An Active-Controlled Early Phase Study of MK-8189 in Adults With Schizophrenia (MK-8189-005)
Status:
Completed
Trial end date:
2018-01-09
Target enrollment:
Participant gender:
Summary
This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial
of MK-8189 compared with placebo, using Risperidone as an active control. The participants
will be adult subjects experiencing an acute episode of schizophrenia, according to the
criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed.
(DSM-5). This study will be up to 7 weeks in duration, with up to 7 site visits for each
participant. The study will consist of a Screening/tapering period (up to one week long), a
4-week treatment period, and a 14-day follow-up period. The primary objective will be to
assess symptoms of schizophrenia at 4 weeks, and to assess safety and tolerability during
treatment and post-treatment follow-up. The secondary objective will be to assess the
severity of schizophrenia at 4 weeks. The primary hypothesis is that MK-8189 is superior to
placebo in reducing the overall symptoms of schizophrenia as assessed by the mean change from
baseline in the Positive and Negative Syndrome Scale (PANSS) total score after 4 weeks of
treatment.