ID

28909

Beskrivning

A Study Of New Medicine (GSK 372475) For The Treatment Of Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00448058

Länk

https://clinicaltrials.gov/show/NCT00448058

Nyckelord

Versioner (1)
  1. 2018-02-15 2018-02-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depressive Disorder NCT00448058

Engelsk

Eligibility Depressive Disorder NCT00448058

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Single major depressive episode Associated with Major Depressive Disorder

Datatyp

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
Beskrivning

Depressive episode Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
symptoms of decreased energy, pleasure, and interest
Beskrivning

Symptoms Fatigue | Loss of interest or pleasure (symptom)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0015672
UMLS CUI [2]
C2185938
female subjects who agree to use acceptable methods of birth control throughout the study
Beskrivning

Gender | Contraceptive methods Agreement

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0680240
Exclusion Criteria
Beskrivning

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
Beskrivning

Panic Disorder | Symptoms Generalized anxiety | Panic Attacks Interfere with Ability Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1]
C0030319
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0262376
UMLS CUI [3,1]
C0086769
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0085732
UMLS CUI [3,4]
C2732579
symptoms of mde better accounted for by another diagnosis
Beskrivning

Symptoms Major depressive episode | Preference Diagnosis Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0024517
UMLS CUI [2,1]
C0558295
UMLS CUI [2,2]
C0011900
UMLS CUI [2,3]
C0205394
diagnosis of bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia.
Beskrivning

Bipolar Disorder | Schizophrenia | Psychotic Disorders | Borderline Personality Disorder | Antisocial Personality Disorder | Dementia

Datatyp

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0006012
UMLS CUI [5]
C0003431
UMLS CUI [6]
C0497327
started psychotherapy within 3 months prior to the screening
Beskrivning

Psychotherapy Started

Datatyp

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
Beskrivning

Electroconvulsive Therapy | Transcranial magnetic stimulation

Datatyp

boolean

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

Psychotropic Drugs

Datatyp

boolean

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

Urine drug screen positive | Blood alcohol test positive

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Pregnancy test positive

Datatyp

boolean

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

Epilepsy | Myocardial Infarction | Medical condition Unstable

Datatyp

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
Beskrivning

Pharmacotherapy Course Unresponsive to Treatment | Antidepressive Agents Different Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C1705242
UMLS CUI [2,3]
C1265611
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Similar models

Eligibility Depressive Disorder NCT00448058

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Single 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])
Depressive episode Duration
Item
duration of current episode is at least 12 weeks duration and less than 2 years
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Symptoms Fatigue | Loss of interest or pleasure (symptom)
Item
symptoms of decreased energy, pleasure, and interest
boolean
C1457887 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
C2185938 (UMLS CUI [2])
Gender | Contraceptive methods Agreement
Item
female subjects who agree to use acceptable methods of birth control throughout the study
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0680240 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Panic Disorder | Symptoms Generalized anxiety | Panic Attacks Interfere with Ability Completion of clinical trial
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])
C1457887 (UMLS CUI [2,1])
C0262376 (UMLS CUI [2,2])
C0086769 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0085732 (UMLS CUI [3,3])
C2732579 (UMLS CUI [3,4])
Symptoms Major depressive episode | Preference Diagnosis Other
Item
symptoms of mde better accounted for by another diagnosis
boolean
C1457887 (UMLS CUI [1,1])
C0024517 (UMLS CUI [1,2])
C0558295 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
Bipolar Disorder | Schizophrenia | Psychotic Disorders | Borderline Personality Disorder | Antisocial Personality Disorder | Dementia
Item
diagnosis of bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia.
boolean
C0005586 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0006012 (UMLS CUI [4])
C0003431 (UMLS CUI [5])
C0497327 (UMLS CUI [6])
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 | Family history Suicide attempt
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])
C0241889 (UMLS CUI [3,1])
C0038663 (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 Course Unresponsive to Treatment | Antidepressive Agents Different Quantity
Item
failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants
boolean
C0013216 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
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