ID

32118

Beschreibung

Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00772005

Link

https://clinicaltrials.gov/show/NCT00772005

Stichworte

Versionen (1)
  1. 19.10.18 19.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

19. Oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00772005

Englisch

Eligibility Schizophrenia NCT00772005

1 Formulare  
Criteria
Beschreibung

Criteria

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.
Beschreibung

Schizophrenia | Stable status Clinical | Illness Acute phase Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0205210
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0439557
UMLS CUI [3,3]
C0332197
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.
Beschreibung

Therapy Schizophrenia | olanzapine | Risperidone Oral Product | paliperidone | Antipsychotic Agents Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0036341
UMLS CUI [2]
C0171023
UMLS CUI [3]
C1319760
UMLS CUI [4]
C0753678
UMLS CUI [5,1]
C0040615
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
the patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator.
Beschreibung

Good health | Exception Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0015787
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0087145
UMLS CUI [6]
C0021900
UMLS CUI [7]
C2985296
UMLS CUI [8]
C0009905
UMLS CUI [9]
C1456475
UMLS CUI [10]
C1657106
UMLS CUI [11]
C1656586
UMLS CUI [12,1]
C0036899
UMLS CUI [12,2]
C1301725
the patient has a panss negative symptom score of 15 or more at the screening and baseline visits.
Beschreibung

PANSS Symptoms Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1513916
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
the patient has a severity rating of moderate or worse on any item of the panss positive symptom subscale.
Beschreibung

Illness Moderate | Illness Severe | PANSS Symptoms Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C4086747
UMLS CUI [3,2]
C1457887
UMLS CUI [3,3]
C1514241
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.
Beschreibung

Axis I diagnosis | Schizoaffective Disorder | Exception Schizophrenia | Exception Nicotine Dependence | Axis II diagnosis Interferes with Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0036337
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0036341
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0028043
UMLS CUI [5,1]
C0270288
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2732579
the patient has moderate to severe depressive symptoms, as indicated by the cdss.
Beschreibung

Depressive Symptoms Moderate | Depressive Symptoms Severe | Depression scale Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086132
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0679604
UMLS CUI [3,2]
C0036341
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.
Beschreibung

Feeling suicidal | At risk for deliberate self harm | Suicide attempt

Datentyp

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C1276053
UMLS CUI [3]
C0038663
the patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder.
Beschreibung

Tardive Dyskinesia | Akathisia | Extrapyramidal symptoms Moderate | Extrapyramidal symptoms Severe | Movement Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2]
C0392156
UMLS CUI [3,1]
C0234133
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C0234133
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0026650
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.
Beschreibung

Adverse reaction to drug Cutaneous | Drug Allergy Cutaneous | Hypersensitivity | Multiple allergies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0221912
UMLS CUI [2,1]
C0013182
UMLS CUI [2,2]
C0221912
UMLS CUI [3]
C0020517
UMLS CUI [4]
C0740281
the patient is a pregnant or lactating woman.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
the patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
Beschreibung

modafinil | armodafinil | Hypersensitivity Investigational New Drug Ingredient

Datentyp

boolean

Alias
UMLS CUI [1]
C0066677
UMLS CUI [2]
C1701455
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C1550600
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Ähnliche Modelle

Eligibility Schizophrenia NCT00772005

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
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])
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