ID

17108

Description

Effects of Tryptophan Depletion on Brain Processing of Emotions in Patients With Mood Disorders; ODM derived from: https://clinicaltrials.gov/show/NCT00097175

Link

https://clinicaltrials.gov/show/NCT00097175

Keywords

Versions (2)
  1. 8/25/16 8/25/16 -
  2. 8/25/16 8/25/16 -
Uploaded on

August 25, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Depressive Disorder, Major NCT00097175

English

Eligibility Depressive Disorder, Major NCT00097175

1 forms  
Criteria
Description

Criteria

healthy volunteers
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
right-handed subjects (ages 18-50) will be selected who have not met criteria for any major psychiatric disorder, have no known first-degree relatives with mood disorders, and have a current score on the hamilton depression rating scale (hdrs; 17 item) in the not depressed range ( 7). control subjects will be matched to depressed subjects and their relatives for age, gender, and education.
Description

Handedness | Age | Mental disorders Major | Mood Disorders First Degree Relative | Hamilton rating scale for depression | Gender | Education

Data type

boolean

Alias
UMLS CUI [1]
C0023114
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205164
UMLS CUI [4,1]
C0525045
UMLS CUI [4,2]
C1517194
UMLS CUI [5]
C0451203
UMLS CUI [6]
C0079399
UMLS CUI [7]
C0013622
mdd samples
Description

Major Depressive Disorder Volunteer Sample

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0150095
right-handed subjects (ages 18-50) will be selected with a past history of mdd by dsm-iv criteria.
Description

Handedness | Age | Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0023114
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1269683
healthy relatives
Description

Relative Healthy

Data type

boolean

Alias
UMLS CUI [1,1]
C0080103
UMLS CUI [1,2]
C3898900
healthy, right-handed, first-degree relatives of patients with mdd will be recruited.
Description

Healthy Volunteers | Handedness | First Degree Relative | Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0023114
UMLS CUI [3]
C1517194
UMLS CUI [4]
C1269683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects must not have taken antidepressant drugs for at least 3 months (4 months for fluoxetine) prior to the fmri studies or other medications likely to alter monoamine neurochemistry or cerebrovascular and cardiovascular function for at least 3 weeks prior to imaging. however, effective medications will not be discontinued for the purposes of this study. subjects will also be excluded if they have:
Description

Antidepressive Agents | Fluoxetine | fMRI | Pharmaceutical Preparations Changing monoamine Neurochemistry | Pharmaceutical Preparations Changing Function Cerebrovascular | Pharmaceutical Preparations Changing cardiovascular function | Imaging | Pharmaceutical Preparations Effective Discontinue

Data type

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0016365
UMLS CUI [3]
C0376335
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C0599682
UMLS CUI [4,4]
C0699841
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0392747
UMLS CUI [5,3]
C0031843
UMLS CUI [5,4]
C1880018
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0392747
UMLS CUI [6,3]
C0007227
UMLS CUI [7]
C0011923
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C1280519
UMLS CUI [8,3]
C1444662
1. psychosis
Description

Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0033975
2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. hypertension, cardiovascular disorders
Description

Illness Affecting physiology | Illness Affecting Anatomy | nervous system disorder Affecting physiology | nervous system disorder Affecting Anatomy | Hypertensive disease | Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0031843
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1384516
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0031843
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1384516
UMLS CUI [5]
C0020538
UMLS CUI [6]
C0007222
3. a history of drug (including benzodiazepines (bzd)) abuse within 1 year or a lifetime history of drug dependence (dsm iv criteria)
Description

Drug abuse | Benzodiazepines | Drug Dependence Lifetime

Data type

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0005064
UMLS CUI [3,1]
C1510472
UMLS CUI [3,2]
C4071830
4. a history of alcohol abuse within 1 year or a lifetime history of alcohol dependence (dsm iv criteria)
Description

Alcohol abuse | Alcohol dependence Lifetime

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2,1]
C0001973
UMLS CUI [2,2]
C4071830
5. current pregnancy (as documented by pregnancy testing at screening or at days of the challenge studies)
Description

Pregnancy Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0032976
6. current breast feeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
7. are smokers
Description

Smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337664
8. serious suicidal ideation or behavior. in this study, there is a small risk of transient depressive symptoms occurring after ingesting the amino acid mixture. therefore, if volunteers manifest evidence of serious suicidal ideation or behavior, they will be excluded from participating. criteria for meeting suicidal ideation include but are not limited to: 1) thoughts of suicide within the past 3 months which are accompanied by intent to harm oneself, serious consideration of means or plan to attempt suicide, evidence of arranging for a suicide attempt (e.g. giving away prized possessions or updating a will), or clear desire to commit suicide, 2) severity of past suicide events, if applicable or 3) a current plan for harming themselves. all assessments will be conducted by an experienced, nimh credentialed health professional, such as a psychiatrist or psychiatric nurse who will use their expert knowledge and experiences in determining the authenticity of a participant s information and handle the situation accordingly.
Description

Feeling suicidal Serious | Suicidal behavior Serious | Low Risk Depressive Symptoms transient | Amino Acids Mixture | Suicide attempt Severity | Thoughts of self harm | Suicide attempt Planned | Planning suicide

Data type

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1760428
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C3538919
UMLS CUI [3,2]
C0086132
UMLS CUI [3,3]
C0205374
UMLS CUI [4,1]
C0002520
UMLS CUI [4,2]
C0439962
UMLS CUI [5,1]
C0038663
UMLS CUI [5,2]
C0439793
UMLS CUI [6]
C0522178
UMLS CUI [7,1]
C0038663
UMLS CUI [7,2]
C1301732
UMLS CUI [8]
C0424001
9. general mri exclusion criteria
Description

Exclusion Criteria MRI General

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0205246
subjects must exhibit no or only moderate alcohol use. subjects with current or previous regular use (greater than 4 weeks) of bzds and excessive use of alcohol (greater than 8 ounces/day for men and greater than 6 ounces/day for women) in the past or present are ineligible for participation, as such drug use may confound the results. smokers (regular use within the last 3 months) are ineligible because of the evidence for interactions between nicotine and depression, and the possibility of withdrawal symptoms that may affect behavioral and neural responses to td.
Description

Alcohol consumption | Alcohol consumption Moderate | Benzodiazepines Use Regular | Alcohol intake above recommended sensible limits | Gender | Drug usage Interferes with research results | Smoker | Nicotine Interaction Depressive disorder | Withdrawal Symptoms | behavioral response to nicotine | Tobacco Dependence Response neural

Data type

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0005064
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0205272
UMLS CUI [4]
C0560219
UMLS CUI [5]
C0079399
UMLS CUI [6,1]
C0242510
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0683954
UMLS CUI [7]
C0337664
UMLS CUI [8,1]
C0028040
UMLS CUI [8,2]
C1704675
UMLS CUI [8,3]
C0011581
UMLS CUI [9]
C0087169
UMLS CUI [10]
C1325839
UMLS CUI [11,1]
C0040332
UMLS CUI [11,2]
C0871261
UMLS CUI [11,3]
C3714606
subjects beyond age 50 are excluded to address the biological heterogeneity encompassed by the mdd criteria, since depressives whose age-at-onset is later than 50 have a far greater likelihood of having mri correlates of cerebrovascular disease than age-matched healthy controls or age-matched early-onset depressives. subjects whose first major depressive episodes arose temporally after other medical or psychiatric conditions will also be excluded, since their functional imaging results generally differ from those reported in primary mdd.
Description

Age | Heterogeneity biological | Major Depressive Disorder criteria | Magnetic Resonance Imaging | Cerebrovascular Disorders | Single major depressive episode | medical condition | Mental disorders | Functional Imaging | Major Depressive Disorder Primary

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0019409
UMLS CUI [2,2]
C0205460
UMLS CUI [3,1]
C1269683
UMLS CUI [3,2]
C0243161
UMLS CUI [4]
C0024485
UMLS CUI [5]
C0007820
UMLS CUI [6]
C0024517
UMLS CUI [7]
C3843040
UMLS CUI [8]
C0004936
UMLS CUI [9]
C1517324
UMLS CUI [10,1]
C1269683
UMLS CUI [10,2]
C0205225
Back to the top of the page

Similar models

Eligibility Depressive Disorder, Major NCT00097175

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Healthy Volunteers
Item
healthy volunteers
boolean
C1708335 (UMLS CUI [1])
Handedness | Age | Mental disorders Major | Mood Disorders First Degree Relative | Hamilton rating scale for depression | Gender | Education
Item
right-handed subjects (ages 18-50) will be selected who have not met criteria for any major psychiatric disorder, have no known first-degree relatives with mood disorders, and have a current score on the hamilton depression rating scale (hdrs; 17 item) in the not depressed range ( 7). control subjects will be matched to depressed subjects and their relatives for age, gender, and education.
boolean
C0023114 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0004936 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0525045 (UMLS CUI [4,1])
C1517194 (UMLS CUI [4,2])
C0451203 (UMLS CUI [5])
C0079399 (UMLS CUI [6])
C0013622 (UMLS CUI [7])
Major Depressive Disorder Volunteer Sample
Item
mdd samples
boolean
C1269683 (UMLS CUI [1,1])
C0150095 (UMLS CUI [1,2])
Handedness | Age | Major Depressive Disorder
Item
right-handed subjects (ages 18-50) will be selected with a past history of mdd by dsm-iv criteria.
boolean
C0023114 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1269683 (UMLS CUI [3])
Relative Healthy
Item
healthy relatives
boolean
C0080103 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
Healthy Volunteers | Handedness | First Degree Relative | Major Depressive Disorder
Item
healthy, right-handed, first-degree relatives of patients with mdd will be recruited.
boolean
C1708335 (UMLS CUI [1])
C0023114 (UMLS CUI [2])
C1517194 (UMLS CUI [3])
C1269683 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Antidepressive Agents | Fluoxetine | fMRI | Pharmaceutical Preparations Changing monoamine Neurochemistry | Pharmaceutical Preparations Changing Function Cerebrovascular | Pharmaceutical Preparations Changing cardiovascular function | Imaging | Pharmaceutical Preparations Effective Discontinue
Item
subjects must not have taken antidepressant drugs for at least 3 months (4 months for fluoxetine) prior to the fmri studies or other medications likely to alter monoamine neurochemistry or cerebrovascular and cardiovascular function for at least 3 weeks prior to imaging. however, effective medications will not be discontinued for the purposes of this study. subjects will also be excluded if they have:
boolean
C0003289 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0376335 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0599682 (UMLS CUI [4,3])
C0699841 (UMLS CUI [4,4])
C0013227 (UMLS CUI [5,1])
C0392747 (UMLS CUI [5,2])
C0031843 (UMLS CUI [5,3])
C1880018 (UMLS CUI [5,4])
C0013227 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
C0007227 (UMLS CUI [6,3])
C0011923 (UMLS CUI [7])
C0013227 (UMLS CUI [8,1])
C1280519 (UMLS CUI [8,2])
C1444662 (UMLS CUI [8,3])
Psychotic Disorders
Item
1. psychosis
boolean
C0033975 (UMLS CUI [1])
Illness Affecting physiology | Illness Affecting Anatomy | nervous system disorder Affecting physiology | nervous system disorder Affecting Anatomy | Hypertensive disease | Cardiovascular Diseases
Item
2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. hypertension, cardiovascular disorders
boolean
C0221423 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1384516 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0031843 (UMLS CUI [3,3])
C0027765 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1384516 (UMLS CUI [4,3])
C0020538 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
Drug abuse | Benzodiazepines | Drug Dependence Lifetime
Item
3. a history of drug (including benzodiazepines (bzd)) abuse within 1 year or a lifetime history of drug dependence (dsm iv criteria)
boolean
C0013146 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C1510472 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
Alcohol abuse | Alcohol dependence Lifetime
Item
4. a history of alcohol abuse within 1 year or a lifetime history of alcohol dependence (dsm iv criteria)
boolean
C0085762 (UMLS CUI [1])
C0001973 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
Pregnancy Pregnancy Test
Item
5. current pregnancy (as documented by pregnancy testing at screening or at days of the challenge studies)
boolean
C0032961 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Breast Feeding
Item
6. current breast feeding
boolean
C0006147 (UMLS CUI [1])
Smoker
Item
7. are smokers
boolean
C0337664 (UMLS CUI [1])
Feeling suicidal Serious | Suicidal behavior Serious | Low Risk Depressive Symptoms transient | Amino Acids Mixture | Suicide attempt Severity | Thoughts of self harm | Suicide attempt Planned | Planning suicide
Item
8. serious suicidal ideation or behavior. in this study, there is a small risk of transient depressive symptoms occurring after ingesting the amino acid mixture. therefore, if volunteers manifest evidence of serious suicidal ideation or behavior, they will be excluded from participating. criteria for meeting suicidal ideation include but are not limited to: 1) thoughts of suicide within the past 3 months which are accompanied by intent to harm oneself, serious consideration of means or plan to attempt suicide, evidence of arranging for a suicide attempt (e.g. giving away prized possessions or updating a will), or clear desire to commit suicide, 2) severity of past suicide events, if applicable or 3) a current plan for harming themselves. all assessments will be conducted by an experienced, nimh credentialed health professional, such as a psychiatrist or psychiatric nurse who will use their expert knowledge and experiences in determining the authenticity of a participant s information and handle the situation accordingly.
boolean
C0424000 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1760428 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C3538919 (UMLS CUI [3,1])
C0086132 (UMLS CUI [3,2])
C0205374 (UMLS CUI [3,3])
C0002520 (UMLS CUI [4,1])
C0439962 (UMLS CUI [4,2])
C0038663 (UMLS CUI [5,1])
C0439793 (UMLS CUI [5,2])
C0522178 (UMLS CUI [6])
C0038663 (UMLS CUI [7,1])
C1301732 (UMLS CUI [7,2])
C0424001 (UMLS CUI [8])
Exclusion Criteria MRI General
Item
9. general mri exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
Alcohol consumption | Alcohol consumption Moderate | Benzodiazepines Use Regular | Alcohol intake above recommended sensible limits | Gender | Drug usage Interferes with research results | Smoker | Nicotine Interaction Depressive disorder | Withdrawal Symptoms | behavioral response to nicotine | Tobacco Dependence Response neural
Item
subjects must exhibit no or only moderate alcohol use. subjects with current or previous regular use (greater than 4 weeks) of bzds and excessive use of alcohol (greater than 8 ounces/day for men and greater than 6 ounces/day for women) in the past or present are ineligible for participation, as such drug use may confound the results. smokers (regular use within the last 3 months) are ineligible because of the evidence for interactions between nicotine and depression, and the possibility of withdrawal symptoms that may affect behavioral and neural responses to td.
boolean
C0001948 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0005064 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0205272 (UMLS CUI [3,3])
C0560219 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C0242510 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0683954 (UMLS CUI [6,3])
C0337664 (UMLS CUI [7])
C0028040 (UMLS CUI [8,1])
C1704675 (UMLS CUI [8,2])
C0011581 (UMLS CUI [8,3])
C0087169 (UMLS CUI [9])
C1325839 (UMLS CUI [10])
C0040332 (UMLS CUI [11,1])
C0871261 (UMLS CUI [11,2])
C3714606 (UMLS CUI [11,3])
Age | Heterogeneity biological | Major Depressive Disorder criteria | Magnetic Resonance Imaging | Cerebrovascular Disorders | Single major depressive episode | medical condition | Mental disorders | Functional Imaging | Major Depressive Disorder Primary
Item
subjects beyond age 50 are excluded to address the biological heterogeneity encompassed by the mdd criteria, since depressives whose age-at-onset is later than 50 have a far greater likelihood of having mri correlates of cerebrovascular disease than age-matched healthy controls or age-matched early-onset depressives. subjects whose first major depressive episodes arose temporally after other medical or psychiatric conditions will also be excluded, since their functional imaging results generally differ from those reported in primary mdd.
boolean
C0001779 (UMLS CUI [1])
C0019409 (UMLS CUI [2,1])
C0205460 (UMLS CUI [2,2])
C1269683 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C0024485 (UMLS CUI [4])
C0007820 (UMLS CUI [5])
C0024517 (UMLS CUI [6])
C3843040 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
C1517324 (UMLS CUI [9])
C1269683 (UMLS CUI [10,1])
C0205225 (UMLS CUI [10,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial