ID

20563

Descrição

Effectiveness Study of Vilazodone to Treat Depression and to Discover Genetic Markers Associated With Response; ODM derived from: https://clinicaltrials.gov/show/NCT00285376

Link

https://clinicaltrials.gov/show/NCT00285376

Palavras-chave

Versões (1)
  1. 03/03/2017 03/03/2017 -
Transferido a

3 de março de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT00285376

Inglês

Eligibility Depressive Disorder, Major NCT00285376

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients 18-65 years of age, inclusive.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
a diagnosis of mdd, single episode or recurrent, according to dsm-iv-tr (296.2/296.3) with a current major depressive episode of less than two year's duration with a minimum duration of at least 4 weeks.
Descrição

Single major depressive episode Duration | Major Depressive Disorder Recurrent Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C2945760
UMLS CUI [2,3]
C0449238
ham-d score ≥ 22.
Descrição

Hamilton rating scale for depression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451203
ham-d item 1 (depressed mood) score ≥ 2.
Descrição

Depressed mood Hamilton rating scale for depression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0344315
UMLS CUI [1,2]
C0451203
patients must be able to provide written informed consent to participate before beginning any trial related activities.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patients must be able to speak, read and understand english and possess the ability to respond to questions and follow simple instructions.
Descrição

Able to speak English Language | Able to read English Language | Comprehension English Language | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0376245
UMLS CUI [4]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
a current (or within 6 months prior to the screening visit) axis i disorder of post traumatic stress disorder, eating disorder, obsessive compulsive disorder (generalized anxiety disorder, social phobia or simple phobia will be allowed).
Descrição

Axis I diagnosis | Post-Traumatic Stress Disorder | Eating Disorders | Obsessive-Compulsive Disorder | Generalized Anxiety Disorder | Phobia, Social | Simple phobia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0038436
UMLS CUI [3]
C0013473
UMLS CUI [4]
C0028768
UMLS CUI [5]
C0270549
UMLS CUI [6]
C0031572
UMLS CUI [7]
C0236801
a history of schizophrenia, schizoaffective disorder or bipolar i or ii disorder (with a history of hypomanic or manic episodes).
Descrição

Schizophrenia | Schizoaffective Disorder | Bipolar I disorder | Bipolar II disorder | hypomanic; episode | Manic episode

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0853193
UMLS CUI [4]
C0236788
UMLS CUI [5]
C1396834
UMLS CUI [6]
C0349208
dsm-iv-tr criteria for substance abuse (alcohol or drugs) within 3 months prior to screening visit or substance dependence within 6 months prior to the screening visit.
Descrição

Substance Use Disorders | Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
criteria for any of the following dsm-iv-tr mdd specifiers: [a] with catatonic features; [b] with postpartum onset; [c] with seasonal pattern.
Descrição

Major Depressive Disorder Catatonic phenomena | Major Depressive Disorder Onset Postpartum | Major Depressive Disorder Seasonal pattern

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0856959
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0332162
UMLS CUI [2,3]
C0086839
UMLS CUI [3,1]
C1269683
UMLS CUI [3,2]
C0085159
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Similar models

Eligibility Depressive Disorder, Major NCT00285376

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients 18-65 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
Single major depressive episode Duration | Major Depressive Disorder Recurrent Duration
Item
a diagnosis of mdd, single episode or recurrent, according to dsm-iv-tr (296.2/296.3) with a current major depressive episode of less than two year's duration with a minimum duration of at least 4 weeks.
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1269683 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Hamilton rating scale for depression
Item
ham-d score ≥ 22.
boolean
C0451203 (UMLS CUI [1])
Depressed mood Hamilton rating scale for depression
Item
ham-d item 1 (depressed mood) score ≥ 2.
boolean
C0344315 (UMLS CUI [1,1])
C0451203 (UMLS CUI [1,2])
Informed Consent
Item
patients must be able to provide written informed consent to participate before beginning any trial related activities.
boolean
C0021430 (UMLS CUI [1])
Able to speak English Language | Able to read English Language | Comprehension English Language | Protocol Compliance
Item
patients must be able to speak, read and understand english and possess the ability to respond to questions and follow simple instructions.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Post-Traumatic Stress Disorder | Eating Disorders | Obsessive-Compulsive Disorder | Generalized Anxiety Disorder | Phobia, Social | Simple phobia
Item
a current (or within 6 months prior to the screening visit) axis i disorder of post traumatic stress disorder, eating disorder, obsessive compulsive disorder (generalized anxiety disorder, social phobia or simple phobia will be allowed).
boolean
C0270287 (UMLS CUI [1])
C0038436 (UMLS CUI [2])
C0013473 (UMLS CUI [3])
C0028768 (UMLS CUI [4])
C0270549 (UMLS CUI [5])
C0031572 (UMLS CUI [6])
C0236801 (UMLS CUI [7])
Schizophrenia | Schizoaffective Disorder | Bipolar I disorder | Bipolar II disorder | hypomanic; episode | Manic episode
Item
a history of schizophrenia, schizoaffective disorder or bipolar i or ii disorder (with a history of hypomanic or manic episodes).
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0853193 (UMLS CUI [3])
C0236788 (UMLS CUI [4])
C1396834 (UMLS CUI [5])
C0349208 (UMLS CUI [6])
Substance Use Disorders | Substance Dependence
Item
dsm-iv-tr criteria for substance abuse (alcohol or drugs) within 3 months prior to screening visit or substance dependence within 6 months prior to the screening visit.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Major Depressive Disorder Catatonic phenomena | Major Depressive Disorder Onset Postpartum | Major Depressive Disorder Seasonal pattern
Item
criteria for any of the following dsm-iv-tr mdd specifiers: [a] with catatonic features; [b] with postpartum onset; [c] with seasonal pattern.
boolean
C1269683 (UMLS CUI [1,1])
C0856959 (UMLS CUI [1,2])
C1269683 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C0086839 (UMLS CUI [2,3])
C1269683 (UMLS CUI [3,1])
C0085159 (UMLS CUI [3,2])
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