ID

18030

Description

PUFA Augmentation in Treatment of Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00067301

Link

https://clinicaltrials.gov/show/NCT00067301

Keywords

Versions (1)
  1. 10/16/16 10/16/16 -
Uploaded on

October 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depression NCT00067301

English

Eligibility Major Depression NCT00067301

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet dsm-iv criteria for current major depression, and have a ham-d (21 item) score of > 17
Description

Major Depressive Disorder | Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0451203
male or female who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devices, barrier methods or abstinence
Description

Childbearing Potential Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Contraception, Barrier | Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
age between 18 and 65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
capable of giving informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders
Description

Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder | Schizotypal disorder | Depression, psychotic | Bipolar Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036358
UMLS CUI [3]
C0036337
UMLS CUI [4]
C1443045
UMLS CUI [5]
C0743072
UMLS CUI [6]
C0005586
current drug or alcohol abuse or dependence, or history of drug or alcohol abuse or dependence within the previous 6 months
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
unstable medical or neurological conditions that are likely to interfere with the treatment of depression
Description

medical condition Unstable Interferes with Therapeutic procedure Depressive disorder | Condition Neurologic Unstable Interferes with Therapeutic procedure Depressive disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0011581
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205494
UMLS CUI [2,3]
C0443343
UMLS CUI [2,4]
C0521102
UMLS CUI [2,5]
C0087111
UMLS CUI [2,6]
C0011581
history of allergy to citalopram or proepa, finfish or shellfish
Description

Hypersensitivity Citalopram | Hypersensitivity Proepa | Hypersensitivity Finfish | Hypersensitivity Shellfish

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0008845
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0722823
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0016163
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1304606
history of failure of response to citalopram, as documented by an adequate trial of the medication [defined as having been treated with the medication at a dose level typically regarded as adequate (i.e., 40 mg of citalopram per day) for at least 6 weeks]
Description

Citalopram Dosage Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0008845
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205269
history of seizure disorder
Description

Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0014544
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
currently on psychotropic medications including antidepressants or neuroleptics
Description

Psychotropic Drugs | Antidepressive Agents | Antipsychotic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0040615
active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study
Description

Feeling suicidal | Safety Problem

Data type

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2,1]
C0036043
UMLS CUI [2,2]
C0033213
exposure to treatment with fluoxetine or maois in the previous two months
Description

Fluoxetine Exposure to | Monoamine Oxidase Inhibitors Exposure to

Data type

boolean

Alias
UMLS CUI [1,1]
C0016365
UMLS CUI [1,2]
C0332157
UMLS CUI [2,1]
C0026457
UMLS CUI [2,2]
C0332157
patients on anticoagulant therapy
Description

Anticoagulant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0150457
patients with a dietary intake of > 3.0g total omega-3 pufa/day at baseline
Description

Omega-3 Fatty Acids Total Dietary intake

Data type

boolean

Alias
UMLS CUI [1,1]
C0015689
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C1286104
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Similar models

Eligibility Major Depression NCT00067301

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder | Hamilton rating scale for depression
Item
meet dsm-iv criteria for current major depression, and have a ham-d (21 item) score of > 17
boolean
C1269683 (UMLS CUI [1])
C0451203 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Contraception, Barrier | Sexual Abstinence
Item
male or female who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devices, barrier methods or abstinence
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
Age
Item
age between 18 and 65
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
capable of giving informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder | Schizotypal disorder | Depression, psychotic | Bipolar Disorder
Item
diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders
boolean
C0036341 (UMLS CUI [1])
C0036358 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C1443045 (UMLS CUI [4])
C0743072 (UMLS CUI [5])
C0005586 (UMLS CUI [6])
Substance Use Disorders | Substance Dependence
Item
current drug or alcohol abuse or dependence, or history of drug or alcohol abuse or dependence within the previous 6 months
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
medical condition Unstable Interferes with Therapeutic procedure Depressive disorder | Condition Neurologic Unstable Interferes with Therapeutic procedure Depressive disorder
Item
unstable medical or neurological conditions that are likely to interfere with the treatment of depression
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0011581 (UMLS CUI [1,5])
C0348080 (UMLS CUI [2,1])
C0205494 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C0521102 (UMLS CUI [2,4])
C0087111 (UMLS CUI [2,5])
C0011581 (UMLS CUI [2,6])
Hypersensitivity Citalopram | Hypersensitivity Proepa | Hypersensitivity Finfish | Hypersensitivity Shellfish
Item
history of allergy to citalopram or proepa, finfish or shellfish
boolean
C0020517 (UMLS CUI [1,1])
C0008845 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0722823 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0016163 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1304606 (UMLS CUI [4,2])
Citalopram Dosage Unresponsive to Treatment
Item
history of failure of response to citalopram, as documented by an adequate trial of the medication [defined as having been treated with the medication at a dose level typically regarded as adequate (i.e., 40 mg of citalopram per day) for at least 6 weeks]
boolean
C0008845 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Epilepsy
Item
history of seizure disorder
boolean
C0014544 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Psychotropic Drugs | Antidepressive Agents | Antipsychotic Agents
Item
currently on psychotropic medications including antidepressants or neuroleptics
boolean
C0033978 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
Feeling suicidal | Safety Problem
Item
active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study
boolean
C0424000 (UMLS CUI [1])
C0036043 (UMLS CUI [2,1])
C0033213 (UMLS CUI [2,2])
Fluoxetine Exposure to | Monoamine Oxidase Inhibitors Exposure to
Item
exposure to treatment with fluoxetine or maois in the previous two months
boolean
C0016365 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0026457 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
Anticoagulant therapy
Item
patients on anticoagulant therapy
boolean
C0150457 (UMLS CUI [1])
Omega-3 Fatty Acids Total Dietary intake
Item
patients with a dietary intake of > 3.0g total omega-3 pufa/day at baseline
boolean
C0015689 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C1286104 (UMLS CUI [1,3])
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