ID

33891

Descripción

Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD); ODM derived from: https://clinicaltrials.gov/show/NCT01724112

Link

https://clinicaltrials.gov/show/NCT01724112

Palabras clave

Versiones (1)
  1. 5/1/19 5/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT01724112

Inglés

Eligibility Major Depressive Disorder NCT01724112

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of major depressive disorder (mdd) without psychotic features as defined in the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr)
Descripción

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0743081
have clinically significant depressive symptoms defined by a grid hamd17 total score
Descripción

Depressive Symptoms Hamilton Depression Rating Scale 17 Item Clinical Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C3639712
≥20 at screening
Descripción

ID.3

Tipo de datos

boolean

body mass index (bmi) between 18 and 35 kilogram per square meter (kg/m^2)
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a current or previous diagnosis of bipolar i or ii disorder, mdd with psychotic features, schizoaffective disorder, schizophrenia, or other psychotic disorder
Descripción

Bipolar I disorder | Bipolar II disorder | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE | Schizoaffective Disorder | Schizophrenia | Psychotic Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0853193
UMLS CUI [2]
C0236788
UMLS CUI [3]
C0743080
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0036341
UMLS CUI [6]
C0033975
currently meeting the criteria of treatment-resistant depression defined as ≥2 documented, failed treatment trials of adequate dose and duration with a registered antidepressant during the current depressive episode
Descripción

Depressive Disorder, Treatment-Resistant | Antidepressant therapy Quantity failed | Depressive episode

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2063866
UMLS CUI [2,1]
C1096649
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C0349217
had electroconvulsive treatment, transcranial magnetic stimulation, vagal nerve stimulation for symptoms of depression in the 6 months prior to screening
Descripción

Electroconvulsive Therapy Depressive Symptoms | Transcranial magnetic stimulation Depressive Symptoms | Vagus Nerve Stimulation Depressive Symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013806
UMLS CUI [1,2]
C0086132
UMLS CUI [2,1]
C0436548
UMLS CUI [2,2]
C0086132
UMLS CUI [3,1]
C2350432
UMLS CUI [3,2]
C0086132
have any clinically significant medical or uncontrolled condition or circumstance prior to randomization that could affect participant safety
Descripción

Medical condition Affecting Patient safety | Condition Uncontrolled Affecting Patient safety | Circumstances Uncontrolled Affecting Patient safety

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C0680082
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0392760
UMLS CUI [3,4]
C1113679
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Similar models

Eligibility Major Depressive Disorder NCT01724112

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE
Item
have a diagnosis of major depressive disorder (mdd) without psychotic features as defined in the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr)
boolean
C0743081 (UMLS CUI [1])
Depressive Symptoms Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
have clinically significant depressive symptoms defined by a grid hamd17 total score
boolean
C0086132 (UMLS CUI [1,1])
C3639712 (UMLS CUI [1,2])
ID.3
Item
≥20 at screening
boolean
Body mass index
Item
body mass index (bmi) between 18 and 35 kilogram per square meter (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bipolar I disorder | Bipolar II disorder | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE | Schizoaffective Disorder | Schizophrenia | Psychotic Disorders
Item
have a current or previous diagnosis of bipolar i or ii disorder, mdd with psychotic features, schizoaffective disorder, schizophrenia, or other psychotic disorder
boolean
C0853193 (UMLS CUI [1])
C0236788 (UMLS CUI [2])
C0743080 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
Depressive Disorder, Treatment-Resistant | Antidepressant therapy Quantity failed | Depressive episode
Item
currently meeting the criteria of treatment-resistant depression defined as ≥2 documented, failed treatment trials of adequate dose and duration with a registered antidepressant during the current depressive episode
boolean
C2063866 (UMLS CUI [1])
C1096649 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0349217 (UMLS CUI [3])
Electroconvulsive Therapy Depressive Symptoms | Transcranial magnetic stimulation Depressive Symptoms | Vagus Nerve Stimulation Depressive Symptoms
Item
had electroconvulsive treatment, transcranial magnetic stimulation, vagal nerve stimulation for symptoms of depression in the 6 months prior to screening
boolean
C0013806 (UMLS CUI [1,1])
C0086132 (UMLS CUI [1,2])
C0436548 (UMLS CUI [2,1])
C0086132 (UMLS CUI [2,2])
C2350432 (UMLS CUI [3,1])
C0086132 (UMLS CUI [3,2])
Medical condition Affecting Patient safety | Condition Uncontrolled Affecting Patient safety | Circumstances Uncontrolled Affecting Patient safety
Item
have any clinically significant medical or uncontrolled condition or circumstance prior to randomization that could affect participant safety
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0680082 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C1113679 (UMLS CUI [3,4])
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