NCT01625000

Safety and Efficacy of MP-214 in Patients With Schizophrenia

A Double-Blind, Placebo-Controlled Study of MP-214 in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 512 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	MP-214 3mg	Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
DRUG	MP-214 6mg	Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
DRUG	MP-214 9mg	Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
DRUG	Risperidone 4mg	Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
DRUG	Placebo	Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-08-01
• Completion: 2015-10-01
• First posted: 2012-06-21
• Last updated: 2026-01-05
• Results posted: 2021-04-12

Locations

3 sites across 3 countries: Japan, South Korea, Taiwan