Eligibility criteria
| Inclusion criteria | Exclusion criteria | |
| 1 | Male and female patients aged 18–65 years | Diagnosis of dementia |
| 2 | Patient (or legal representative) willing and able to provide written informed consent | Serious and unstable illnesses, including current hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischaemic heart disease and congestive heart failure), endocrinological, neurological (including stroke, transient ischaemic attack, subarachnoid bleeding, brain tumour, encephalopathy and meningitis) disease |
| 3 | Diagnosis of schizophrenia or bipolar disorder (according to DSM-IV-TR, DSM-V or ICD-10 criteria) | History of allergic reaction to loxapine or amoxapine |
| 4 | Ongoing agitation episode (mild or moderate) or previous agitation episode within the 6 months prior to screening managed in the hospital setting | Use of an investigational drug within 30 days before the current agitation episode |
| 5 | Previous treatment with inhaled loxapine with a positive outcome according to the CGI-I scale (CGI-I score of 1 or 2 at 2 hours after administration of inhaled loxapine), or an equivalent clinical evaluation at the discretion of the investigator, and no bronchospasm after previous administration of inhaled loxapine | Inability to self-administer the study medication, as judged by the investigator |
| 6 | No active respiratory disease such as acute respiratory signs/symptoms (eg, wheezing) or active airway disease (asthma, chronic obstructive pulmonary disease or emphysema) | |
| 7 | Patient and/or family member/caregiver able to: a. Understand and follow specific training for the administration of inhaled loxapine outside the hospital setting b. Identify/detect a respiratory problem c. Use of a bronchodilator if necessary | |
| 8 | A family member or other caregiver who: a. Is male or female b. Is ≤80 years old c. Can spend 3+ consecutive hours with the patient d. Has good physical and psychological health, without physical limitations e. Is able to read and write f. Is able to understand and follow the study procedures | |
| 9 | Medical record data available for the patient’s previous treatment with inhaled loxapine in the hospital setting | |
| 10 | For women of childbearing potential (not including females who are surgically sterile or postmenopausal with no menstruation during the previous 24 months), confirmation that they: a. Are non-lactating b. Are non-pregnant (negative pregnancy test result at baseline) c. Agree to use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study |
First patient in was on 8 September 2016.
Last patient out is predicted to be in September 2018.
CGI-I, Clinical Global Impression-Improvement; DMS-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision; DMS-V, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.