ID

20553

Description

MDD POC Study GSK372475 Subjects Depressive Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00420641

Link

https://clinicaltrials.gov/show/NCT00420641

Keywords

Versions (1)
  1. 3/2/17 3/2/17 -
Uploaded on

March 2, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Depressive Disorder NCT00420641

English

Eligibility Depressive Disorder NCT00420641

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
major depressive episode (mde) associated with major depressive disorder (dsm-iv-tr criteria)
Description

Major depressive episode Associated with Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1269683
duration of current episode is at least 12 weeks duration and less than 2 years
Description

Major depressive episode Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
symptoms of decreased energy, pleasure, and interest
Description

Fatigue Symptoms | Pleasure Decreased Symptoms | Loss of interest Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C1457887
UMLS CUI [2,1]
C0679105
UMLS CUI [2,2]
C0205216
UMLS CUI [2,3]
C1457887
UMLS CUI [3,1]
C0424091
UMLS CUI [3,2]
C1457887
female subjects who agree to use acceptable methods of birth control throughout the study
Description

Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current diagnosis of panic disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial
Description

Panic Disorder | Generalized anxiety Symptoms Interfere with Protocol Compliance | Panic Attacks Interfere with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0030319
UMLS CUI [2,1]
C0262376
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C0086769
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
symptoms of mde better accounted for by another diagnosis
Description

Major depressive episode Symptoms | Diagnosis Alternative Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C1457887
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C1523987
UMLS CUI [2,3]
C1514873
diagnosis of panic disorder / attacks, generalised anxiety, borderline or antisocial personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of screening), bipolar disorder, schizophrenia or any other psychotic disorder(s).
Description

Panic Disorder | Panic Attacks | anxiety generalized | Borderline Personality Disorder | Antisocial Personality Disorder | Dementia | Anorexia Nervosa | Bulimia | Bipolar Disorder | Schizophrenia | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0030319
UMLS CUI [2]
C0086769
UMLS CUI [3]
C0262376
UMLS CUI [4]
C0006012
UMLS CUI [5]
C0003431
UMLS CUI [6]
C0497327
UMLS CUI [7]
C0003125
UMLS CUI [8]
C0006370
UMLS CUI [9]
C0005586
UMLS CUI [10]
C0036341
UMLS CUI [11]
C0033975
started psychotherapy within 3 months prior to the screening
Description

Psychotherapy Started

Data type

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C1272689
received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening
Description

Electroconvulsive Therapy | Transcranial magnetic stimulation

Data type

boolean

Alias
UMLS CUI [1]
C0013806
UMLS CUI [2]
C0436548
received psychoactive drugs within 4 weeks of randomization
Description

Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0033978
positive urine drug screen or positive blood alcohol
Description

Urine drug screen positive | Blood alcohol test positive

Data type

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0948726
suicidal risk or has had any previous suicide attempt, a family history of suicide attempt
Description

At risk for suicide | Suicide attempt | Suicide attempt Family history

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C0038663
UMLS CUI [3,1]
C0038663
UMLS CUI [3,2]
C0241889
positive pregnancy test
Description

Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0240802
history of seizure disorder, myocardial infarction (< 1yr), or unstable medical condition
Description

Epilepsy | Myocardial Infarction | Medical condition Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0443343
failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants
Description

Pharmacotherapy failed | Antidepressive Agents Different failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C1705242
UMLS CUI [2,3]
C0231175
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Similar models

Eligibility Depressive Disorder NCT00420641

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major depressive episode Associated with Major Depressive Disorder
Item
major depressive episode (mde) associated with major depressive disorder (dsm-iv-tr criteria)
boolean
C0024517 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1269683 (UMLS CUI [1,3])
Major depressive episode Duration
Item
duration of current episode is at least 12 weeks duration and less than 2 years
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Fatigue Symptoms | Pleasure Decreased Symptoms | Loss of interest Symptoms
Item
symptoms of decreased energy, pleasure, and interest
boolean
C0015672 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0679105 (UMLS CUI [2,1])
C0205216 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0424091 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
Gender Contraceptive methods
Item
female subjects who agree to use acceptable methods of birth control throughout the study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Panic Disorder | Generalized anxiety Symptoms Interfere with Protocol Compliance | Panic Attacks Interfere with Protocol Compliance
Item
current diagnosis of panic disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial
boolean
C0030319 (UMLS CUI [1])
C0262376 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C0086769 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Major depressive episode Symptoms | Diagnosis Alternative Required
Item
symptoms of mde better accounted for by another diagnosis
boolean
C0024517 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C1523987 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Panic Disorder | Panic Attacks | anxiety generalized | Borderline Personality Disorder | Antisocial Personality Disorder | Dementia | Anorexia Nervosa | Bulimia | Bipolar Disorder | Schizophrenia | Psychotic Disorders
Item
diagnosis of panic disorder / attacks, generalised anxiety, borderline or antisocial personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of screening), bipolar disorder, schizophrenia or any other psychotic disorder(s).
boolean
C0030319 (UMLS CUI [1])
C0086769 (UMLS CUI [2])
C0262376 (UMLS CUI [3])
C0006012 (UMLS CUI [4])
C0003431 (UMLS CUI [5])
C0497327 (UMLS CUI [6])
C0003125 (UMLS CUI [7])
C0006370 (UMLS CUI [8])
C0005586 (UMLS CUI [9])
C0036341 (UMLS CUI [10])
C0033975 (UMLS CUI [11])
Psychotherapy Started
Item
started psychotherapy within 3 months prior to the screening
boolean
C0033968 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
Electroconvulsive Therapy | Transcranial magnetic stimulation
Item
received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening
boolean
C0013806 (UMLS CUI [1])
C0436548 (UMLS CUI [2])
Psychotropic Drugs
Item
received psychoactive drugs within 4 weeks of randomization
boolean
C0033978 (UMLS CUI [1])
Urine drug screen positive | Blood alcohol test positive
Item
positive urine drug screen or positive blood alcohol
boolean
C0743300 (UMLS CUI [1])
C0948726 (UMLS CUI [2])
At risk for suicide | Suicide attempt | Suicide attempt Family history
Item
suicidal risk or has had any previous suicide attempt, a family history of suicide attempt
boolean
C0563664 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
C0038663 (UMLS CUI [3,1])
C0241889 (UMLS CUI [3,2])
Pregnancy test positive
Item
positive pregnancy test
boolean
C0240802 (UMLS CUI [1])
Epilepsy | Myocardial Infarction | Medical condition Unstable
Item
history of seizure disorder, myocardial infarction (< 1yr), or unstable medical condition
boolean
C0014544 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C3843040 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
Pharmacotherapy failed | Antidepressive Agents Different failed
Item
failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants
boolean
C0013216 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
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