A Study to Test the Safety and Efficacy of MK-8998 in Acutely Psychotic Participants With Schizophrenia (MK-8998-004)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Comparator: Olanzapine; Drug: Comparator: Placebo; Drug: MK-8998

Study type: Interventional

Funder types: Industry

Identifiers

NCT00827918

8998-004

2009_519

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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216 participants in 3 patient groups, including a placebo group

MK-8998

Experimental group

Description:

MK-8998, 6 mg twice a day (BID) for Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period

Treatment:

Drug: MK-8998

Olanzapine

Active Comparator group

Description:

Olanzapine, 5 mg BID for Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period

Treatment:

Drug: Comparator: Olanzapine

Placebo

Placebo Comparator group

Description:

Placebo Comparator to MK-8998 or olanzapine

Treatment:

Drug: Comparator: Placebo