ID

39172

Description

A Study to Evaluate the Efficacy and Safety of Add-on Therapy of Wuling Capsule in Epilepsy Patients With Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01125241

Link

https://clinicaltrials.gov/show/NCT01125241

Keywords

Versions (1)
  1. 12/7/19 12/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Epilepsy NCT01125241

English

Eligibility Epilepsy NCT01125241

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Epilepsy NCT01125241
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects for this study will meet the following criteria:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. age greater than or equal to 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. must be in accordance with the diagnostic criteria of epilepsy and have taken antiepileptic drugs regularly at least for 6 months, which will not be changed recently. the duration to the latest seizure must be longer than 24 hours.
Description

Epilepsy | Antiepileptic Agents Regular | Seizure

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0003299
UMLS CUI [2,2]
C0205272
UMLS CUI [3]
C0036572
3. score of a 17 item hamilton depression is greater than or equal to 17 and depressive symptoms have lasted for at least 2 weeks.
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification | Depressive Symptoms Duration

Data type

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2,1]
C0086132
UMLS CUI [2,2]
C0449238
4. haven't taken any anti-anxiety, anti-depressant and anti-psychotic drugs in recent 2 weeks.
Description

Anti-Anxiety Agents Absent | Antidepressive Agents Absent | Antipsychotic Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0040616
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C0332197
5. must sign the informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. now accepting or have accepted other drugs clinical trial in the last month.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
2. history of serious psychiatric illness other than depression.
Description

Serious mental illness | Exception Depressive disorder

Data type

boolean

Alias
UMLS CUI [1]
C3841614
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011581
3. having suicide ideas or suicide behaviors.
Description

Suicidal ideas | Suicidal behavior

Data type

boolean

Alias
UMLS CUI [1]
C0850335
UMLS CUI [2]
C1760428
4. progressive illness of central nervous system, such as degenerative disease or tumor.
Description

CNS disorder Progressive | Degenerative Diseases, Central Nervous System | Central Nervous System Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0205329
UMLS CUI [2]
C0270715
UMLS CUI [3]
C0085136
5. history of serious cardiac or pulmonary disease, hepatic and renal dysfunction, and malignant tumors.
Description

Heart Disease Serious | Lung disease Serious | Liver Dysfunction | Renal dysfunction | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0086565
UMLS CUI [4]
C3279454
UMLS CUI [5]
C0006826
6. the value of alt or ast is higher than 1.5 times normal range, or the number of white blood cells is less than 2500/ul, or the number of neutrophil granulocyte is less than 1000/ul.
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased | White Blood Cell Count procedure | Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0200633
7. during pregnant or lactation period.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. the person who is disabled or mentally disabled.
Description

Disabled Person | Mental handicap

Data type

boolean

Alias
UMLS CUI [1]
C0018576
UMLS CUI [2]
C1306341
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Similar models

Eligibility Epilepsy NCT01125241

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Epilepsy NCT01125241
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
subjects for this study will meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
1. age greater than or equal to 18 years.
boolean
C0001779 (UMLS CUI [1])
Epilepsy | Antiepileptic Agents Regular | Seizure
Item
2. must be in accordance with the diagnostic criteria of epilepsy and have taken antiepileptic drugs regularly at least for 6 months, which will not be changed recently. the duration to the latest seizure must be longer than 24 hours.
boolean
C0014544 (UMLS CUI [1])
C0003299 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0036572 (UMLS CUI [3])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Depressive Symptoms Duration
Item
3. score of a 17 item hamilton depression is greater than or equal to 17 and depressive symptoms have lasted for at least 2 weeks.
boolean
C3639712 (UMLS CUI [1])
C0086132 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Anti-Anxiety Agents Absent | Antidepressive Agents Absent | Antipsychotic Agents Absent
Item
4. haven't taken any anti-anxiety, anti-depressant and anti-psychotic drugs in recent 2 weeks.
boolean
C0040616 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0040615 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
5. must sign the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs
Item
1. now accepting or have accepted other drugs clinical trial in the last month.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Serious mental illness | Exception Depressive disorder
Item
2. history of serious psychiatric illness other than depression.
boolean
C3841614 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011581 (UMLS CUI [2,2])
Suicidal ideas | Suicidal behavior
Item
3. having suicide ideas or suicide behaviors.
boolean
C0850335 (UMLS CUI [1])
C1760428 (UMLS CUI [2])
CNS disorder Progressive | Degenerative Diseases, Central Nervous System | Central Nervous System Neoplasms
Item
4. progressive illness of central nervous system, such as degenerative disease or tumor.
boolean
C0007682 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0270715 (UMLS CUI [2])
C0085136 (UMLS CUI [3])
Heart Disease Serious | Lung disease Serious | Liver Dysfunction | Renal dysfunction | Malignant Neoplasms
Item
5. history of serious cardiac or pulmonary disease, hepatic and renal dysfunction, and malignant tumors.
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0086565 (UMLS CUI [3])
C3279454 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
Alanine aminotransferase increased | Aspartate aminotransferase increased | White Blood Cell Count procedure | Neutrophil count
Item
6. the value of alt or ast is higher than 1.5 times normal range, or the number of white blood cells is less than 2500/ul, or the number of neutrophil granulocyte is less than 1000/ul.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0200633 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
7. during pregnant or lactation period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disabled Person | Mental handicap
Item
8. the person who is disabled or mentally disabled.
boolean
C0018576 (UMLS CUI [1])
C1306341 (UMLS CUI [2])
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