Phase 2 N=216 Randomized Triple-blind Treatment

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

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00827918 ↗

Enrolled (actual)

216

Serious AEs

0.5%

Results posted

Feb 2014

Primary outcome: Primary: Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) at Week 4 — -13.3; -17.0; -12.7 Units on a scale — p=0.8590

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: MK-8998 (Drug); Comparator: Olanzapine (Drug); Comparator: Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) at Week 4	-13.3; -17.0; -12.7	0.8590
PRIMARY Number of Participants Who Experienced at Least One Adverse Event	41; 23; 33	—
PRIMARY Number of Participants Who Discontinued Study Drug Due to an Adverse Event	9; 1; 1	—
SECONDARY Percentage of Participants With Response at Week 4	57.4; 66.7; 48.3	0.4976
SECONDARY Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) at Week 4	-0.9; -0.8; -0.9	0.8199
SECONDARY Mean Change From Baseline in PANSS Positive Subscale at Week 4	-4.2; -5.6; -4.2	0.9937
SECONDARY Mean Change From Baseline in PANSS Negative Subscale at Week 4	-3.3; -3.1; -2.9	0.5953

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00827918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.