ID

21763

Description

A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00289484

Link

https://clinicaltrials.gov/show/NCT00289484

Keywords

Versions (1)
  1. 4/28/17 4/28/17 -
Uploaded on

April 28, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depression NCT00289484

English

Eligibility Major Depression NCT00289484

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must present with a first or new episode of dsm iv non-psychotic major depression warranting treatment with antidepressant mediation.
Description

Single major depressive episode First | Single major depressive episode New | Antidepressant therapy Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0205435
UMLS CUI [2,1]
C0024517
UMLS CUI [2,2]
C0205314
UMLS CUI [3,1]
C1096649
UMLS CUI [3,2]
C0686904
must be able to give informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of psychosis or mania/hypomania or personality disorder.
Description

Psychotic Disorder | Manic Disorder | Hypomania | Personality Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0024713
UMLS CUI [3]
C0241934
UMLS CUI [4]
C0031212
non-english speaking or otherwise unable to provide historical information.
Description

Able to speak English Language | History of present illness Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0262512
UMLS CUI [2,2]
C0332268
having taken omega-3 dietary supplements in the last 3 months.
Description

Omega-3 Fatty Acids Dietary Supplements

Data type

boolean

Alias
UMLS CUI [1,1]
C0015689
UMLS CUI [1,2]
C0242295
history of allergy to omega-3 supplements, finfish or shellfish.
Description

Hypersensitivity Omega-3 Fatty Acids Supplements | Hypersensitivity Finfish | Shellfish allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0015689
UMLS CUI [1,3]
C0242295
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0016163
UMLS CUI [3]
C0577625
pregnancy, breast feeding or plans to become pregnant during course of study.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
post-natal depression
Description

Depression, Postpartum

Data type

boolean

Alias
UMLS CUI [1]
C0221074
current drug or alcohol abuse or dependence or history of abuse or dependence over the last 12 months.
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
unstable thyroid function
Description

Thyroid function Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C2242456
UMLS CUI [1,2]
C0443343
hepatic or renal impairment or other medical conditions that may interfere with the absorption and metabolism of omega-3 polyunsaturated fatty acids
Description

Hepatic impairment | Renal Insufficiency | Medical condition Interferes with Absorption Omega-3 Fatty Acids | Medical condition Interferes with Metabolism Omega-3 Fatty Acids

Data type

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1565489
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0237442
UMLS CUI [3,4]
C0015689
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0025519
UMLS CUI [4,4]
C0015689
coagulopathy or anticoagulant treatment due to theoretical bleeding risk.
Description

Blood Coagulation Disorders | Anticoagulant therapy Due to Bleeding Risk

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C0150457
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C3251812
patients who, in the investigator's judgment pose a current serious suicidal or other safety risk, or patients who will not likely be able to comply with the study protocol.
Description

High suicide risk | Patient safety Risk Serious | Protocol Compliance Unlikely

Data type

boolean

Alias
UMLS CUI [1]
C1271074
UMLS CUI [2,1]
C1113679
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0205404
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0750558
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Similar models

Eligibility Major Depression NCT00289484

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Single major depressive episode First | Single major depressive episode New | Antidepressant therapy Patient need for
Item
participants must present with a first or new episode of dsm iv non-psychotic major depression warranting treatment with antidepressant mediation.
boolean
C0024517 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0024517 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1096649 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Informed Consent
Item
must be able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Psychotic Disorder | Manic Disorder | Hypomania | Personality Disorder
Item
history of psychosis or mania/hypomania or personality disorder.
boolean
C0033975 (UMLS CUI [1])
C0024713 (UMLS CUI [2])
C0241934 (UMLS CUI [3])
C0031212 (UMLS CUI [4])
Able to speak English Language | History of present illness Lacking
Item
non-english speaking or otherwise unable to provide historical information.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0262512 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Omega-3 Fatty Acids Dietary Supplements
Item
having taken omega-3 dietary supplements in the last 3 months.
boolean
C0015689 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
Hypersensitivity Omega-3 Fatty Acids Supplements | Hypersensitivity Finfish | Shellfish allergy
Item
history of allergy to omega-3 supplements, finfish or shellfish.
boolean
C0020517 (UMLS CUI [1,1])
C0015689 (UMLS CUI [1,2])
C0242295 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0016163 (UMLS CUI [2,2])
C0577625 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnancy, breast feeding or plans to become pregnant during course of study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Depression, Postpartum
Item
post-natal depression
boolean
C0221074 (UMLS CUI [1])
Substance Use Disorders | Substance Dependence
Item
current drug or alcohol abuse or dependence or history of abuse or dependence over the last 12 months.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Thyroid function Unstable
Item
unstable thyroid function
boolean
C2242456 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Hepatic impairment | Renal Insufficiency | Medical condition Interferes with Absorption Omega-3 Fatty Acids | Medical condition Interferes with Metabolism Omega-3 Fatty Acids
Item
hepatic or renal impairment or other medical conditions that may interfere with the absorption and metabolism of omega-3 polyunsaturated fatty acids
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0237442 (UMLS CUI [3,3])
C0015689 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0025519 (UMLS CUI [4,3])
C0015689 (UMLS CUI [4,4])
Blood Coagulation Disorders | Anticoagulant therapy Due to Bleeding Risk
Item
coagulopathy or anticoagulant treatment due to theoretical bleeding risk.
boolean
C0005779 (UMLS CUI [1])
C0150457 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C3251812 (UMLS CUI [2,3])
High suicide risk | Patient safety Risk Serious | Protocol Compliance Unlikely
Item
patients who, in the investigator's judgment pose a current serious suicidal or other safety risk, or patients who will not likely be able to comply with the study protocol.
boolean
C1271074 (UMLS CUI [1])
C1113679 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C0525058 (UMLS CUI [3,1])
C0750558 (UMLS CUI [3,2])
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