ID

28919

Beskrivning

The Role Of Omega-3 Fatty Acids In Adolescent Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00962598

Länk

https://clinicaltrials.gov/show/NCT00962598

Nyckelord

Versioner (1)
  1. 2018-02-16 2018-02-16 -
Rättsinnehavare

See clinicaltrials.gov

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16 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT00962598

Engelsk

Eligibility Depressive Disorder, Major NCT00962598

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
12 to 19 years old (inclusive) of both sexes and all ethnic/racial groups.
Beskrivning

Age | Ethnic group All

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0015031
UMLS CUI [2,2]
C0444868
dsm-iv-tr criteria for mdd
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
mdd duration of at least 8 weeks and a severity score of at least 40 on the cdrs-r.
Beskrivning

Major Depressive Disorder Duration | MDD Depression in children Rating scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C3826462
UMLS CUI [2,3]
C0681889
age at first onset mdd of at least 12 years.
Beskrivning

Age | MDD Onset First

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0332162
UMLS CUI [2,3]
C0205435
no significant medical or neurological disorder
Beskrivning

Disease Significant Absent | Nervous system disorder Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0332197
for female subjects, negative pregnancy test at time of enrollment.
Beskrivning

Gender | Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0427780
female subjects who are sexually active and not using a method of birth control will be excluded. use of hormonal contraceptives (such as prescribed "birth control pills" or a prescribed birth control implant) is not exclusionary.
Beskrivning

Gender | Contraceptives, Oral, Hormonal | Contraceptives, Oral | Subdermal Birth Control Implant | Exclusion Sexually active Contraceptive methods Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0009907
UMLS CUI [3]
C0009905
UMLS CUI [4]
C2985332
UMLS CUI [5,1]
C2828389
UMLS CUI [5,2]
C0241028
UMLS CUI [5,3]
C0700589
UMLS CUI [5,4]
C0332268
subjects must be able to swallow capsules.
Beskrivning

Able to swallow Capsules

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
a minimum iq of 80 will be required.
Beskrivning

Intelligence quotient Minimum Requirement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0456149
UMLS CUI [1,2]
C1524031
UMLS CUI [1,3]
C1514873
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or past dsm-iv-tr diagnoses of bipolar disorder, schizophrenia, psychosis, autism/pervasive developmental disorder (pdd), and tourette's disorder (td).
Beskrivning

Bipolar Disorder | Schizophrenia | Psychotic Disorders | Autistic Disorder | Pervasive Development Disorder | Gilles de la Tourette syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0004352
UMLS CUI [5]
C0524528
UMLS CUI [6]
C0040517
current diagnosis of eating disorder, panic disorder, obsessive-compulsive disorder (ocd), post traumatic stress disorder (ptsd), conduct disorder, and substance related disorders other than nicotine.
Beskrivning

Eating Disorders | Panic Disorder | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Conduct Disorder | Substance Use Disorders | Exception Nicotine abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0013473
UMLS CUI [2]
C0030319
UMLS CUI [3]
C0028768
UMLS CUI [4]
C0038436
UMLS CUI [5]
C0149654
UMLS CUI [6]
C0038586
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C2363943
current suicidal ideation with intent or plan, or who may pose a danger to themselves.
Beskrivning

Feeling suicidal | Suicidal intent | Planning suicide | DANGER OF HARM TO SELF

Datatyp

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0582496
UMLS CUI [3]
C0424001
UMLS CUI [4]
C0149660
current antidepressant treatment will be excluded. past antidepressant treatment will not be exclusionary, so long as patients are off antidepressant medication for 60 days prior to study entry. no individual will be advised to terminate ongoing treatment.
Beskrivning

Antidepressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003289
certain short half-life medications, such as vitamins that contain unidentified ingredients, st. johns wort, s-adenosyl methionine (sam), clonidine, and some over-the-counter medications.
Beskrivning

Pharmaceutical Preparations Half-Life Short | Vitamins Containing Ingredient Unidentified | Hypericum perforatum | S-Adenosylmethionine | Clonidine | Non-Prescription Drugs Some

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0018517
UMLS CUI [1,3]
C1806781
UMLS CUI [2,1]
C0042890
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C1550600
UMLS CUI [2,4]
C0205427
UMLS CUI [3]
C0936242
UMLS CUI [4]
C0036002
UMLS CUI [5]
C0009014
UMLS CUI [6,1]
C0013231
UMLS CUI [6,2]
C0205392
a minimum of 90 days off of treatment with long half life medications, such as neuroleptics, prior to study entry is required. stimulant medication treatment for adhd will not be exclusionary.
Beskrivning

Pharmaceutical Preparations Half-Life Long | Antipsychotic Agents | Stimulant ADHD Acceptable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0018517
UMLS CUI [1,3]
C0205166
UMLS CUI [2]
C0040615
UMLS CUI [3,1]
C0304402
UMLS CUI [3,2]
C1263846
UMLS CUI [3,3]
C1879533
if adolescents have been in psychotherapy prior to their entry in the study, they will be allowed to continue with the treatment. however, psychotherapy cannot be initiated at the time of study entry.
Beskrivning

Psychotherapy Started | Psychotherapy Previous Continue allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C1272689
UMLS CUI [2,1]
C0033968
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0549178
UMLS CUI [2,4]
C0683607
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Similar models

Eligibility Depressive Disorder, Major NCT00962598

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Ethnic group All
Item
12 to 19 years old (inclusive) of both sexes and all ethnic/racial groups.
boolean
C0001779 (UMLS CUI [1])
C0015031 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Major Depressive Disorder
Item
dsm-iv-tr criteria for mdd
boolean
C1269683 (UMLS CUI [1])
Major Depressive Disorder Duration | MDD Depression in children Rating scale
Item
mdd duration of at least 8 weeks and a severity score of at least 40 on the cdrs-r.
boolean
C1269683 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1269683 (UMLS CUI [2,1])
C3826462 (UMLS CUI [2,2])
C0681889 (UMLS CUI [2,3])
Age | MDD Onset First
Item
age at first onset mdd of at least 12 years.
boolean
C0001779 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
Disease Significant Absent | Nervous system disorder Absent
Item
no significant medical or neurological disorder
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Gender | Pregnancy test negative
Item
for female subjects, negative pregnancy test at time of enrollment.
boolean
C0079399 (UMLS CUI [1])
C0427780 (UMLS CUI [2])
Gender | Contraceptives, Oral, Hormonal | Contraceptives, Oral | Subdermal Birth Control Implant | Exclusion Sexually active Contraceptive methods Lacking
Item
female subjects who are sexually active and not using a method of birth control will be excluded. use of hormonal contraceptives (such as prescribed "birth control pills" or a prescribed birth control implant) is not exclusionary.
boolean
C0079399 (UMLS CUI [1])
C0009907 (UMLS CUI [2])
C0009905 (UMLS CUI [3])
C2985332 (UMLS CUI [4])
C2828389 (UMLS CUI [5,1])
C0241028 (UMLS CUI [5,2])
C0700589 (UMLS CUI [5,3])
C0332268 (UMLS CUI [5,4])
Able to swallow Capsules
Item
subjects must be able to swallow capsules.
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Intelligence quotient Minimum Requirement
Item
a minimum iq of 80 will be required.
boolean
C0456149 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Bipolar Disorder | Schizophrenia | Psychotic Disorders | Autistic Disorder | Pervasive Development Disorder | Gilles de la Tourette syndrome
Item
current or past dsm-iv-tr diagnoses of bipolar disorder, schizophrenia, psychosis, autism/pervasive developmental disorder (pdd), and tourette's disorder (td).
boolean
C0005586 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0004352 (UMLS CUI [4])
C0524528 (UMLS CUI [5])
C0040517 (UMLS CUI [6])
Eating Disorders | Panic Disorder | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Conduct Disorder | Substance Use Disorders | Exception Nicotine abuse
Item
current diagnosis of eating disorder, panic disorder, obsessive-compulsive disorder (ocd), post traumatic stress disorder (ptsd), conduct disorder, and substance related disorders other than nicotine.
boolean
C0013473 (UMLS CUI [1])
C0030319 (UMLS CUI [2])
C0028768 (UMLS CUI [3])
C0038436 (UMLS CUI [4])
C0149654 (UMLS CUI [5])
C0038586 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C2363943 (UMLS CUI [7,2])
Feeling suicidal | Suicidal intent | Planning suicide | DANGER OF HARM TO SELF
Item
current suicidal ideation with intent or plan, or who may pose a danger to themselves.
boolean
C0424000 (UMLS CUI [1])
C0582496 (UMLS CUI [2])
C0424001 (UMLS CUI [3])
C0149660 (UMLS CUI [4])
Antidepressive Agents
Item
current antidepressant treatment will be excluded. past antidepressant treatment will not be exclusionary, so long as patients are off antidepressant medication for 60 days prior to study entry. no individual will be advised to terminate ongoing treatment.
boolean
C0003289 (UMLS CUI [1])
Pharmaceutical Preparations Half-Life Short | Vitamins Containing Ingredient Unidentified | Hypericum perforatum | S-Adenosylmethionine | Clonidine | Non-Prescription Drugs Some
Item
certain short half-life medications, such as vitamins that contain unidentified ingredients, st. johns wort, s-adenosyl methionine (sam), clonidine, and some over-the-counter medications.
boolean
C0013227 (UMLS CUI [1,1])
C0018517 (UMLS CUI [1,2])
C1806781 (UMLS CUI [1,3])
C0042890 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
C0205427 (UMLS CUI [2,4])
C0936242 (UMLS CUI [3])
C0036002 (UMLS CUI [4])
C0009014 (UMLS CUI [5])
C0013231 (UMLS CUI [6,1])
C0205392 (UMLS CUI [6,2])
Pharmaceutical Preparations Half-Life Long | Antipsychotic Agents | Stimulant ADHD Acceptable
Item
a minimum of 90 days off of treatment with long half life medications, such as neuroleptics, prior to study entry is required. stimulant medication treatment for adhd will not be exclusionary.
boolean
C0013227 (UMLS CUI [1,1])
C0018517 (UMLS CUI [1,2])
C0205166 (UMLS CUI [1,3])
C0040615 (UMLS CUI [2])
C0304402 (UMLS CUI [3,1])
C1263846 (UMLS CUI [3,2])
C1879533 (UMLS CUI [3,3])
Psychotherapy Started | Psychotherapy Previous Continue allowed
Item
if adolescents have been in psychotherapy prior to their entry in the study, they will be allowed to continue with the treatment. however, psychotherapy cannot be initiated at the time of study entry.
boolean
C0033968 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0033968 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0549178 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
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