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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00827918
First received: January 22, 2009
Last updated: June 22, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Schizophrenia
 Drug: MK8998
Drug: Comparator: olanzapine
Drug: Comparator: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 216
Study Start Date: March 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK8998
 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.
Active Comparator: 2
olanzapine
 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.
Placebo Comparator: 3
Placebo Comparator
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 occured while consistently taking a therapeutic dose (10 mg or more) of olanzapine OR olanzapine is medically contradicted
  • Patient is refractory to antipsychotic treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827918

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00827918     History of Changes
Other Study ID Numbers: 2009_519, MK8998-004
Study First Received: January 22, 2009
Last Updated: June 22, 2010
Health Authority: Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Merck:
Acute Exacerbation of Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013