ID

24589

Description

Compare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00873795

Lien

https://clinicaltrials.gov/show/NCT00873795

Mots-clés

Versions (1)
  1. 08/08/2017 08/08/2017 -
Téléchargé le

8 août 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00873795

Anglais

Eligibility Major Depressive Disorder NCT00873795

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects 18 to 65 years inclusive.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
fulfilled dsm-ⅳ criteria for major depressive disorder.
Description

Major Depressive Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C1269683
onset ≧2 weeks.
Description

Disease onset Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0277793
UMLS CUI [1,2]
C0449238
baseline score ≧14 on the ham-d17.
Description

Hamilton Depression Rating Scale 17 Item Questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C3639712
written informed consent prior to entry into the study.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ham-d17 item 3 score≧3.
Description

Hamilton Depression Rating Scale 17 Item Questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C3639712
life-time history of bipolar disorders, schizophrenia or schizoaffective disorder.
Description

Bipolar Disorder Lifetime | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005586
UMLS CUI [1,2]
C4071830
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C4071830
UMLS CUI [3,1]
C0036337
UMLS CUI [3,2]
C4071830
current history of panic disorder, obsessive-compulsive disorder, alcohol or substance abuse.
Description

Panic Disorder | Obsessive-Compulsive Disorder | Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0030319
UMLS CUI [2]
C0028768
UMLS CUI [3]
C0038586
mood disorder due to general medical condition.
Description

Mood disorder due to a general medical condition

Type de données

boolean

Alias
UMLS CUI [1]
C0236747
treatment with antidepressants at entry into the study before 2 weeks.
Description

Antidepressive Agents

Type de données

boolean

Alias
UMLS CUI [1]
C0003289
need for psychoactive medications other than the study drugs, except for one benzodiazepine or hypnotic given at a stable dose.
Description

Psychotropic Drugs Patient need for | Investigational New Drugs Excluded | Exception Benzodiazepines Quantity Dosage Stable | Exception Hypnotics Quantity Dosage Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0005064
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0178602
UMLS CUI [3,5]
C0205360
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0020591
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0178602
UMLS CUI [4,5]
C0205360
known intolerance or inefficacy to either drug.
Description

Intolerance to substance | Drug ineffective

Type de données

boolean

Alias
UMLS CUI [1]
C1744706
UMLS CUI [2]
C0852908
previous lack of response to two or more antidepressants at adequate dosage.
Description

Antidepressive Agents Quantity Dosage Absent response to treatment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0438286
subjects who have acute or unstable medical illness or organic failure.
Description

Illness | Illness Unstable | Organ failure

Type de données

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0349410
pregnancy and breast-feeding.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Major Depressive Disorder NCT00873795

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female subjects 18 to 65 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
fulfilled dsm-ⅳ criteria for major depressive disorder.
boolean
C1269683 (UMLS CUI [1])
Disease onset Duration
Item
onset ≧2 weeks.
boolean
C0277793 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
baseline score ≧14 on the ham-d17.
boolean
C3639712 (UMLS CUI [1])
Informed Consent
Item
written informed consent prior to entry into the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
ham-d17 item 3 score≧3.
boolean
C3639712 (UMLS CUI [1])
Bipolar Disorder Lifetime | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime
Item
life-time history of bipolar disorders, schizophrenia or schizoaffective disorder.
boolean
C0005586 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C0036337 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
Panic Disorder | Obsessive-Compulsive Disorder | Substance Use Disorders
Item
current history of panic disorder, obsessive-compulsive disorder, alcohol or substance abuse.
boolean
C0030319 (UMLS CUI [1])
C0028768 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Mood disorder due to a general medical condition
Item
mood disorder due to general medical condition.
boolean
C0236747 (UMLS CUI [1])
Antidepressive Agents
Item
treatment with antidepressants at entry into the study before 2 weeks.
boolean
C0003289 (UMLS CUI [1])
Psychotropic Drugs Patient need for | Investigational New Drugs Excluded | Exception Benzodiazepines Quantity Dosage Stable | Exception Hypnotics Quantity Dosage Stable
Item
need for psychoactive medications other than the study drugs, except for one benzodiazepine or hypnotic given at a stable dose.
boolean
C0033978 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0005064 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0178602 (UMLS CUI [3,4])
C0205360 (UMLS CUI [3,5])
C1705847 (UMLS CUI [4,1])
C0020591 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0178602 (UMLS CUI [4,4])
C0205360 (UMLS CUI [4,5])
Intolerance to substance | Drug ineffective
Item
known intolerance or inefficacy to either drug.
boolean
C1744706 (UMLS CUI [1])
C0852908 (UMLS CUI [2])
Antidepressive Agents Quantity Dosage Absent response to treatment
Item
previous lack of response to two or more antidepressants at adequate dosage.
boolean
C0003289 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0438286 (UMLS CUI [1,4])
Illness | Illness Unstable | Organ failure
Item
subjects who have acute or unstable medical illness or organic failure.
boolean
C0221423 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0349410 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnancy and breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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