ID

36097

Description

A Multicenter, Relapse Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT02288325

Link

https://clinicaltrials.gov/show/NCT02288325

Keywords

Versions (3)
  1. 1/16/19 1/16/19 -
  2. 4/14/19 4/14/19 -
  3. 4/15/19 4/15/19 -
Copyright Holder

Forest Laboratories

Uploaded on

April 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Levomilnacipran Extended Release in Major Depression NCT02288325

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the participant between 18-70 years of age?
Description

Patients should be men and women between 18-70

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Does the patient currently meet the DSM-V criteria for major depressive disorder?
Description

Patients should currently meet the dsm-v criteria for major depressive disorder (mdd)

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C1137105
Does the patient have a depressive episode between 8 weeks and 18 months of length?
Description

the patient must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
Did the patient already have 3 lifetime episodes of MDD (including current one)?
Description

The patient must have at least 3 lifetime episodes of mdd (including the current episode)

Data type

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C4086638
UMLS CUI [1,3]
C4071830
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Is the participant pregnant, will be breastfeeding during the study or does not practice a reliable method of birth control despite childbearing age?
Description

Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control are to be excluded

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
Is the patient at risk for suicide?
Description

Patients who are considered at risk for suicide

Data type

boolean

Alias
UMLS CUI [1]
C0563664
Does the patient have a history of non-response to 2 or more antidepressants (after adequate treatment)?
Description

Patients with a history of non-response to 2 or more antidepressants (after adequate treatment) are to be excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3844724
UMLS CUI [1,2]
C0003289
Does the patient meet DSM-V criteria for a manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorders?
Description

Patients who have a history of meeting the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for manic, hypomanic, or mixed episodes obsessive-compulsive disorder, schizophrenia or other psychotic disorders should be excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0349208
UMLS CUI [1,2]
C0220952
UMLS CUI [1,3]
C0243161
UMLS CUI [2,1]
C1396834
UMLS CUI [2,2]
C0220952
UMLS CUI [2,3]
C0243161
UMLS CUI [3,1]
C1608433
UMLS CUI [3,2]
C0220952
UMLS CUI [3,3]
C0243161
UMLS CUI [4,1]
C0028768
UMLS CUI [4,2]
C0220952
UMLS CUI [4,3]
C0243161
UMLS CUI [5,1]
C0036341
UMLS CUI [5,2]
C0220952
UMLS CUI [5,3]
C0243161
UMLS CUI [6,1]
C0033975
UMLS CUI [6,2]
C0220952
UMLS CUI [6,3]
C0243161
Does the patient have a panic disorder?
Description

Panic Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0030319
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Is the participant between 18-70 years of age?
boolean
C0001779 (UMLS CUI [1])
DSM-V Criteria Major Depressive Disorder
Item
Does the patient currently meet the DSM-V criteria for major depressive disorder?
boolean
C1269683 (UMLS CUI [1,1])
C1137105 (UMLS CUI [1,2])
Length of depressive episode
Item
Does the patient have a depressive episode between 8 weeks and 18 months of length?
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Number of depressive episodes
Item
Did the patient already have 3 lifetime episodes of MDD (including current one)?
boolean
C0349217 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
C4071830 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Possibility of pregnancy or breastfeeding
Item
Is the participant pregnant, will be breastfeeding during the study or does not practice a reliable method of birth control despite childbearing age?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Suicide risk
Item
Is the patient at risk for suicide?
boolean
C0563664 (UMLS CUI [1])
Non-Responsive to antidepressants
Item
Does the patient have a history of non-response to 2 or more antidepressants (after adequate treatment)?
boolean
C3844724 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
DSM-V criteria for Bipolar, Schizophrenia or OCD
Item
Does the patient meet DSM-V criteria for a manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorders?
boolean
C0349208 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C1396834 (UMLS CUI [2,1])
C0220952 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,3])
C1608433 (UMLS CUI [3,1])
C0220952 (UMLS CUI [3,2])
C0243161 (UMLS CUI [3,3])
C0028768 (UMLS CUI [4,1])
C0220952 (UMLS CUI [4,2])
C0243161 (UMLS CUI [4,3])
C0036341 (UMLS CUI [5,1])
C0220952 (UMLS CUI [5,2])
C0243161 (UMLS CUI [5,3])
C0033975 (UMLS CUI [6,1])
C0220952 (UMLS CUI [6,2])
C0243161 (UMLS CUI [6,3])
Panic Disorder
Item
Does the patient have a panic disorder?
boolean
C0030319 (UMLS CUI [1])
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