Conditions: Schizophrenia
Keywords: Schizophrenia Antipsychotic Agents Mental Disorder Psychotropic Drugs Dopamine Agents Risperidone Central Nervous System Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 254
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: MP-214 3mg intervention 2: MP-214 6mg intervention 3: MP-214 9mg intervention 4: Risperidone 4mg
Intervention descriptions: intervention 1: 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). intervention 2: 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). intervention 3: 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). intervention 4: 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).

Protocol document: