ID

28917

Description

SA4503 8-Week Study in Major Depressive Disorder (MDD); ODM derived from: https://clinicaltrials.gov/show/NCT00551109

Link

https://clinicaltrials.gov/show/NCT00551109

Keywords

Versions (1)
  1. 2/15/18 2/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 15, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT00551109

English

Eligibility Depressive Disorder, Major NCT00551109

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female between the ages of 18 and 65 (inclusive)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of mdd according to the diagnostic and statistical manual of mental disorders (dsm)-iv criteria and a shortened mini evaluation
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
ham-d17 score of >/= 21 and a severity score of at least 2 for item 1 (depressed mood) at both screening and baseline
Description

Hamilton Depression Rating Scale 17 Item Questionnaire | Depressed mood Hamilton Depression Rating Scale 17 Item Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2,1]
C0344315
UMLS CUI [2,2]
C3639712
current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to screening.
Description

Depressive episode Duration | Depressed mood | Anhedonia

Data type

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0344315
UMLS CUI [3]
C0178417
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have received fluoxetine within 1 month prior to baseline or any other antidepressant within 2 weeks prior to baseline, or any unlicensed medication within 1 month before screening
Description

Fluoxetine | Antidepressive Agents | Pharmaceutical Preparations Without License

Data type

boolean

Alias
UMLS CUI [1]
C0016365
UMLS CUI [2]
C0003289
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332288
UMLS CUI [3,3]
C0023636
subjects who require psychotropic medication other than the study medication
Description

Patient need for Psychotropic Drugs | Exception Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0033978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013230
subjects who started psychotherapy within 4 months prior to screening
Description

Psychotherapy Started

Data type

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C1272689
subjects who currently (i.e., in the month prior to screening) meet dsm-iv criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders
Description

Syndrome Bipolar | Depression, psychotic | Somatoform Disorder Severe | Eating Disorder Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0039082
UMLS CUI [1,2]
C0443156
UMLS CUI [2]
C0743072
UMLS CUI [3,1]
C0037650
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0013473
UMLS CUI [4,2]
C0205082
subjects who have a primary diagnosis of anxiety
Description

Principal diagnosis Anxiety

Data type

boolean

Alias
UMLS CUI [1,1]
C0332137
UMLS CUI [1,2]
C0003467
subjects who regularly use sleeping medication more than 3 times per week
Description

Sleeping pills Regular Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C0599396
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0439603
subjects who have major psychiatric or neurologic disorders other than mdd
Description

Mental disorders Severe | Nervous system disorder Severe | Exception Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1269683
subjects with depression secondary to stroke, cancer, or other severe medical illness
Description

Depressive disorder Secondary to Cerebrovascular accident | Depressive disorder Secondary to Malignant Neoplasms | Depressive disorder Secondary to Severe disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0038454
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C0011581
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C1836348
subjects who have a history of alcohol or substance dependence(within 1 year prior to screening)
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
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Similar models

Eligibility Depressive Disorder, Major NCT00551109

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female between the ages of 18 and 65 (inclusive)
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
diagnosis of mdd according to the diagnostic and statistical manual of mental disorders (dsm)-iv criteria and a shortened mini evaluation
boolean
C1269683 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Questionnaire | Depressed mood Hamilton Depression Rating Scale 17 Item Questionnaire
Item
ham-d17 score of >/= 21 and a severity score of at least 2 for item 1 (depressed mood) at both screening and baseline
boolean
C3639712 (UMLS CUI [1])
C0344315 (UMLS CUI [2,1])
C3639712 (UMLS CUI [2,2])
Depressive episode Duration | Depressed mood | Anhedonia
Item
current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to screening.
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0344315 (UMLS CUI [2])
C0178417 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Fluoxetine | Antidepressive Agents | Pharmaceutical Preparations Without License
Item
subjects who have received fluoxetine within 1 month prior to baseline or any other antidepressant within 2 weeks prior to baseline, or any unlicensed medication within 1 month before screening
boolean
C0016365 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0332288 (UMLS CUI [3,2])
C0023636 (UMLS CUI [3,3])
Patient need for Psychotropic Drugs | Exception Investigational New Drugs
Item
subjects who require psychotropic medication other than the study medication
boolean
C0686904 (UMLS CUI [1,1])
C0033978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Psychotherapy Started
Item
subjects who started psychotherapy within 4 months prior to screening
boolean
C0033968 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
Syndrome Bipolar | Depression, psychotic | Somatoform Disorder Severe | Eating Disorder Severe
Item
subjects who currently (i.e., in the month prior to screening) meet dsm-iv criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders
boolean
C0039082 (UMLS CUI [1,1])
C0443156 (UMLS CUI [1,2])
C0743072 (UMLS CUI [2])
C0037650 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0013473 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Principal diagnosis Anxiety
Item
subjects who have a primary diagnosis of anxiety
boolean
C0332137 (UMLS CUI [1,1])
C0003467 (UMLS CUI [1,2])
Sleeping pills Regular Frequency
Item
subjects who regularly use sleeping medication more than 3 times per week
boolean
C0599396 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Mental disorders Severe | Nervous system disorder Severe | Exception Major Depressive Disorder
Item
subjects who have major psychiatric or neurologic disorders other than mdd
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1269683 (UMLS CUI [3,2])
Depressive disorder Secondary to Cerebrovascular accident | Depressive disorder Secondary to Malignant Neoplasms | Depressive disorder Secondary to Severe disorder
Item
subjects with depression secondary to stroke, cancer, or other severe medical illness
boolean
C0011581 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,3])
C0011581 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C0011581 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C1836348 (UMLS CUI [3,3])
Substance Dependence
Item
subjects who have a history of alcohol or substance dependence(within 1 year prior to screening)
boolean
C0038580 (UMLS CUI [1])
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