Conditions: Schizophrenia
Keywords: Intramuscular ziprasidone, agitation, efficacy and safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 376
Healthy volunteers: no

Brief summary:
This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Intramuscular ziprasidone mesylate intervention 2: Intramuscular haloperidol
Intervention descriptions: intervention 1: The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days. intervention 2: The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.

Protocol document: