Conditions: Schizophrenia
Keywords: Agitation Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 129
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients. The study will be conducted in 120 agitated schizophrenic patients - either newly admitted to a hospital setting or a research unit for acute agitation or already in hospital for chronic underlying conditions. Patients meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to Staccato Placebo. Following administration of study drug, assessment of agitation state will be conducted at serial time points using standard agitation scales over a 24 hour period.

Detailed description:

Arms:
arm 1: Inhaled Staccato Placebo, single dose arm 2: Inhaled Staccato Loxapine 5 mg, single dose arm 3: Inhaled Staccato Loxapine 10 mg, single dose

Interventions: intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine 5 mg intervention 3: Inhaled Loxapine 10 mg
Intervention descriptions: intervention 1: Inhaled Placebo, single dose intervention 2: Inhaled Staccato Loxapine 5 mg, single dose intervention 3: Inhaled Staccato Loxapine 10 mg, single dose

Protocol document: