Schizophrenia disease length
Item
double-blind phase: dsm-iv diagnosis of schizophrenia for at least 1 year
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
schizophrenic episode Positive and negative syndrome scale
Item
experiencing an acute episode, with a total panss score at screening between 70 and 120
boolean
C1396838 (UMLS CUI [1,1])
C0451383 (UMLS CUI [1,2])
HOSPITALIZATION VOLUNTARY Duration Agreement
Item
agree to voluntary hospitalization for a minimum of 14 days
boolean
C0745044 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
Questionnaires Self-Administered Completion
Item
willing and able to fill out self-administered questionnaires
boolean
C0034394 (UMLS CUI [1,1])
C1519231 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Pharmaceutical Preparations Self-Administered Compliance behavior
Item
must be able to be compliant with self-administration of medication, or have consistent help/support available.
boolean
C0013227 (UMLS CUI [1,1])
C1519231 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Therapeutic procedure Double-Blind Method Complete | Therapeutic procedure Discontinued Lack of Efficacy
Item
open-label phase: have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy
boolean
C0087111 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0235828 (UMLS CUI [2,3])
Open Label Treatment Agreement
Item
patient and investigator must agree that open-label treatment is in the best interest of the patient.
boolean
C3640652 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Axis I diagnosis | Schizophrenia
Item
double-blind phase: dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
dsm-iv diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Tardive Dyskinesia | Neuroleptic Malignant Syndrome
Item
history of tardive dyskinesia or neuroleptic malignant syndrome (nms)
boolean
C0686347 (UMLS CUI [1])
C0027849 (UMLS CUI [2])
Gastrointestinal stenosis Pathologic Pre-existing Severe | Gastrointestinal stenosis Iatrogenic Pre-existing Severe
Item
history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
boolean
C0521587 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0521587 (UMLS CUI [2,1])
C0439669 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
Antipsychotic Agents Quantity | Poor response to treatment
Item
previous history of a lack of response (2 adequate trials) to any antipsychotic
boolean
C0040615 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [2])
Suicidal behavior Risk Significant | Physical aggression Risk Significant | At risk for suicide Significant | At risk for violence Significant
Item
significant risk of suicidal or violent behavior. open-label extension: patients believed by the investigator to be at significant risk for suicidal or violent behavior
boolean
C1760428 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0424323 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0563664 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0231418 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
Injection of depot antipsychotic agent
Item
received an injection of a depot antipsychotic since entry into the preceding double-blind phase.
boolean
C2585377 (UMLS CUI [1])