Schizophrenia | Stable status Clinical | Illness Acute phase Absent
Item
the patient has a diagnosis of schizophrenia according to the dsm-iv-tr criteria and the patient has been clinically stable in a nonacute phase of their illness.
boolean
C0036341 (UMLS CUI [1])
C0205360 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0221423 (UMLS CUI [3,1])
C0439557 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Therapy Schizophrenia | olanzapine | Risperidone Oral Product | paliperidone | Antipsychotic Agents Dose Stable
Item
documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit.
boolean
C0087111 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C0171023 (UMLS CUI [2])
C1319760 (UMLS CUI [3])
C0753678 (UMLS CUI [4])
C0040615 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
Good health | Exception Schizophrenia
Item
the patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator.
boolean
C3813622 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Female Sterilization Absent | Postmenopausal state Absent | Contraception, Barrier | Vaginal Spermicides | Intrauterine Devices | Hormonal contraception | Contraceptives, Oral | Transdermal contraceptives | Contraceptive implant | Contraceptive injection | Sexual Abstinence Documented
Item
women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. acceptable methods of contraception include barrier method with spermicide, intrauterine device (iud), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0004764 (UMLS CUI [4])
C0087145 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C2985296 (UMLS CUI [7])
C0009905 (UMLS CUI [8])
C1456475 (UMLS CUI [9])
C1657106 (UMLS CUI [10])
C1656586 (UMLS CUI [11])
C0036899 (UMLS CUI [12,1])
C1301725 (UMLS CUI [12,2])
PANSS Symptoms Negative
Item
the patient has a panss negative symptom score of 15 or more at the screening and baseline visits.
boolean
C4086747 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Illness Moderate | Illness Severe | PANSS Symptoms Positive
Item
the patient has a severity rating of moderate or worse on any item of the panss positive symptom subscale.
boolean
C0221423 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4086747 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Axis I diagnosis | Schizoaffective Disorder | Exception Schizophrenia | Exception Nicotine Dependence | Axis II diagnosis Interferes with Completion of clinical trial
Item
the patient has any axis i disorder according to dsm-iv-tr criteria, including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any axis ii disorder that would interfere with the conduct of the study.
boolean
C0270287 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0036341 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0028043 (UMLS CUI [4,2])
C0270288 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2732579 (UMLS CUI [5,3])
Depressive Symptoms Moderate | Depressive Symptoms Severe | Depression scale Schizophrenia
Item
the patient has moderate to severe depressive symptoms, as indicated by the cdss.
boolean
C0086132 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086132 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0679604 (UMLS CUI [3,1])
C0036341 (UMLS CUI [3,2])
Feeling suicidal | At risk for deliberate self harm | Suicide attempt
Item
the patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
boolean
C0424000 (UMLS CUI [1])
C1276053 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
Tardive Dyskinesia | Akathisia | Extrapyramidal symptoms Moderate | Extrapyramidal symptoms Severe | Movement Disorders
Item
the patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder.
boolean
C0686347 (UMLS CUI [1])
C0392156 (UMLS CUI [2])
C0234133 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0234133 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0026650 (UMLS CUI [5])
Adverse reaction to drug Cutaneous | Drug Allergy Cutaneous | Hypersensitivity | Multiple allergies
Item
the patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies.
boolean
C0041755 (UMLS CUI [1,1])
C0221912 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2,1])
C0221912 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3])
C0740281 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
the patient is a pregnant or lactating woman.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
modafinil | armodafinil | Hypersensitivity Investigational New Drug Ingredient
Item
the patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
boolean
C0066677 (UMLS CUI [1])
C1701455 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1550600 (UMLS CUI [3,3])