ID

18084

Description

Study Evaluating DVS-233 for Treatment of Outpatients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00452595

Link

https://clinicaltrials.gov/show/NCT00452595

Keywords

Versions (1)
  1. 10/18/16 10/18/16 -
Uploaded on

October 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00452595

English

Eligibility Major Depressive Disorder NCT00452595

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients.
Description

Outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
men and women aged 18 to 75 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential must have a negative serum pregnancy test result at screening. sexually active individuals participating in this study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article.
Description

Childbearing Potential Serum pregnancy test negative | Sex Behavior Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C0036864
UMLS CUI [2,2]
C0700589
subjects must have a primary diagnosis of mdd based on the criteria in the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv), single or recurrent episode, without psychotic features, on study day 1. if other allowable psychiatric diagnoses are present, mdd must be the predominant psychiatric disorder present. (see exclusion criterion 6 for psychiatric diagnoses that are not allowable.)
Description

Major Depressive Disorder Principal diagnosis | Single major depressive episode | Recurrent major depressive episodes | depression psychotic feature Lacking | Mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332137
UMLS CUI [2]
C0024517
UMLS CUI [3]
C0154409
UMLS CUI [4,1]
C0743076
UMLS CUI [4,2]
C0332268
UMLS CUI [5]
C0004936
depressive symptoms for at least 30 days before the screening visit.
Description

Depressive Symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0086132
subjects who have symptoms of depression judged by the investigator to require long-term treatment (i.e., 6 months or longer) with an antidepressant drug.
Description

Depressive Symptoms Requirement Antidepressive Agents long-term care

Data type

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003289
UMLS CUI [1,4]
C0023977
other inclusion applies.
Description

Inclusion criteria Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205394
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with dvs-233 sr at any time in the past.
Description

desvenlafaxine succinate Sustained Release

Data type

boolean

Alias
UMLS CUI [1,1]
C1742884
UMLS CUI [1,2]
C1710261
treatment with venlafaxine (immediate release [ir] or extended release [er]) within 90 days of study day 1.
Description

venlafaxine Immediate Release | venlafaxine Extended Release

Data type

boolean

Alias
UMLS CUI [1,1]
C0078569
UMLS CUI [1,2]
C1708470
UMLS CUI [2,1]
C0078569
UMLS CUI [2,2]
C1707968
known hypersensitivity to venlafaxine (ir or er).
Description

Hypersensitivity venlafaxine Immediate Release | Hypersensitivity venlafaxine Extended Release

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0078569
UMLS CUI [1,3]
C1708470
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0078569
UMLS CUI [2,3]
C1707968
significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
Description

At risk for suicide Significant | Feeling suicidal

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0424000
women who are pregnant, breastfeeding, or planning to become pregnant during the study.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
current (within 12 months of baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified mini international neuropsychiatric interview (mini). current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified mini and considered by the investigator to be primary, causing a higher degree of distress or impairment than mdd. presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic).
Description

Psychoactive substance abuse | psychoactive substance dependence | Alcohol abuse | Alcoholic Intoxication, Chronic | Manic episode | Post-Traumatic Stress Disorder | Obsessive-Compulsive Disorder | Bipolar Disorder Lifetime | Psychotic Disorders Lifetime | Generalized Anxiety Disorder | Panic Disorder | Phobia, Social | Distress degree | Impairment degree | Major Depressive Disorder | Personality Disorders | Antisocial Personality Disorder | Schizotypal Personality Disorder | Histrionic Personality Disorder | Borderline Personality Disorder | Narcissistic Personality Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0033880
UMLS CUI [2]
C2062765
UMLS CUI [3]
C0085762
UMLS CUI [4]
C0001973
UMLS CUI [5]
C0349208
UMLS CUI [6]
C0038436
UMLS CUI [7]
C0028768
UMLS CUI [8,1]
C0005586
UMLS CUI [8,2]
C4071830
UMLS CUI [9,1]
C0033975
UMLS CUI [9,2]
C4071830
UMLS CUI [10]
C0270549
UMLS CUI [11]
C0030319
UMLS CUI [12]
C0031572
UMLS CUI [13,1]
C0231303
UMLS CUI [13,2]
C0441889
UMLS CUI [14,1]
C0221099
UMLS CUI [14,2]
C0441889
UMLS CUI [15]
C1269683
UMLS CUI [16]
C0031212
UMLS CUI [17]
C0003431
UMLS CUI [18]
C0036363
UMLS CUI [19]
C0019681
UMLS CUI [20]
C0006012
UMLS CUI [21]
C0027402
depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder.
Description

Depressive disorder Associated with organic mental disorder Due to Medical condition General | Depressive disorder Associated with organic mental disorder Due to nervous system disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0029227
UMLS CUI [1,4]
C0678226
UMLS CUI [1,5]
C3843040
UMLS CUI [1,6]
C0205246
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0029227
UMLS CUI [2,4]
C0678226
UMLS CUI [2,5]
C0027765
history of a seizure disorder other than a single childhood febrile seizure.
Description

Epilepsy | Febrile Convulsion Single

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0009952
UMLS CUI [2,2]
C0205171
other exclusion applies.
Description

Exclusion Criteria Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Major Depressive Disorder NCT00452595

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients
Item
outpatients.
boolean
C0029921 (UMLS CUI [1])
Age
Item
men and women aged 18 to 75 years.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Sex Behavior Contraceptive methods
Item
women of childbearing potential must have a negative serum pregnancy test result at screening. sexually active individuals participating in this study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0036864 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Major Depressive Disorder Principal diagnosis | Single major depressive episode | Recurrent major depressive episodes | depression psychotic feature Lacking | Mental disorders
Item
subjects must have a primary diagnosis of mdd based on the criteria in the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv), single or recurrent episode, without psychotic features, on study day 1. if other allowable psychiatric diagnoses are present, mdd must be the predominant psychiatric disorder present. (see exclusion criterion 6 for psychiatric diagnoses that are not allowable.)
boolean
C1269683 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
C0024517 (UMLS CUI [2])
C0154409 (UMLS CUI [3])
C0743076 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5])
Depressive Symptoms
Item
depressive symptoms for at least 30 days before the screening visit.
boolean
C0086132 (UMLS CUI [1])
Depressive Symptoms Requirement Antidepressive Agents long-term care
Item
subjects who have symptoms of depression judged by the investigator to require long-term treatment (i.e., 6 months or longer) with an antidepressant drug.
boolean
C0086132 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003289 (UMLS CUI [1,3])
C0023977 (UMLS CUI [1,4])
Inclusion criteria Other
Item
other inclusion applies.
boolean
C1512693 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
desvenlafaxine succinate Sustained Release
Item
treatment with dvs-233 sr at any time in the past.
boolean
C1742884 (UMLS CUI [1,1])
C1710261 (UMLS CUI [1,2])
venlafaxine Immediate Release | venlafaxine Extended Release
Item
treatment with venlafaxine (immediate release [ir] or extended release [er]) within 90 days of study day 1.
boolean
C0078569 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0078569 (UMLS CUI [2,1])
C1707968 (UMLS CUI [2,2])
Hypersensitivity venlafaxine Immediate Release | Hypersensitivity venlafaxine Extended Release
Item
known hypersensitivity to venlafaxine (ir or er).
boolean
C0020517 (UMLS CUI [1,1])
C0078569 (UMLS CUI [1,2])
C1708470 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0078569 (UMLS CUI [2,2])
C1707968 (UMLS CUI [2,3])
At risk for suicide Significant | Feeling suicidal
Item
significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
boolean
C0563664 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0424000 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, breastfeeding, or planning to become pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Psychoactive substance abuse | psychoactive substance dependence | Alcohol abuse | Alcoholic Intoxication, Chronic | Manic episode | Post-Traumatic Stress Disorder | Obsessive-Compulsive Disorder | Bipolar Disorder Lifetime | Psychotic Disorders Lifetime | Generalized Anxiety Disorder | Panic Disorder | Phobia, Social | Distress degree | Impairment degree | Major Depressive Disorder | Personality Disorders | Antisocial Personality Disorder | Schizotypal Personality Disorder | Histrionic Personality Disorder | Borderline Personality Disorder | Narcissistic Personality Disorder
Item
current (within 12 months of baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified mini international neuropsychiatric interview (mini). current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified mini and considered by the investigator to be primary, causing a higher degree of distress or impairment than mdd. presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic).
boolean
C0033880 (UMLS CUI [1])
C2062765 (UMLS CUI [2])
C0085762 (UMLS CUI [3])
C0001973 (UMLS CUI [4])
C0349208 (UMLS CUI [5])
C0038436 (UMLS CUI [6])
C0028768 (UMLS CUI [7])
C0005586 (UMLS CUI [8,1])
C4071830 (UMLS CUI [8,2])
C0033975 (UMLS CUI [9,1])
C4071830 (UMLS CUI [9,2])
C0270549 (UMLS CUI [10])
C0030319 (UMLS CUI [11])
C0031572 (UMLS CUI [12])
C0231303 (UMLS CUI [13,1])
C0441889 (UMLS CUI [13,2])
C0221099 (UMLS CUI [14,1])
C0441889 (UMLS CUI [14,2])
C1269683 (UMLS CUI [15])
C0031212 (UMLS CUI [16])
C0003431 (UMLS CUI [17])
C0036363 (UMLS CUI [18])
C0019681 (UMLS CUI [19])
C0006012 (UMLS CUI [20])
C0027402 (UMLS CUI [21])
Depressive disorder Associated with organic mental disorder Due to Medical condition General | Depressive disorder Associated with organic mental disorder Due to nervous system disorder
Item
depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder.
boolean
C0011581 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0029227 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,4])
C3843040 (UMLS CUI [1,5])
C0205246 (UMLS CUI [1,6])
C0011581 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0029227 (UMLS CUI [2,3])
C0678226 (UMLS CUI [2,4])
C0027765 (UMLS CUI [2,5])
Epilepsy | Febrile Convulsion Single
Item
history of a seizure disorder other than a single childhood febrile seizure.
boolean
C0014544 (UMLS CUI [1])
C0009952 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Exclusion Criteria Other
Item
other exclusion applies.
boolean
C0680251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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