CompletedPhase 2

An Active-Controlled Early Phase Study of Elpipodect (MK-8189) in Adults With Schizophrenia (MK-8189-005)

United States224 participantsStarted 2017-03-08

Plain-language summary

This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial of elpipodect 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 elpipodect 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.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 to 50 years of age at Screening * Male * Female not of reproductive potential (e.g., postmenopausal or has had a hysterectomy), or agrees to practice abstinence or use acceptable contraception * Meets the diagnostic criteria for schizophrenia according to the DSM-5 criteria, or has a past diagnosis of schizophrenia with the onset of the first episode being \>=1 year prior to study entry, and has illness duration of \<=20 years * Is confirmed to be experiencing an acute episode of schizophrenia * Minimum PANSS score \>= 80 at Screening * Has a score of \>=4 in 3 or more of the following items (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution) in the positive subscale of the PANSS at Screening * Has a CGI-S score \>= 4 at Screening * Is able to taper off psychotropic medications without significant destabilization or increased suicidality * Has responded positively to an antipsychotic medication other than clozapine in a prior psychotic episode * Has an identified responsible external contact person who has regular contact (no less than once per week) with the participant Exclusion Criteria: * Is currently under involuntary commitment because he/she is considered a danger to himself/herself or others * Is unwilling to remain hospitalized for the duration of trial treatment * Is currently participating in or has participated in an interventional clinical research study \<=6 months prior to Screenin…

What they're measuring

Least Squares Mean (LSM) Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

Timeframe: Baseline and Week 4

Percentage of Participants Experiencing an Adverse Event (AE)

Timeframe: Up to 6 weeks

Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event

Timeframe: Up to 4 weeks

Trial details

NCT IDNCT03055338

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01-09

Results submitted2018-12-06

View on ClinicalTrials.gov More Schizophrenia, Acute Episode trials