Comparison of treatment with inhaled loxapine and an injected drug to treat patients with schizophrenia or bipolar disorder and who are seriously agitated

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 468

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)-5 criteria for schizophrenia or bipolar disorder I.
3. Patients judged to be clinically agitated at baseline with a value of >/= 4 and < 6 (moderately, markedly agitated) out of the 7 items on the CGI-S scale.
4. Written informed consent from patients with documented adequate consent capacity per the Investigator's judgement.
5. Patients in good general health prior to study participation as judged by the Investigator and stated in the patient's record.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 468
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with agitation caused primarily by acute intoxication (as per Investigator's judgment).
2. Patients with acute alcohol or psychoactive drugs intoxication/withdrawal symptoms incompatible with their participation in the study as judged by the Investigator.
3. Patients judged to be at serious risk for suicide as per the Investigator's judgement.
4. Patients treated with benzodiazepines or other hypnotics or oral or short-acting IM antipsychotics within 4 hours prior to study drug administration (however, those patients may be subsequently reassessed for inclusion).
5. Patients treated with injectable depot neuroleptics or long-acting second generation antipsychotics within 1 dose interval prior to study drug administration (however, those patients may be subsequently reassessed for inclusion).
6. Patients with a history of allergy or intolerance to loxapine or amoxapine and/or aripiprazole.
7. Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding or inpatients who previously had a positive serum pregnancy test upon admission.
8. Patients with previous laboratory or electrocardiogram abnormalities considered relevant by the Investigator that may have clinical implications for the patient's participation in the study.
9. Patients with significant hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic or hematologic disease.
10. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease).
11. Patients who received an investigational drug within 30 days prior to screening.
12. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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