Schizophrenia Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Staccato Loxapine (ADASUVE®) for Inhalation in Acutely Agitated Patients With Schizophrenia or Bipolar Disorder
Verified date | January 2019 |
Source | Lee's Pharmaceutical Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic or bipolar disorder patients.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | August 1, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 1. Male and female patients between the ages of 18 to 65 years, inclusive. - 2. Patients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for schizophrenia or bipolar disorder. - 3. Patients are judged to be clinical mild to moderate agitation at baseline with a total value of = 14, and have a score =4 on at least 1 of 5 items on the PANSS-EC scale, and with a value of =3 on CGI-S scale. - 4. Patients are judged to be cooperative by the Investigator. - 5. Written informed consent from patients (and/or legally acceptable representative, legally acceptable representative preferred) is obtained. Exclusion Criteria: - 1. Patients with agitation caused primarily by Delirium, Dpilepsy, Developmental Retardation, acute alcohol or psychoactive drugs intoxication/withdrawal symptoms (as per Investigator's judgment). - 2. Patients judged to be at serious risk for suicide as per the Investigator's judgement. - 3. Patients with a history of allergy or intolerance to loxapine or amoxapine. - 4. Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding. - 5. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease). - 6. Patients who are considered by the Investigator, for any reason, to be unsuitable candidates for receiving inhaled loxapine, or are likely to be unable to use the inhalation device. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lee's Pharmaceutical Limited |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in PANSS-EC From Baseline | 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. | Time Frame: Baseline and 2 hours | |
Secondary | Change in PANSS-EC From Baseline | Baseline and 30 minutes | ||
Secondary | Change in PANSS-EC From Baseline | Baseline and 4 hours | ||
Secondary | Change in PANSS-EC From Baseline | Baseline and 24 hours |
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