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

Phase 1

• Conditions: SCHIZOPHRENIA AND BIPOLAR DISORDER; MedDRA version: 19.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 19.0Level: PTClassification code 10057667Term: Bipolar disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-000456-29-CZ
• Lead Sponsor: Ferrer Internacional, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-10
• Last Update Posted: 31 January 2017

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 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 1 hour prior to study drug administration (however, those patients may be subsequently reassessed for inclusion).
5.Patients with a history of allergy or intolerance to loxapine or amoxapine and/or aripiprazole.
6. 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.
7. 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.
8. Patients with significant hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic or hematologic disease.
9. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease).
10. Patients who received an investigational drug within 30 days prior to screening.
11. 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