ID

19368

Description

Schizophrenia, Related Troubles and Glutathione: Clinical Trial. Effects of Oral Administration of N-Acetylcysteine (NAC) on the Brain Glutathione Level and on the Symptoms of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01506765

Link

https://clinicaltrials.gov/show/NCT01506765

Keywords

Versions (1)
  1. 12/22/16 12/22/16 -
Uploaded on

December 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01506765

English

Eligibility Schizophrenia NCT01506765

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients (male or female, aged 18 to 65 years, qi>70) meeting the dsm-iv criteria (established by a senior psychiatrist) for schizophrenia and have the capacity to consent to the study. the study population include both inpatients and outpatients who are currently taking at least one of the following:olanzapine, clozapine, haloperidol, risperidone, flupenthixol, or fluphenazine. the following guidelines have been established for potential medication changes that patients may undergo during the course of the trial.
Description

Age | Intelligence quotient | Schizophrenia | Informed Consent | inpatient | Outpatients | olanzapine | Clozapine | Haloperidol | Risperidone | Flupenthixol | Fluphenazine

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0456149
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0021430
UMLS CUI [5]
C0021562
UMLS CUI [6]
C0029921
UMLS CUI [7]
C0171023
UMLS CUI [8]
C0009079
UMLS CUI [9]
C0018546
UMLS CUI [10]
C0073393
UMLS CUI [11]
C0016367
UMLS CUI [12]
C0016368
dose changes to existing medication (either increases or decreases in dose) will be accepted and participants will be allowed to continue with the trial.
Description

Medication dose changed

Data type

boolean

Alias
UMLS CUI [1]
C1608430
a change in primary antipsychotics from one medication to another will require participants to withdrawn from the study.
Description

Antipsychotic Agents Primary Change | Clinical Trial Withdrawal Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C2349954
UMLS CUI [2,3]
C0686904
an addiction of another antipsychotic, secondary to the existing antipsychotic treatment (primary antipsychotic) will be acceptable providing that there isn't a complete change from one antipsychotic to another.
Description

Antipsychotic drug therapy | Antipsychotic Agent Secondary Addiction

Data type

boolean

Alias
UMLS CUI [1]
C1319421
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0085281
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
acute psychotic state, preventing the patient cooperation
Description

Psychotic state Preventing Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0459435
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1321605
co-morbidity with drug dependency
Description

Comorbidity | Drug Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C1510472
organic cerebral disease, major somatic diseases
Description

Organic brain disorder | Disease Major

Data type

boolean

Alias
UMLS CUI [1]
C4062280
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205164
abnormal renal, hepatic, thyroid or hematological findings
Description

Abnormal renal function | Liver Dysfunction | Thyroid function tests abnormal | Hematologic function Abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0476414
UMLS CUI [4,1]
C0221130
UMLS CUI [4,2]
C0205161
treatment with a regulator of mood(lithium, valproate, topiramate, lamotrigine et carbamazepine)
Description

Mood regulation | Lithium | Valproate | topiramate | lamotrigine | Carbamazepine

Data type

boolean

Alias
UMLS CUI [1,1]
C0026516
UMLS CUI [1,2]
C0598959
UMLS CUI [2]
C0023870
UMLS CUI [3]
C0080356
UMLS CUI [4]
C0076829
UMLS CUI [5]
C0064636
UMLS CUI [6]
C0006949
allergy to nac
Description

Hypersensitivity Acetylcysteine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001047
treatment with antioxidants
Description

Antioxidants

Data type

boolean

Alias
UMLS CUI [1]
C0003402
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Similar models

Eligibility Schizophrenia NCT01506765

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Intelligence quotient | Schizophrenia | Informed Consent | inpatient | Outpatients | olanzapine | Clozapine | Haloperidol | Risperidone | Flupenthixol | Fluphenazine
Item
patients (male or female, aged 18 to 65 years, qi>70) meeting the dsm-iv criteria (established by a senior psychiatrist) for schizophrenia and have the capacity to consent to the study. the study population include both inpatients and outpatients who are currently taking at least one of the following:olanzapine, clozapine, haloperidol, risperidone, flupenthixol, or fluphenazine. the following guidelines have been established for potential medication changes that patients may undergo during the course of the trial.
boolean
C0001779 (UMLS CUI [1])
C0456149 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0021430 (UMLS CUI [4])
C0021562 (UMLS CUI [5])
C0029921 (UMLS CUI [6])
C0171023 (UMLS CUI [7])
C0009079 (UMLS CUI [8])
C0018546 (UMLS CUI [9])
C0073393 (UMLS CUI [10])
C0016367 (UMLS CUI [11])
C0016368 (UMLS CUI [12])
Medication dose changed
Item
dose changes to existing medication (either increases or decreases in dose) will be accepted and participants will be allowed to continue with the trial.
boolean
C1608430 (UMLS CUI [1])
Antipsychotic Agents Primary Change | Clinical Trial Withdrawal Patient need for
Item
a change in primary antipsychotics from one medication to another will require participants to withdrawn from the study.
boolean
C0040615 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Antipsychotic drug therapy | Antipsychotic Agent Secondary Addiction
Item
an addiction of another antipsychotic, secondary to the existing antipsychotic treatment (primary antipsychotic) will be acceptable providing that there isn't a complete change from one antipsychotic to another.
boolean
C1319421 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0085281 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Psychotic state Preventing Compliance behavior
Item
acute psychotic state, preventing the patient cooperation
boolean
C0459435 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Comorbidity | Drug Dependence
Item
co-morbidity with drug dependency
boolean
C0009488 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
Organic brain disorder | Disease Major
Item
organic cerebral disease, major somatic diseases
boolean
C4062280 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
Abnormal renal function | Liver Dysfunction | Thyroid function tests abnormal | Hematologic function Abnormal
Item
abnormal renal, hepatic, thyroid or hematological findings
boolean
C0151746 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0476414 (UMLS CUI [3])
C0221130 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
Mood regulation | Lithium | Valproate | topiramate | lamotrigine | Carbamazepine
Item
treatment with a regulator of mood(lithium, valproate, topiramate, lamotrigine et carbamazepine)
boolean
C0026516 (UMLS CUI [1,1])
C0598959 (UMLS CUI [1,2])
C0023870 (UMLS CUI [2])
C0080356 (UMLS CUI [3])
C0076829 (UMLS CUI [4])
C0064636 (UMLS CUI [5])
C0006949 (UMLS CUI [6])
Hypersensitivity Acetylcysteine
Item
allergy to nac
boolean
C0020517 (UMLS CUI [1,1])
C0001047 (UMLS CUI [1,2])
Antioxidants
Item
treatment with antioxidants
boolean
C0003402 (UMLS CUI [1])
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