ID

33891

Description

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

Keywords

Versions (1)
  1. 1/5/19 1/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT01724112

English

Eligibility Major Depressive Disorder NCT01724112

1 forms  
Inclusion Criteria
Description

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)
Description

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Data type

boolean

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

Depressive Symptoms Hamilton Depression Rating Scale 17 Item Clinical Classification

Data type

boolean

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

ID.3

Data type

boolean

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

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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