Phase 3
Completed N=314
Staccato Loxapine in Agitated Patients With Bipolar Disorder
Source: ClinicalTrials.gov NCT00721955 ↗Enrolled (actual)
314
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo — -4.9; -8.1; -9.0 units on a scale — p=<0.0001
◆ Published Evidence
Emerging
10citations · ~1 / year
Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses.
Summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
Linked Publications
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Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo |
-4.9; -8.1; -9.0 | <0.0001 sig |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo |
3.0; 2.1; 1.9 | <0.0001 sig |
| SECONDARY CGI-I Responders |
29; 69; 78 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female adult patients with bipolar 1 disorder and acute agitation
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
Data sourced from ClinicalTrials.gov (NCT00721955) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.