A Study to Test the Safety and Efficacy of MK8998 in Acutely Psychotic Patients With Schizophrenia
Tracking Information
Start Date ICMJE | March 2009 |
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Estimated Primary Completion Date | February 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 ICMJE | Same as current |
Change History | Complete 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 ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study to Test the Safety and Efficacy of MK8998 in Acutely Psychotic Patients With Schizophrenia |
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Official Title ICMJE | 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 |
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 Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Schizophrenia |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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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 ICMJE | 205 |
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Estimated Completion Date | February 2010 |
Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 55 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | Croatia, Russian Federation, Serbia |
Administrative Information
NCT ID ICMJE | NCT00827918 | ||||
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Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
Study ID Numbers ICMJE | 2009_519, MK8998-004 | ||||
Study Sponsor ICMJE | Merck | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Merck |
Source: http://clinicaltrials.gov/