A Study to Test the Safety and Efficacy of MK-8998 in Acutely Psychotic Participants With Schizophrenia (MK-8998-004)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: MK-8998; Comparator: Olanzapine; Comparator: Placebo
Intervention description: MK-8998 6 mg capsules twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 8 mg capsules twice daily. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo.; Olanzapine 5 mg tablets twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 5 mg tablets in the morning and 10 mg tablets in the evening. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo.; Placebo tablets matching olanzapine tablets and MK-8998 capsules
Intervention MeSH terms: Olanzapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Acute Exacerbation of Schizophrenia

Summary:

      A study to evaluate the safety and efficacy of treatment with MK-8998 as compared to placebo
      and olanzapine for acutely psychotic patients with schizophrenia. The primary hypothesis is
      that in participants undergoing an acute psychotic episode of schizophrenia, MK-8998 6 to 8
      mg twice daily is superior to placebo in the treatment of symptoms of schizophrenia as
      measured by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS)
      total score at Week 4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient's age is 18 to 55

          -  Patient meets DSM-IV/DSM-IV-TR criteria for a primary diagnosis of schizophrenia

          -  The duration of the patients schizophrenia diagnosis must be greater than 1 year

          -  Patient has an acute exacerbation of psychotic symptoms (of at least 3 days but no
             longer than 6 weeks) and marked deterioration of function

        Exclusion Criteria:

          -  Patient currently has a clinically significant neurological, metabolic, hepatic,
             renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological
             disorder that would pose a risk to the patient in the opinion of the investigator if
             they were to participate in the study or that might confound the results of the study

          -  The patient has evidence of acute hepatitis, clinically significant chronic hepatitis,
             or impaired hepatic function

          -  The patient has a chronic organic disease of the central nervous system (other than
             schizophrenia) such as, tumors, inflammation, active seizure disorder, vascular
             disorder, Parkinson's disease, Alzheimer's disease or other forms of dementia,
             myasthenia gravis, or other degenerative processes. In addition, patients must not
             have a history of mental retardation or persistent neurological symptoms attributable
             to serious head injury

          -  Patient has a history of alcohol/drug dependence within 3 months or alcohol/drug abuse
             within 1 month of screening. Exceptions include caffeine and nicotine abuse/dependence

          -  Patient has a history of hypersensitivity to olanzapine OR poor response to olanzapine
             in the last 2 years OR intolerable side effects due to olanzapine OR patients current
             psychotic relapse occurred while consistently taking a therapeutic dose (10 mg or
             more) of olanzapine OR olanzapine is medically contradicted

          -  Patient is refractory to antipsychotic treatment