ID

19252

Description

A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia.; ODM derived from: https://clinicaltrials.gov/show/NCT00077727

Link

https://clinicaltrials.gov/show/NCT00077727

Keywords

Versions (1)
  1. 12/15/16 12/15/16 -
Uploaded on

December 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00077727

English

Eligibility Schizophrenia NCT00077727

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of schizophrenia present for at least 1 year, and has not returned to his/her level of functioning before the disease, with a brief psychiatric rating scale score of 30 to 60 (inclusive), and cognitive impairment as determined by scores from neuropsychological tests and subtests
Description

Schizophrenia disease length Brief Psychiatric Rating Scale | Impaired cognition Neuropsychological Tests Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
UMLS CUI [1,3]
C0029941
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0027902
UMLS CUI [2,3]
C0449820
nicotine user with a minimum intake equivalent to 5 cigarettes per day
Description

Tobacco use Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
on a stable dose of allowed atypical antipsychotic medication (risperidone [either oral or consta], olanzapine, quetiapine, ziprasidone, or aripiprazole) alone or in combination, for at least 30 days before screening, and deemed able to continue on the same dose
Description

Atypical antipsychotic Dose Stable | Risperidone Oral Product | Risperidone | olanzapine | quetiapine | ziprasidone | aripiprazole

Data type

boolean

Alias
UMLS CUI [1,1]
C1276996
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C1319760
UMLS CUI [3]
C0073393
UMLS CUI [4]
C0171023
UMLS CUI [5]
C0123091
UMLS CUI [6]
C0380393
UMLS CUI [7]
C0299792
women patients must be postmenopausal, surgically sterile, or using appropriate contraception before entry and throughout the study, and have a negative pregnancy test at screening
Description

Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Gender Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0427780
able to read, write, and understand english, and has no limitations in communication skills that would prevent him/her from completing the cognitive tests used in this study.
Description

Able to read English Language | Able to write English Language | Comprehension English Language | Communication skills Adequate | Tests Cognitive Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0376245
UMLS CUI [4,1]
C0870313
UMLS CUI [4,2]
C0205411
UMLS CUI [5,1]
C0392366
UMLS CUI [5,2]
C1516691
UMLS CUI [5,3]
C0205197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously enrolled in a galantamine hydrobromide study
Description

Study Subject Participation Status | galantamine hydrobromide Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0949312
UMLS CUI [2,2]
C0008976
any clinically significant uncontrolled medical illness (such as peptic ulcer disease
Description

Illness Clinical Significance Uncontrolled | Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0030920
urinary tract obstruction
Description

Urinary tract obstruction

Data type

boolean

Alias
UMLS CUI [1]
C0178879
or neurologic, cardiac, hepatic, renal, metabolic, or endocrine disturbances)
Description

nervous system disorder | Heart Diseases | Liver diseases | Kidney Diseases | Metabolic Diseases | Endocrine System Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0025517
UMLS CUI [6]
C0014130
history of severe asthma
Description

Severe asthma

Data type

boolean

Alias
UMLS CUI [1]
C0581126
any history of epilepsy or convulsions, except for febrile convulsions during childhood
Description

Epilepsy | Convulsions | Febrile Convulsions Childhood

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C4048158
UMLS CUI [3,1]
C0009952
UMLS CUI [3,2]
C0231335
history of cancer within the past year, except for treated basal cell carcinoma, or any history of prolactin-dependent breast cancer
Description

Malignant Neoplasms | Basal cell carcinoma Treated | Breast Carcinoma Prolactin Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0033371
UMLS CUI [3,3]
C0851827
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Similar models

Eligibility Schizophrenia NCT00077727

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia disease length Brief Psychiatric Rating Scale | Impaired cognition Neuropsychological Tests Score
Item
diagnosis of schizophrenia present for at least 1 year, and has not returned to his/her level of functioning before the disease, with a brief psychiatric rating scale score of 30 to 60 (inclusive), and cognitive impairment as determined by scores from neuropsychological tests and subtests
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0029941 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2,1])
C0027902 (UMLS CUI [2,2])
C0449820 (UMLS CUI [2,3])
Tobacco use Number of cigarettes per day
Item
nicotine user with a minimum intake equivalent to 5 cigarettes per day
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Atypical antipsychotic Dose Stable | Risperidone Oral Product | Risperidone | olanzapine | quetiapine | ziprasidone | aripiprazole
Item
on a stable dose of allowed atypical antipsychotic medication (risperidone [either oral or consta], olanzapine, quetiapine, ziprasidone, or aripiprazole) alone or in combination, for at least 30 days before screening, and deemed able to continue on the same dose
boolean
C1276996 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1319760 (UMLS CUI [2])
C0073393 (UMLS CUI [3])
C0171023 (UMLS CUI [4])
C0123091 (UMLS CUI [5])
C0380393 (UMLS CUI [6])
C0299792 (UMLS CUI [7])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Gender Pregnancy test negative
Item
women patients must be postmenopausal, surgically sterile, or using appropriate contraception before entry and throughout the study, and have a negative pregnancy test at screening
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Able to read English Language | Able to write English Language | Comprehension English Language | Communication skills Adequate | Tests Cognitive Completion
Item
able to read, write, and understand english, and has no limitations in communication skills that would prevent him/her from completing the cognitive tests used in this study.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
C0870313 (UMLS CUI [4,1])
C0205411 (UMLS CUI [4,2])
C0392366 (UMLS CUI [5,1])
C1516691 (UMLS CUI [5,2])
C0205197 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | galantamine hydrobromide Clinical Trial
Item
previously enrolled in a galantamine hydrobromide study
boolean
C2348568 (UMLS CUI [1])
C0949312 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Illness Clinical Significance Uncontrolled | Peptic Ulcer
Item
any clinically significant uncontrolled medical illness (such as peptic ulcer disease
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0030920 (UMLS CUI [2])
Urinary tract obstruction
Item
urinary tract obstruction
boolean
C0178879 (UMLS CUI [1])
nervous system disorder | Heart Diseases | Liver diseases | Kidney Diseases | Metabolic Diseases | Endocrine System Diseases
Item
or neurologic, cardiac, hepatic, renal, metabolic, or endocrine disturbances)
boolean
C0027765 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
Severe asthma
Item
history of severe asthma
boolean
C0581126 (UMLS CUI [1])
Epilepsy | Convulsions | Febrile Convulsions Childhood
Item
any history of epilepsy or convulsions, except for febrile convulsions during childhood
boolean
C0014544 (UMLS CUI [1])
C4048158 (UMLS CUI [2])
C0009952 (UMLS CUI [3,1])
C0231335 (UMLS CUI [3,2])
Malignant Neoplasms | Basal cell carcinoma Treated | Breast Carcinoma Prolactin Dependent
Item
history of cancer within the past year, except for treated basal cell carcinoma, or any history of prolactin-dependent breast cancer
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0678222 (UMLS CUI [3,1])
C0033371 (UMLS CUI [3,2])
C0851827 (UMLS CUI [3,3])
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