A Study to Test the Safety and Efficacy of MK8998 in Acutely Psychotic Patients With Schizophrenia


Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateFebruary 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: January 22, 2009)
Evaluate the efficacy of MK8998, twice daily, compared to placebo in patients undergoing an acute psychotic episode of schizophrenia as measured by the mean change from baseline in the Positive and Negative Syndrome Scale [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00827918 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 22, 2009)
Evaluate the safety and tolerability of MK8998, twice daily, compared to placebo in patients undergoing an acute psychotic episode of schizophrenia [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study to Test the Safety and Efficacy of MK8998 in Acutely Psychotic Patients With Schizophrenia
Official Title  ICMJEA Phase IIa, Randomized, Multicenter, Double-Blind, Active Comparator- and Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of MK8998 in Acutely Psychotic Patients With Schizophrenia
Brief Summary

A study to evaluate the safety and efficacy of treatment with MK8998 as compared to placebo and olanzapine for acutely psychotic patients with schizophrenia.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJESchizophrenia
Intervention  ICMJE
  • Drug: MK8998
    MK8998 6 mg capsules twice daily with food on Days 1 through 7. On Day 8, dosage will be changed to 8 mg capsules twice daily. Treatment period of 4 weeks. There will be a period of time when all patients will receive placebo.
  • Drug: Comparator: olanzapine
    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 of 4 weeks. There will be a period of time when all patients will receive placebo.
  • Drug: Comparator: Placebo
    Placebo tablets matching olanzapine tablets and MK8998 twice daily with food for a treatment period of 14 days. There will be a period of time when all patients will receive placebo.
Study Arms / Comparison Groups
  • 1: Experimental
    MK8998
    Intervention: Drug: MK8998
  • 2: Active Comparator
    olanzapine
    Intervention: Drug: Comparator: olanzapine
  • 3: Placebo Comparator
    Placebo Comparator
    Intervention: Drug: Comparator: Placebo
Publications *Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, Zhao J, Xu X, Williams-Diaz A, Rodgers AJ, Barnard RJ, Miller MD, DiNubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009 Sep 5;374(9692):796-806. Epub 2009 Aug 3.

Recruitment Information

Estimated Enrollment  ICMJE205
Estimated Completion DateFebruary 2010
Estimated Primary Completion DateFebruary 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 occured while consistently taking a therapeutic dose (10 mg or more) of olanzapine OR olanzapine is medically contradicted
  • Patient is refractory to antipsychotic treatment
GenderBoth
Ages18 Years to 55 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE 
Location Countries  ICMJECroatia,   Russian Federation,   Serbia

Administrative Information

NCT ID  ICMJENCT00827918
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2009_519, MK8998-004
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck