Male and female patients between the ages of 18-65 years, inclusive
Patients (or legal representative) willing and able to provide written Informed Consent Form.
Psychiatric patients already diagnosed of schizophrenia or bipolar disorder, according to the Diagnostic and Statistical Manual of Mental Disorders- IV, Diagnostic and Statistical Manual of Mental Disorders- V or International Code of Disease criteria.
Patients with an on-going agitation episode, or with a previous one within the 6 months prior to screening, attended and managed in the hospital setting.
Previously treated with ADASUVE® with a positive outcome (responders) according to (CGI-I) scale (defined as having a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)
Patients free of active respiratory disease such as acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (asthma, chronic obstructive pulmonary disease or emphysema).
Requirement of family or other caregiver support at study investigator criteria (defined as a patient's relative or caregiver (male or female) = 80 year old, who spend = 3 consecutive hours with patient, with good physical and psychological health status and without physical limitations, reading and writing educational level and able to understand and follow the study procedures).
Availability of patient's medical records data about the previous treatment with ADASUVE® at hospital setting.
If a female is of childbearing potential and sexually active (except if female is surgically sterile or post-menopausal with history of no menses for at least 24 months), patient must be non-lactating and non-pregnant (with a negative pregnancy test result at baseline visit) and have to agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study.

NCT02525991_inc_T1
Person
Male
NCT02525991_inc_T2
Person
female
NCT02525991_inc_T3
Person
ages
NCT02525991_inc_T4
Value
18-65 years
NCT02525991_inc_T6
Condition
schizophrenia
NCT02525991_inc_T7
Condition
bipolar disorder
NCT02525991_inc_T8
Measurement
Diagnostic and Statistical Manual of Mental Disorders- IV
NCT02525991_inc_T9
Measurement
Diagnostic and Statistical Manual of Mental Disorders- V
NCT02525991_inc_T10
Measurement
International Code of Disease criteria
NCT02525991_inc_T11
Scope
schizophrenia or bipolar disorder,
NCT02525991_inc_T12
Scope
Diagnostic and Statistical Manual of Mental Disorders- IV, Diagnostic and Statistical Manual of Mental Disorders- V or International Code of Disease criteria
NCT02525991_inc_T13
Condition
agitation episode
NCT02525991_inc_T14
Temporal
within the 6 months prior to screening
NCT02525991_inc_T15
Reference_point
screening
NCT02525991_inc_T16
Drug
ADASUVE
NCT02525991_inc_T17
Measurement
CGI-I score
NCT02525991_inc_T18
Value
1 or 2
NCT02525991_inc_T19
Temporal
2 hours after administration of the inhalation)
NCT02525991_inc_T20
Reference_point
administration of the inhalation)
NCT02525991_inc_T21
Negation
free
NCT02525991_inc_T22
Condition
respiratory disease
NCT02525991_inc_T23
Qualifier
active
NCT02525991_inc_T24
Condition
acute respiratory signs
NCT02525991_inc_T25
Condition
 respiratory sig oms (e.g
NCT02525991_inc_T26
Condition
wheezing
NCT02525991_inc_T27
Condition
airways disease
NCT02525991_inc_T28
Qualifier
active
NCT02525991_inc_T29
Condition
asthma
NCT02525991_inc_T30
Condition
chronic obstructive pulmonary disease
NCT02525991_inc_T31
Condition
emphysema
NCT02525991_inc_T32
Scope
asthma, chronic obstructive pulmonary disease or emphysema
NCT02525991_inc_T33
Scope
acute respiratory signs/symptoms (e.g., wheezing)