ID

30506

Description

Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00807248

Link

https://clinicaltrials.gov/show/NCT00807248

Keywords

Versions (1)
  1. 6/10/18 6/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00807248

English

Eligibility Major Depressive Disorder NCT00807248

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of mdd according to dsm-iv-tr criteria:
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
with reported duration of the current major depressive episode of at least 3 months
Description

Major depressive episode Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
with madrs total score of at least 30
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has 1 or more of the following:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
any current psychiatric disorder other than mdd as defined in the dsm-iv-tr
Description

Mental disorders | Exception Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1269683
current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the dsm-iv-tr
Description

Manic episode | Hypomanic episode | Schizophrenia | Psychotic Disorders | Major depression with psychotic features | Mental Retardation | Organic mental disorders | Mental disorders Due to Medical condition General

Data type

boolean

Alias
UMLS CUI [1]
C0349208
UMLS CUI [2]
C1396834
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0033975
UMLS CUI [5]
C4518519
UMLS CUI [6]
C0025362
UMLS CUI [7]
C0029227
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C3843040
UMLS CUI [8,4]
C0205246
any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the dsm-iv-tr
Description

Substance Use Disorders | Exception Nicotine Use Disorder | Exception Caffeine related disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0376384
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0236734
presence or history of a clinically significant neurological disorder (including epilepsy)
Description

Nervous system disorder | Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0014544
neurodegenerative disorder (alzheimer disease, parkinson disease, multiple sclerosis, huntington disease, etc)
Description

Neurodegenerative Disorders | Alzheimer's Disease | Parkinson Disease | Multiple Sclerosis | Huntington Disease

Data type

boolean

Alias
UMLS CUI [1]
C0524851
UMLS CUI [2]
C0002395
UMLS CUI [3]
C0030567
UMLS CUI [4]
C0026769
UMLS CUI [5]
C0020179
any axis ii disorder that might compromise the study
Description

Axis II diagnosis compromises Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0270288
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0008976
previous use of hallucinogenic drug
Description

Hallucinogens

Data type

boolean

Alias
UMLS CUI [1]
C0018533
the patient has a significant risk of suicide according to the investigator's opinion, or has a score >=5 on item 10 (suicidal thoughts) of the madrs, or has made a suicide attempt in the previous 12 months.
Description

At risk for suicide | Feeling suicidal Montgomery-Asberg Depression Rating Scale Questionnaire | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0424000
UMLS CUI [2,2]
C4054475
UMLS CUI [3]
C0038663
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Similar models

Eligibility Major Depressive Disorder NCT00807248

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
clinical diagnosis of mdd according to dsm-iv-tr criteria:
boolean
C1269683 (UMLS CUI [1])
Major depressive episode Duration
Item
with reported duration of the current major depressive episode of at least 3 months
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
with madrs total score of at least 30
boolean
C4054475 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
the patient has 1 or more of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Mental disorders | Exception Major Depressive Disorder
Item
any current psychiatric disorder other than mdd as defined in the dsm-iv-tr
boolean
C0004936 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
Manic episode | Hypomanic episode | Schizophrenia | Psychotic Disorders | Major depression with psychotic features | Mental Retardation | Organic mental disorders | Mental disorders Due to Medical condition General
Item
current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the dsm-iv-tr
boolean
C0349208 (UMLS CUI [1])
C1396834 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
C4518519 (UMLS CUI [5])
C0025362 (UMLS CUI [6])
C0029227 (UMLS CUI [7])
C0004936 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C3843040 (UMLS CUI [8,3])
C0205246 (UMLS CUI [8,4])
Substance Use Disorders | Exception Nicotine Use Disorder | Exception Caffeine related disorders
Item
any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the dsm-iv-tr
boolean
C0038586 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0376384 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0236734 (UMLS CUI [3,2])
Nervous system disorder | Epilepsy
Item
presence or history of a clinically significant neurological disorder (including epilepsy)
boolean
C0027765 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Neurodegenerative Disorders | Alzheimer's Disease | Parkinson Disease | Multiple Sclerosis | Huntington Disease
Item
neurodegenerative disorder (alzheimer disease, parkinson disease, multiple sclerosis, huntington disease, etc)
boolean
C0524851 (UMLS CUI [1])
C0002395 (UMLS CUI [2])
C0030567 (UMLS CUI [3])
C0026769 (UMLS CUI [4])
C0020179 (UMLS CUI [5])
Axis II diagnosis compromises Clinical Trial
Item
any axis ii disorder that might compromise the study
boolean
C0270288 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Hallucinogens
Item
previous use of hallucinogenic drug
boolean
C0018533 (UMLS CUI [1])
At risk for suicide | Feeling suicidal Montgomery-Asberg Depression Rating Scale Questionnaire | Suicide attempt
Item
the patient has a significant risk of suicide according to the investigator's opinion, or has a score >=5 on item 10 (suicidal thoughts) of the madrs, or has made a suicide attempt in the previous 12 months.
boolean
C0563664 (UMLS CUI [1])
C0424000 (UMLS CUI [2,1])
C4054475 (UMLS CUI [2,2])
C0038663 (UMLS CUI [3])
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