

対象疾患

介入

依頼者（Sponsor）

実施施設 (22)