ID

17068

Description

Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00385437

Link

https://clinicaltrials.gov/show/NCT00385437

Keywords

Versions (1)
  1. 8/23/16 8/23/16 -
Uploaded on

August 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00385437

English

Eligibility Depression NCT00385437

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00385437
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
fulfilling dsm-iv criteria for major depressive disorder
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
score of hamilton rating scale for depression (hdrs-17) > 17
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
patient to be prescribed mirtazapine (remeron) as determined by physician
Description

Mirtazapine prescribed | Remeron prescribed

Data type

boolean

Alias
UMLS CUI [1,1]
C0049506
UMLS CUI [1,2]
C0278329
UMLS CUI [2,1]
C0525726
UMLS CUI [2,2]
C0278329
subject has no known clinically significant abnormal vital signs or other clinical findings at screening.
Description

Abnormal vital signs Clinical Significance | Clinical findings

Data type

boolean

Alias
UMLS CUI [1,1]
C0277804
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0037088
patients should have a driving license for more than 3 years and drive over 15,000 km year.
Description

Has driving license | driving performance

Data type

boolean

Alias
UMLS CUI [1]
C2960399
UMLS CUI [2]
C0681592
females of childbearing potential must willingly use effective birth control.
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
night shift workers.
Description

Night shift worker

Data type

boolean

Alias
UMLS CUI [1]
C0555008
a history or present condition of: bipolar disorder or depressive disorder not otherwise specified,schizophrenia or other psychotic disorders (according to dsm-iv), schizotypal or borderline personality disorder, organic mental disorders
Description

Bipolar Disorder | Depressive disorder | Schizophrenia | Psychotic Disorders | Schizotypal Personality Disorder | Borderline Personality Disorder | Organic mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0011581
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0033975
UMLS CUI [5]
C0036363
UMLS CUI [6]
C0006012
UMLS CUI [7]
C0029227
a present condition of: anxiety disorders (according to dsm-iv), eating disorders, postpartum depression
Description

Anxiety Disorders | Eating Disorders | Depression, Postpartum

Data type

boolean

Alias
UMLS CUI [1]
C0003469
UMLS CUI [2]
C0013473
UMLS CUI [3]
C0221074
epilepsy or a history of seizure disorder or ever received treatment with anticonvulsant medication for epilepsy or seizures
Description

Epilepsy | Anticonvulsants Epilepsy | Anticonvulsants Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0003286
UMLS CUI [2,2]
C0014544
UMLS CUI [3,1]
C0003286
UMLS CUI [3,2]
C0036572
psg recording of an extremely abnormal sleep eeg (other than that which would be expected with depression)
Description

Polysomnography | Abnormal EEG activity during sleep Extreme | Sleep electroencephalogram | Depressive disorder

Data type

boolean

Alias
UMLS CUI [1]
C0162701
UMLS CUI [2,1]
C3279431
UMLS CUI [2,2]
C0205403
UMLS CUI [3]
C0200101
UMLS CUI [4]
C0011581
alcohol or substance abuse (according to dsm-iv) during the last 6months prior to baseline.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
any physical disease, which may explain the symptoms of depression.
Description

Disease Physical Explanation Depressive Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205485
UMLS CUI [1,3]
C0681841
UMLS CUI [1,4]
C0086132
any chronic physical disease, which is not stabilized.
Description

Disease physical chronic unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205485
UMLS CUI [1,3]
C0205191
UMLS CUI [1,4]
C0443343
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Similar models

Eligibility Depression NCT00385437

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00385437
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
fulfilling dsm-iv criteria for major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Hamilton rating scale for depression
Item
score of hamilton rating scale for depression (hdrs-17) > 17
boolean
C0451203 (UMLS CUI [1])
Mirtazapine prescribed | Remeron prescribed
Item
patient to be prescribed mirtazapine (remeron) as determined by physician
boolean
C0049506 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0525726 (UMLS CUI [2,1])
C0278329 (UMLS CUI [2,2])
Abnormal vital signs Clinical Significance | Clinical findings
Item
subject has no known clinically significant abnormal vital signs or other clinical findings at screening.
boolean
C0277804 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2])
Has driving license | driving performance
Item
patients should have a driving license for more than 3 years and drive over 15,000 km year.
boolean
C2960399 (UMLS CUI [1])
C0681592 (UMLS CUI [2])
Childbearing Potential Contraceptive methods
Item
females of childbearing potential must willingly use effective birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Night shift worker
Item
night shift workers.
boolean
C0555008 (UMLS CUI [1])
Bipolar Disorder | Depressive disorder | Schizophrenia | Psychotic Disorders | Schizotypal Personality Disorder | Borderline Personality Disorder | Organic mental disorders
Item
a history or present condition of: bipolar disorder or depressive disorder not otherwise specified,schizophrenia or other psychotic disorders (according to dsm-iv), schizotypal or borderline personality disorder, organic mental disorders
boolean
C0005586 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
C0036363 (UMLS CUI [5])
C0006012 (UMLS CUI [6])
C0029227 (UMLS CUI [7])
Anxiety Disorders | Eating Disorders | Depression, Postpartum
Item
a present condition of: anxiety disorders (according to dsm-iv), eating disorders, postpartum depression
boolean
C0003469 (UMLS CUI [1])
C0013473 (UMLS CUI [2])
C0221074 (UMLS CUI [3])
Epilepsy | Anticonvulsants Epilepsy | Anticonvulsants Seizures
Item
epilepsy or a history of seizure disorder or ever received treatment with anticonvulsant medication for epilepsy or seizures
boolean
C0014544 (UMLS CUI [1])
C0003286 (UMLS CUI [2,1])
C0014544 (UMLS CUI [2,2])
C0003286 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
Polysomnography | Abnormal EEG activity during sleep Extreme | Sleep electroencephalogram | Depressive disorder
Item
psg recording of an extremely abnormal sleep eeg (other than that which would be expected with depression)
boolean
C0162701 (UMLS CUI [1])
C3279431 (UMLS CUI [2,1])
C0205403 (UMLS CUI [2,2])
C0200101 (UMLS CUI [3])
C0011581 (UMLS CUI [4])
Substance Use Disorders
Item
alcohol or substance abuse (according to dsm-iv) during the last 6months prior to baseline.
boolean
C0038586 (UMLS CUI [1])
Disease Physical Explanation Depressive Symptoms
Item
any physical disease, which may explain the symptoms of depression.
boolean
C0012634 (UMLS CUI [1,1])
C0205485 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,3])
C0086132 (UMLS CUI [1,4])
Disease physical chronic unstable
Item
any chronic physical disease, which is not stabilized.
boolean
C0012634 (UMLS CUI [1,1])
C0205485 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0443343 (UMLS CUI [1,4])
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