ID

30485

Description

Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00672620

Lien

https://clinicaltrials.gov/show/NCT00672620

Mots-clés

Versions (1)
  1. 08/06/2018 08/06/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

8 juin 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00672620

Anglais

Eligibility Major Depressive Disorder NCT00672620

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
suffers from a major depressive episode as the primary diagnosis according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria.
Description

Major depressive episode Principal diagnosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0332137
the reported duration of the current major depressive episode is at least 3 months.
Description

Major depressive episode Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has 1 or more the following:
Description

Criteria Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
any current psychiatric disorder other than major depressive disorder as defined in the dsm-iv-tr.
Description

Mental disorder Any | Exception Major Depressive Disorder

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1552551
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1269683
current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the dsm-iv-tr.
Description

Manic episode | Hypomanic episode | Schizophrenia | Psychotic Disorders | Major depression with psychotic features | Mental Retardation | Organic mental disorders | Mental disorders Due to Medical condition General

Type de données

boolean

Alias
UMLS CUI [1]
C0349208
UMLS CUI [2]
C1396834
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0033975
UMLS CUI [5]
C4518519
UMLS CUI [6]
C0025362
UMLS CUI [7]
C0029227
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C3843040
UMLS CUI [8,4]
C0205246
any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the dsm-iv-tr.
Description

Substance Use Disorders | Exception Nicotine Use Disorder | Exception Caffeine related disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0376384
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0236734
presence or history of a clinically significant neurological disorder (including epilepsy).
Description

Nervous system disorder | Epilepsy

Type de données

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0014544
neurodegenerative disorder (alzheimer disease, parkinson disease, multiple sclerosis, huntington disease, etc).
Description

Neurodegenerative Disorders | Alzheimer's Disease | Parkinson Disease | Multiple Sclerosis | Huntington Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0524851
UMLS CUI [2]
C0002395
UMLS CUI [3]
C0030567
UMLS CUI [4]
C0026769
UMLS CUI [5]
C0020179
any axis ii disorder that might compromise the study.
Description

Axis II diagnosis compromises Clinical Trial

Type de données

boolean

Alias
UMLS CUI [1,1]
C0270288
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0008976
has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the montgomery åsberg depression rating scale (madrs) or has made a suicide attempt in the previous 6 months.
Description

At risk for suicide | Feeling suicidal Montgomery-Asberg Depression Rating Scale Questionnaire | Suicide attempt

Type de données

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0424000
UMLS CUI [2,2]
C4054475
UMLS CUI [3]
C0038663
the current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Description

Depressive Symptoms Resistant to Antidepressant therapy Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C1096649
UMLS CUI [1,4]
C1265611
has received electroconvulsive therapy within 6 months prior to screening.
Description

Electroconvulsive Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0013806
is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Description

Cognitive Therapy | Behavior Therapy | Psychotherapy systematic | Cognitive Therapy Planned | Behavior Therapy Planned | Psychotherapy systematic Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0009244
UMLS CUI [2]
C0004933
UMLS CUI [3,1]
C0033968
UMLS CUI [3,2]
C0220922
UMLS CUI [4,1]
C0009244
UMLS CUI [4,2]
C1301732
UMLS CUI [5,1]
C0004933
UMLS CUI [5,2]
C1301732
UMLS CUI [6,1]
C0033968
UMLS CUI [6,2]
C0220922
UMLS CUI [6,3]
C1301732
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Similar models

Eligibility Major Depressive Disorder NCT00672620

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Major depressive episode Principal diagnosis
Item
suffers from a major depressive episode as the primary diagnosis according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria.
boolean
C0024517 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
Major depressive episode Duration
Item
the reported duration of the current major depressive episode is at least 3 months.
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
has 1 or more the following:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Mental disorder Any | Exception Major Depressive Disorder
Item
any current psychiatric disorder other than major depressive disorder as defined in the dsm-iv-tr.
boolean
C0004936 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
Manic episode | Hypomanic episode | Schizophrenia | Psychotic Disorders | Major depression with psychotic features | Mental Retardation | Organic mental disorders | Mental disorders Due to Medical condition General
Item
current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the dsm-iv-tr.
boolean
C0349208 (UMLS CUI [1])
C1396834 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
C4518519 (UMLS CUI [5])
C0025362 (UMLS CUI [6])
C0029227 (UMLS CUI [7])
C0004936 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C3843040 (UMLS CUI [8,3])
C0205246 (UMLS CUI [8,4])
Substance Use Disorders | Exception Nicotine Use Disorder | Exception Caffeine related disorders
Item
any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the dsm-iv-tr.
boolean
C0038586 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0376384 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0236734 (UMLS CUI [3,2])
Nervous system disorder | Epilepsy
Item
presence or history of a clinically significant neurological disorder (including epilepsy).
boolean
C0027765 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Neurodegenerative Disorders | Alzheimer's Disease | Parkinson Disease | Multiple Sclerosis | Huntington Disease
Item
neurodegenerative disorder (alzheimer disease, parkinson disease, multiple sclerosis, huntington disease, etc).
boolean
C0524851 (UMLS CUI [1])
C0002395 (UMLS CUI [2])
C0030567 (UMLS CUI [3])
C0026769 (UMLS CUI [4])
C0020179 (UMLS CUI [5])
Axis II diagnosis compromises Clinical Trial
Item
any axis ii disorder that might compromise the study.
boolean
C0270288 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
At risk for suicide | Feeling suicidal Montgomery-Asberg Depression Rating Scale Questionnaire | Suicide attempt
Item
has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the montgomery åsberg depression rating scale (madrs) or has made a suicide attempt in the previous 6 months.
boolean
C0563664 (UMLS CUI [1])
C0424000 (UMLS CUI [2,1])
C4054475 (UMLS CUI [2,2])
C0038663 (UMLS CUI [3])
Depressive Symptoms Resistant to Antidepressant therapy Quantity
Item
the current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
boolean
C0086132 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C1096649 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Electroconvulsive Therapy
Item
has received electroconvulsive therapy within 6 months prior to screening.
boolean
C0013806 (UMLS CUI [1])
Cognitive Therapy | Behavior Therapy | Psychotherapy systematic | Cognitive Therapy Planned | Behavior Therapy Planned | Psychotherapy systematic Planned
Item
is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
boolean
C0009244 (UMLS CUI [1])
C0004933 (UMLS CUI [2])
C0033968 (UMLS CUI [3,1])
C0220922 (UMLS CUI [3,2])
C0009244 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0004933 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C0033968 (UMLS CUI [6,1])
C0220922 (UMLS CUI [6,2])
C1301732 (UMLS CUI [6,3])
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