Safety and Efficacy of MP-214 in Patients With Schizophrenia
Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Schizophrenia
Intervention
MP-214 low dose, MP-214 middle dose, MP-214 high dose, Risperidone, Placebo
Location
Sapporo
Hokkaido
Japan
Status
Recruiting
Source
Mitsubishi Tanabe Pharma Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01625000
- Information obtained from ClinicalTrials.gov on January 24, 2013
Medical and Biotech [MESH] Definitions
Lethal Dose 50
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
Maximum Tolerated Dose
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Dose Fractionation
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
Mice, Inbred Sencar
Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.
Radiotherapy, Conformal
Radiotherapy where there is improved dose homogeneity within the tumor and reduced dosage to uninvolved structures. The precise shaping of dose distribution is achieved via the use of computer-controlled multileaf collimators.
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