ID

28881

Description

Omega-3 for Peri- and Postmenopausal Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00825994

Link

https://clinicaltrials.gov/show/NCT00825994

Keywords

Versions (1)
  1. 2/10/18 2/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00825994

English

Eligibility Depression NCT00825994

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00825994
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women age 40 and older in the peri- or postmenopausal period, as defined in soules et al. 2001
Description

Gender | Age | Perimenopausal state | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C3839366
UMLS CUI [4]
C0232970
meet criteria for major depressive disorder on the mini (mini-international neuropsychiatric interview)
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
score of 18 or greater on madrs (montgomery-asberg depression rating scale) at screening visit
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
do not meet criteria for placebo response during placebo run-in phase; placebo response is defined as a > 50% decrease in madrs from screening to end of placebo run-in phase
Description

Run-in Period Placebo Response Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3274438
UMLS CUI [1,2]
C0032042
UMLS CUI [1,3]
C1704632
UMLS CUI [1,4]
C0332197
willing to receive treatment on an outpatient basis
Description

Therapeutic procedure Outpatient Base Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0029921
UMLS CUI [1,3]
C1705938
UMLS CUI [1,4]
C0600109
presence of general good health
Description

General health good

Data type

boolean

Alias
UMLS CUI [1]
C1277245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently pregnant, trying to conceive, or breastfeeding
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
treatment with an antidepressant medication currently or in the past 1 month
Description

Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0003289
treatment with hormone replacement therapy currently or in the past 1 month
Description

Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0282402
treatment with omega-3 supplements currently or in the past 1 month
Description

Omega-3 Fatty Acids Supplements

Data type

boolean

Alias
UMLS CUI [1,1]
C0015689
UMLS CUI [1,2]
C0242295
use of birth control pills currently or in the past 1 month
Description

Contraceptives, Oral

Data type

boolean

Alias
UMLS CUI [1]
C0009905
presence of suicidal ideation
Description

Feeling suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0424000
meet criteria for current or within the past month for panic disorder, obsessive compulsive disorder (ocd), psychosis, mania or hypomania, as assessed by the mini
Description

Panic Disorder | Obsessive-Compulsive Disorder | Psychotic Disorders | Mania | Hypomania

Data type

boolean

Alias
UMLS CUI [1]
C0030319
UMLS CUI [2]
C0028768
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0338831
UMLS CUI [5]
C0241934
diagnosis of treatment resistant major depressive disorder, defined as patients who have been treated with two or more therapeutic courses of antidepressant medication without remission of symptoms for the current episode of depression, as assessed by the mini
Description

Major Depressive Disorder Unresponsive to Treatment | Antidepressive Agents Course Quantity | Depressive episode Remission Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0349217
UMLS CUI [3,2]
C0544452
UMLS CUI [3,3]
C0332197
any medical condition that would make participation in the study unsafe, as determined by investigator
Description

Medical condition Study Subject Participation Status Unsafe

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C4036038
presence of a known allergy to fish or fish oil that would put participant at risk, as determined by a study investigator
Description

Allergy to fish Study Subject Participation Status At risk | Fish oils allergy Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0856904
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0571871
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
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Similar models

Eligibility Depression NCT00825994

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00825994
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Perimenopausal state | Postmenopausal state
Item
women age 40 and older in the peri- or postmenopausal period, as defined in soules et al. 2001
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3839366 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
Major Depressive Disorder
Item
meet criteria for major depressive disorder on the mini (mini-international neuropsychiatric interview)
boolean
C1269683 (UMLS CUI [1])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
score of 18 or greater on madrs (montgomery-asberg depression rating scale) at screening visit
boolean
C4054475 (UMLS CUI [1])
Run-in Period Placebo Response Absent
Item
do not meet criteria for placebo response during placebo run-in phase; placebo response is defined as a > 50% decrease in madrs from screening to end of placebo run-in phase
boolean
C3274438 (UMLS CUI [1,1])
C0032042 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Therapeutic procedure Outpatient Base Willing
Item
willing to receive treatment on an outpatient basis
boolean
C0087111 (UMLS CUI [1,1])
C0029921 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,4])
General health good
Item
presence of general good health
boolean
C1277245 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
currently pregnant, trying to conceive, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Antidepressive Agents
Item
treatment with an antidepressant medication currently or in the past 1 month
boolean
C0003289 (UMLS CUI [1])
Hormone replacement therapy
Item
treatment with hormone replacement therapy currently or in the past 1 month
boolean
C0282402 (UMLS CUI [1])
Omega-3 Fatty Acids Supplements
Item
treatment with omega-3 supplements currently or in the past 1 month
boolean
C0015689 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
Contraceptives, Oral
Item
use of birth control pills currently or in the past 1 month
boolean
C0009905 (UMLS CUI [1])
Feeling suicidal
Item
presence of suicidal ideation
boolean
C0424000 (UMLS CUI [1])
Panic Disorder | Obsessive-Compulsive Disorder | Psychotic Disorders | Mania | Hypomania
Item
meet criteria for current or within the past month for panic disorder, obsessive compulsive disorder (ocd), psychosis, mania or hypomania, as assessed by the mini
boolean
C0030319 (UMLS CUI [1])
C0028768 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0338831 (UMLS CUI [4])
C0241934 (UMLS CUI [5])
Major Depressive Disorder Unresponsive to Treatment | Antidepressive Agents Course Quantity | Depressive episode Remission Absent
Item
diagnosis of treatment resistant major depressive disorder, defined as patients who have been treated with two or more therapeutic courses of antidepressant medication without remission of symptoms for the current episode of depression, as assessed by the mini
boolean
C1269683 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0349217 (UMLS CUI [3,1])
C0544452 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Medical condition Study Subject Participation Status Unsafe
Item
any medical condition that would make participation in the study unsafe, as determined by investigator
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C4036038 (UMLS CUI [1,3])
Allergy to fish Study Subject Participation Status At risk | Fish oils allergy Study Subject Participation Status At risk
Item
presence of a known allergy to fish or fish oil that would put participant at risk, as determined by a study investigator
boolean
C0856904 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0571871 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
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