Conditions: Schizophrenia
Keywords: Schizophrenia Antipsychotic Agents Acute Schizophrenia Mental Disorder Psychotropic Drugs Dopamine Agents Risperidone Central Nervous System Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 512
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: MP-214 3mg intervention 2: MP-214 6mg intervention 3: MP-214 9mg intervention 4: Risperidone 4mg intervention 5: Placebo
Intervention descriptions: intervention 1: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks. intervention 2: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks. intervention 3: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks. intervention 4: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks. intervention 5: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.

Protocol document: