Age
Item
1. male and female patients between the ages of 18 to 65 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder
Item
2. patients who have met dsm-iv criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder.
boolean
C0036341 (UMLS CUI [1])
C0036358 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
Agitation
Item
3. patients who are judged to be clinically agitated at baseline with a total score of ≥
boolean
C0085631 (UMLS CUI [1])
PANSS - Poor Impulse Control | PANSS - Tension | PANSS - Hostility | PANSS - Uncooperativeness | PANSS - Excitement
Item
14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the panss excited component (pec).
boolean
C4086704 (UMLS CUI [1])
C4086709 (UMLS CUI [2])
C4086697 (UMLS CUI [3])
C4086710 (UMLS CUI [4])
C4086693 (UMLS CUI [5])
PANSS - Excitement
Item
4. patients who have a value of ≥ 4 (out of 7) on at least 1 of the 5 items on the panss excited component.
boolean
C4086693 (UMLS CUI [1])
Able to read English Language | Comprehension English Language | Informed Consent
Item
5. patients who read and understand english and provide written informed consent.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
General health good | Medical History | Physical Examination | 12 lead ECG | Blood Chemical Analysis | Hematology procedure | Urinalysis
Item
6. patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ecg, blood chemistry profile, hematology, urinalysis and in the opinion of the principal investigator.
boolean
C1277245 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0430456 (UMLS CUI [4])
C0005774 (UMLS CUI [5])
C0200627 (UMLS CUI [6])
C0042014 (UMLS CUI [7])
Sexually active Contraceptive methods | Childbearing Potential Contraceptive methods | Partner Childbearing Potential Contraceptive methods | Sexual Abstinence | Contraceptives, Oral | Contraceptive Patch | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices | Female Condoms | Spermicidal foam/jelly/cream/film/suppository | Female Sterilization | Progestin-containing Intrauterine Device | Rhythm method Excluded | Withdrawal Excluded
Item
7. female participants, if of child-bearing potential and sexually active, and male participants, if sexually active with a partner of child-bearing potential, who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study. medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (iud), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization and progestin implant or injection. prohibited methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.
boolean
C0241028 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0036899 (UMLS CUI [4])
C0009905 (UMLS CUI [5])
C2985284 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
C0221829 (UMLS CUI [10])
C3843415 (UMLS CUI [11])
C0015787 (UMLS CUI [12])
C2917409 (UMLS CUI [13])
C0035513 (UMLS CUI [14,1])
C2828389 (UMLS CUI [14,2])
C3812880 (UMLS CUI [15,1])
C2828389 (UMLS CUI [15,2])
Agitation caused by Intoxication | Drugs, Non-Prescription | Urine screening
Item
1. patients with agitation caused by acute intoxication must be excluded. positive identification of non-prescription drugs during urine screening excludes the subject.
boolean
C0085631 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0728899 (UMLS CUI [1,3])
C0013231 (UMLS CUI [2])
C0595946 (UMLS CUI [3])
Benzodiazepines | Hypnotics | Antipsychotic Agents Oral | Antipsychotic Agents Intramuscular Active short-term
Item
2. patients treated with benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotics within 4 hours prior to study drug administration must be excluded.
boolean
C0005064 (UMLS CUI [1])
C0020591 (UMLS CUI [2])
C0040615 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0040615 (UMLS CUI [4,1])
C1556154 (UMLS CUI [4,2])
C0205177 (UMLS CUI [4,3])
C0443303 (UMLS CUI [4,4])
Neuroleptics Depot Preparations Injectable
Item
3. patients treated with injectable depot neuroleptics within one dose interval prior to study drug administration must be excluded.
boolean
C0040615 (UMLS CUI [1,1])
C0086129 (UMLS CUI [1,2])
C0086466 (UMLS CUI [1,3])
Loxapine allergy | Amoxapine allergy
Item
4. patients with a history of allergic reactions to loxapine or amoxapine must be excluded.
boolean
C0570835 (UMLS CUI [1])
C0570749 (UMLS CUI [2])
Gender Pregnancy test positive | Breast Feeding
Item
5. female patients who have a positive pregnancy test at screening or are breastfeeding must be excluded.
boolean
C0079399 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
Parkinson Disease | Hydrocephalus | Epilepsy | Craniocerebral Trauma
Item
6. patients who have parkinson's disease, hydrocephalus, seizure disorder, or history of significant head trauma must be excluded.
boolean
C0030567 (UMLS CUI [1])
C0020255 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0018674 (UMLS CUI [4])
Laboratory test result abnormal Effect Study Subject Participation Status | ECG abnormality Effect Study Subject Participation Status
Item
7. patients with laboratory or ecg abnormalities considered clinically significant by the investigator or qualified designee that would have clinical implications for the patient's participation in the study must be excluded.
boolean
C0438215 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1832603 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Illness Serious | Illness Unstable | Liver diseases | Kidney Diseases | Gastroenterology Disease | Respiration Disorders | Cardiovascular Diseases | Myocardial Ischemia | Congestive heart failure | Endocrine System Diseases | nervous system disorder | Cerebrovascular accident | Transient Ischemic Attack | Subarachnoid Hemorrhage | Brain Neoplasms | Encephalopathy | Meningitis | Hematological Disease
Item
8. patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis), or hematologic disease must be excluded.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0017163 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0035204 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0151744 (UMLS CUI [8])
C0018802 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0027765 (UMLS CUI [11])
C0038454 (UMLS CUI [12])
C0007787 (UMLS CUI [13])
C0038525 (UMLS CUI [14])
C0006118 (UMLS CUI [15])
C0085584 (UMLS CUI [16])
C0025289 (UMLS CUI [17])
C0018939 (UMLS CUI [18])
Lung disease Excludes Adasuve | Chronic pulmonary disease | Asthma | Bronchitis | Pulmonary Emphysema
Item
9. patients who have a history of acute or chronic pulmonary disease that precludes administration of staccato loxapine (asthma, bronchitis, emphysema) must be excluded.
boolean
C0024115 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3530455 (UMLS CUI [1,3])
C0810290 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0006277 (UMLS CUI [4])
C0034067 (UMLS CUI [5])
Investigational New Drugs Before Episode of Agitation
Item
10. patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
boolean
C0013230 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C0085631 (UMLS CUI [1,4])
Loxapine | Patient Inappropriate | Inhalation Device Use Unable
Item
11. patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving loxapine, or unable to use the inhalation device, must be excluded.
boolean
C0024056 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0021455 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])