Conditions: Bipolar I Disorder
Keywords: Bipolar 1 disorder, agitation, acute, treatment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 314
Healthy volunteers: no

Brief summary:
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

Detailed description:
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Arms:
arm 1: Inhaled Staccato Placebo, may repeat after 2 hours x 2 arm 2: Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2 arm 3: Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2

Interventions: intervention 1: Inhaled Placebo intervention 2: Inhaled loxapine 5 mg intervention 3: Inhaled loxapine 10 mg
Intervention descriptions: intervention 1: Inhaled loxapine Placebo, may repeat after 2 hours x 2 intervention 2: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2 intervention 3: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2

Protocol document: