Staccato Loxapine in Agitated Patients With Schizophrenia

Phase 3

Completed

Interventions: Drug: Inhaled loxapine 5 mg
Drug: Inhaled loxapine 10 mg
Drug: Inhaled placebo

Brief Summary: Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Agitation caused primarily by acute intoxication
History of drug or alcohol dependence
Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration

Arm && Interventions

Group	Intervention	Description
Inhaled Loxapine 5 mg	Inhaled loxapine 5 mg	Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
Inhaled Loxapine 10 mg	Inhaled loxapine 10 mg	Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
Inhaled placebo	Inhaled placebo	Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours

Primary Outcome Measures

Name	Time	Method
Change in PANSS-EC From Baseline	Baseline and 2 hours	The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Improvement (CGI-I) Score	Baseline and 2 hours	Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
CGI-I Responders	Baseline and 2 hours	Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)