ID

17087

Description

Study Of 323U66 SR In Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00135512

Link

https://clinicaltrials.gov/show/NCT00135512

Keywords

Versions (1)
  1. 8/24/16 8/24/16 -
Uploaded on

August 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Depressive Disorder NCT00135512

English

Eligibility Depressive Disorder NCT00135512

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
met dsm-iv-tr criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.
Description

Major Depressive Disorder | Single major depressive episode

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0024517
must give a written informed consent. but if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
Description

Informed Consent | Age | Informed Consent Proxy

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0600420
must have rating scores as outlined.
Description

Global assessment of functioning

Data type

boolean

Alias
UMLS CUI [1]
C0561904
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or past history of seizure disorder or brain injury.
Description

Epilepsy | Brain Injury

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0270611
current or past history of anorexia or bulimia nervosa.
Description

Anorexia Nervosa | Bulimia Nervosa

Data type

boolean

Alias
UMLS CUI [1]
C0003125
UMLS CUI [2]
C2267227
history of manic episode.
Description

Manic episode

Data type

boolean

Alias
UMLS CUI [1]
C0349208
past or current dsm- iv-tr diagnosis of schizophrenia or other psychotic disorder.
Description

Schizophrenia | Psychotic Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0033975
diagnosis of substance abuse (alcohol or drug) by the dsm-iv-tr criteria.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
pregnant, possibly pregnant or lactating.
Description

Pregnancy | Pregnancy Possible | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332149
UMLS CUI [3]
C0006147
must not be suicidal.
Description

Suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0438696
blood pressure of sbp>160mmhg, dbp>100mmhg.
Description

Blood Pressure | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
history or complication of cancer or malignant tumour.
Description

cancer complication | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0596237
UMLS CUI [2]
C0006826
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Similar models

Eligibility Depressive Disorder NCT00135512

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder | Single major depressive episode
Item
met dsm-iv-tr criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.
boolean
C1269683 (UMLS CUI [1])
C0024517 (UMLS CUI [2])
Informed Consent | Age | Informed Consent Proxy
Item
must give a written informed consent. but if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
boolean
C0021430 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C0600420 (UMLS CUI [3,2])
Global assessment of functioning
Item
must have rating scores as outlined.
boolean
C0561904 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Epilepsy | Brain Injury
Item
current or past history of seizure disorder or brain injury.
boolean
C0014544 (UMLS CUI [1])
C0270611 (UMLS CUI [2])
Anorexia Nervosa | Bulimia Nervosa
Item
current or past history of anorexia or bulimia nervosa.
boolean
C0003125 (UMLS CUI [1])
C2267227 (UMLS CUI [2])
Manic episode
Item
history of manic episode.
boolean
C0349208 (UMLS CUI [1])
Schizophrenia | Psychotic Disorder
Item
past or current dsm- iv-tr diagnosis of schizophrenia or other psychotic disorder.
boolean
C0036341 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
Substance Use Disorders
Item
diagnosis of substance abuse (alcohol or drug) by the dsm-iv-tr criteria.
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Pregnancy Possible | Breast Feeding
Item
pregnant, possibly pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Suicidal
Item
must not be suicidal.
boolean
C0438696 (UMLS CUI [1])
Blood Pressure | Systolic Pressure | Diastolic blood pressure
Item
blood pressure of sbp>160mmhg, dbp>100mmhg.
boolean
C0005823 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
cancer complication | Malignant Neoplasms
Item
history or complication of cancer or malignant tumour.
boolean
C0596237 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
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