Long-Term Study of MP-214 in Patients With Schizophrenia

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Schizophrenia
Interventions
DRUG

MP-214 3mg

In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).

DRUG

MP-214 6mg

In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).

DRUG

MP-214 9mg

In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).

DRUG

Risperidone 4mg

In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4. In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).

Trial Locations (3)

Unknown

Sapporo

Seoul

Taipei

All Listed Sponsors
lead

Mitsubishi Tanabe Pharma Corporation

INDUSTRY