Staccato Loxapine in Agitated Patients With Bipolar Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Bipolar I Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inhaled Placebo

Inhaled Staccato Placebo, may repeat after 2 hours x 2

Group Type PLACEBO_COMPARATOR

Inhaled Placebo

Intervention Type DRUG

Inhaled loxapine Placebo, may repeat after 2 hours x 2

Inhaled Loxapine 5 mg

Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2

Group Type EXPERIMENTAL

Inhaled loxapine 5 mg

Intervention Type DRUG

Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2

Inhaled Loxapine 10 mg

Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2

Group Type EXPERIMENTAL

Inhaled loxapine 10 mg

Intervention Type DRUG

Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2

Interventions

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Inhaled Placebo

Inhaled loxapine Placebo, may repeat after 2 hours x 2

Intervention Type DRUG

Inhaled loxapine 5 mg

Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2

Intervention Type DRUG

Inhaled loxapine 10 mg

Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2

Intervention Type DRUG

Other Intervention Names

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Staccato Placebo ADASUVE 5 mg ADASUVE 10 mg

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No