ID

25294

Descripción

Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits; ODM derived from: https://clinicaltrials.gov/show/NCT00487942

Link

https://clinicaltrials.gov/show/NCT00487942

Palabras clave

Versiones (1)
  1. 31/8/17 31/8/17 -
Subido en

31 de agosto de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00487942

Inglés

Eligibility Schizophrenia NCT00487942

1 formularios  
Criteria
Descripción

Criteria

the patient has a diagnosis of schizophrenia according to the dsm-iv-tr criteria as determined by the scid and has been clinically stable in a nonacute phase of their illness for at least 8 weeks prior to the baseline visit.
Descripción

Schizophrenia | Stable status Clinical

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0205210
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 olanzapine, oral risperidone, or paliperidone for at least 4 weeks prior to the screening visit. the patient is prepared to remain at these stable dosages for the duration of the study.
Descripción

Therapeutic procedure Schizophrenia | Olanzapine Dose Stable | Oral Risperidone Dose Stable | Paliperidone Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0036341
UMLS CUI [2,1]
C0171023
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C1319760
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0753678
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
the patient is a man or woman 18 through 60 years of age.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
the patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator on the basis of medical and psychiatric history, medical examination, ecg, serum chemistry, hematology, and urinalysis.
Descripción

Good health | Exception Schizophrenia | Medical History | Psychiatric History | Medical Examination | Electrocardiography | Serum chemistry test | Hematology | Urinalysis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0748059
UMLS CUI [5]
C0582103
UMLS CUI [6]
C1623258
UMLS CUI [7]
C0236613
UMLS CUI [8]
C0200627
UMLS CUI [9]
C0042014
women of childbearing potential 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.
Descripción

Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
the patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
key exclusion criteria:
Descripción

Exclusion Criteria Main

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
the patient has any axis i disorder, including schizoaffective disorder and sleep disorders, apart from schizophrenia, and nicotine dependence.
Descripción

Axis I diagnosis | Schizoaffective Disorder | Sleep Disorders | Exception Schizophrenia | Exception Nicotine Dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0851578
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0036341
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0028043
the patient has tardive dyskinesia or any other clinically significant movement disorder.
Descripción

Tardive Dyskinesia | Movement Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2]
C0026650
the patient has any clinically significant uncontrolled medical (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition.
Descripción

Medical condition Uncontrolled | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Surgery Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5,1]
C0038895
UMLS CUI [5,2]
C0205318
the patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
Descripción

modafinil | armodafinil | Hypersensitivity Investigational New Drugs Ingredient

Tipo de datos

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
the patient is a pregnant or lactating woman. (any woman becoming pregnant during the study will be withdrawn from the study.)
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Schizophrenia NCT00487942

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Schizophrenia | Stable status Clinical
Item
the patient has a diagnosis of schizophrenia according to the dsm-iv-tr criteria as determined by the scid and has been clinically stable in a nonacute phase of their illness for at least 8 weeks prior to the baseline visit.
boolean
C0036341 (UMLS CUI [1])
C0205360 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
Therapeutic procedure Schizophrenia | Olanzapine Dose Stable | Oral Risperidone Dose Stable | Paliperidone Dose Stable
Item
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 olanzapine, oral risperidone, or paliperidone for at least 4 weeks prior to the screening visit. the patient is prepared to remain at these stable dosages for the duration of the study.
boolean
C0087111 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C0171023 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C1319760 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0753678 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Age
Item
the patient is a man or woman 18 through 60 years of age.
boolean
C0001779 (UMLS CUI [1])
Good health | Exception Schizophrenia | Medical History | Psychiatric History | Medical Examination | Electrocardiography | Serum chemistry test | Hematology | Urinalysis
Item
the patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator on the basis of medical and psychiatric history, medical examination, ecg, serum chemistry, hematology, and urinalysis.
boolean
C3813622 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3])
C0748059 (UMLS CUI [4])
C0582103 (UMLS CUI [5])
C1623258 (UMLS CUI [6])
C0236613 (UMLS CUI [7])
C0200627 (UMLS CUI [8])
C0042014 (UMLS CUI [9])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential 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.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Protocol Compliance
Item
the patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.
boolean
C0525058 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Axis I diagnosis | Schizoaffective Disorder | Sleep Disorders | Exception Schizophrenia | Exception Nicotine Dependence
Item
the patient has any axis i disorder, including schizoaffective disorder and sleep disorders, apart from schizophrenia, and nicotine dependence.
boolean
C0270287 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0851578 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0036341 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0028043 (UMLS CUI [5,2])
Tardive Dyskinesia | Movement Disorders
Item
the patient has tardive dyskinesia or any other clinically significant movement disorder.
boolean
C0686347 (UMLS CUI [1])
C0026650 (UMLS CUI [2])
Medical condition Uncontrolled | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Surgery Uncontrolled
Item
the patient has any clinically significant uncontrolled medical (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition.
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0038895 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
modafinil | armodafinil | Hypersensitivity Investigational New Drugs 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])
Pregnancy | Breast Feeding
Item
the patient is a pregnant or lactating woman. (any woman becoming pregnant during the study will be withdrawn from the study.)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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