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Is inhaled loxapine effective for acute treatment of agitation in schizophrenia?
344 adults with DSM-IV schizophrenia who were in good general health and were agitated (Positive and Negative Syndrome Scale Excited Component (PANSS-EC) total score of ≥14 out of 35 and a score of ≥4 out of 7 on at least one of the five items). Participants were recruited from people admitted to hospital or a research unit, people already hospitalised for treatment of schizophrenia and individuals who were treated at a psychiatric emergency department.
24 psychiatric research facilities, USA; February to June 2008.
Inhaled loxapine 5 mg, inhaled loxapine 10 mg or inhaled placebo. Treatments were delivered by the Staccato system up to three times within a 24 h period. Dose 2 could be delivered if agitation had not subsided >2 h after dose 1, and dose 3 could be given ≥4 h after dose 2 if needed. Rescue intramuscular lorazepam was only allowed if it was >2 h after dose 1, if dose 2 had been given and if it was ≥20 min since the last dose of study medication.
Agitation at 2 h after dose 1 (primary measure: …
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