drugset / Trial / NCT00628589
Staccato Loxapine in Agitated Patients With Schizophrenia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients
Timeline
- Start
- 2008-02
- Primary completion
- 2008-05
- Completion
- 2008-05
Outcome
Met primary endpoint
registry MEAN Inhaled Placebo: -5.5 (Standard Deviation 4.92) units on a scale MEAN Inhaled Loxapine 5 mg: -8.1 (Standard Deviation 5.17) units on a scale NCT00628589 ↗
registry analysis (superiority test); Inhaled Placebo vs Inhaled Loxapine 5 mg; p = 0.0004; ANCOVA NCT00628589 ↗
registry analysis (superiority test); Inhaled Placebo vs Inhaled Loxapine 10 mg; p <0.0001; ANCOVA NCT00628589 ↗
Publications
- Background Lesem MD, Tran-Johnson TK, Riesenberg RA, Feifel D, Allen MH, Fishman R, Spyker DA, Kehne JH, Cassella JV. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry. 2011 Jan;198(1):51-8. doi: 10.1192/bjp.bp.110.081513.
- Zeller S, Zun L, Cassella JV, Spyker DA, Yeung PP. Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses. BJPsych Open. 2017 Nov 10;3(6):285-290. doi: 10.1192/bjpo.bp.117.005363. eCollection 2017 Nov.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | loxapine | Small molecule | 5 mg | Inhaled |
| Subject | loxapine | Small molecule | 10 mg | Inhaled |
Indications
No indication recorded.