0 Evaluaciones

ID

16983

Descripción

Evaluating Brain Responses to Facial Expressions in Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00071123

Link

https://clinicaltrials.gov/show/NCT00071123

Palabras clave

  1. 17/8/16 17/8/16 -
  2. 17/8/16 17/8/16 -
Subido en

17 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Current Major Depressive Disorder NCT00071123

    Eligibility Current Major Depressive Disorder NCT00071123

    Criteria
    Descripción

    Criteria

    healthy volunteers (n=65)
    Descripción

    Healthy Volunteers

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1708335
    healthy control sample (n = 30, phase 1; n = 15, phase 3; n=20, phase 5): right-handed subjects (ages 18-55) 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 (less than or equal to 7). control subjects will be matched to depressed subjects for age, gender, and education.
    Descripción

    Control Group Healthy | Study Subject Right handed | Age | Mental disorders Major | First Degree Relative Mood Disorders | Hamilton rating scale for depression | Gender | Education

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009932
    UMLS CUI [1,2]
    C3898900
    UMLS CUI [2,1]
    C0681850
    UMLS CUI [2,2]
    C0344333
    UMLS CUI [3]
    C0001779
    UMLS CUI [4,1]
    C0004936
    UMLS CUI [4,2]
    C0205164
    UMLS CUI [5,1]
    C1517194
    UMLS CUI [5,2]
    C0525045
    UMLS CUI [6]
    C0451203
    UMLS CUI [7]
    C0079399
    UMLS CUI [8]
    C0013622
    mdd samples (n =80)
    Descripción

    Major Depressive Disorder Volunteer Sample

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1269683
    UMLS CUI [1,2]
    C0150095
    mdd sample-currently depressed (n = 30, phase 1; n = 15, phase 3; n=20, phase 5): right-handed subjects (ages 18-55) will be selected with primary mdd currently depressed by dsm-iv criteria for recurrent mdd and current hdrs score in the moderately-to-severely depressed range (greater than or equal to 18).
    Descripción

    Major Depressive Disorder Volunteer Sample | Mental Depression | Study Subject Right handed | Age | Major Depressive Disorder Primary | Recurrent major depressive episodes | Hamilton rating scale for depression | Moderate depression | Severe depression

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1269683
    UMLS CUI [1,2]
    C0150095
    UMLS CUI [2]
    C0011570
    UMLS CUI [3,1]
    C0681850
    UMLS CUI [3,2]
    C0344333
    UMLS CUI [4]
    C0001779
    UMLS CUI [5,1]
    C1269683
    UMLS CUI [5,2]
    C0205225
    UMLS CUI [6]
    C0154409
    UMLS CUI [7]
    C0451203
    UMLS CUI [8]
    C0588007
    UMLS CUI [9]
    C0588008
    mdd sample-remitted depressed (n = 15, phase 2): right-handed subjects (ages 18-50) will be selected with a past history of mdd by dsm-iv criteria.
    Descripción

    Major Depressive Disorder Volunteer Sample | Mental Depression Remitting | Study Subject Right handed | Age | Major Depressive Disorder

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1269683
    UMLS CUI [1,2]
    C0150095
    UMLS CUI [2,1]
    C0011570
    UMLS CUI [2,2]
    C0439600
    UMLS CUI [3,1]
    C0681850
    UMLS CUI [3,2]
    C0344333
    UMLS CUI [4]
    C0001779
    UMLS CUI [5]
    C1269683
    healthy relatives of mdd subjects (n=45)
    Descripción

    Major Depressive Disorder Study Subject Relative Healthy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1269683
    UMLS CUI [1,2]
    C0681850
    UMLS CUI [1,3]
    C0080103
    UMLS CUI [1,4]
    C3898900
    right-handed subjects (ages 18-55) will be selected who have a first-degree relative with mdd but do not themselves meet criteria for a psychiatric disorder. subjects will be matched to depressed and control subjects for age, gender, and education.
    Descripción

    Study Subject Right handed | Age | First Degree Relative Major Depressive Disorder | Mental disorders | Gender | Education

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0681850
    UMLS CUI [1,2]
    C0344333
    UMLS CUI [2]
    C0001779
    UMLS CUI [3,1]
    C1517194
    UMLS CUI [3,2]
    C1269683
    UMLS CUI [4]
    C0004936
    UMLS CUI [5]
    C0079399
    UMLS CUI [6]
    C0013622
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    subjects will be recruited who are drug-na ve or who have not received psychotropic drugs for at least 3 weeks (8 weeks for fluoxetine) prior to scanning. effective medications will not be discontinued for the purposes of the study. subjects will also be excluded if they have a) serious suicidal ideation or behavior, b) psychosis to the extent that the ability to provide informed consent is in doubt, c) medical conditions or concomitant medications (see appendix iii) that are likely to influence cerebral blood flow or neurological function including cardiovascular, respiratory, endocrine and neurological diseases, d) a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (dsm-iv criteria), e) current pregnancy (as documented by pregnancy testing prior to scanning), f) general mri exclusion criteria, g) history of non-response to zoloft or of intolerable or adverse side effects during zoloft treatment. additional exclusion criteria applied to control subjects are: a) subjects with a current or past history of other axis i psychiatric conditions, b) subjects with first-degree family members with current or past history of mood disorder.
    Descripción

    Pharmaceutical Preparations Therapy naive | Psychotropic Drugs | Fluoxetine | Feeling suicidal Serious | Suicidal behavior Serious | Psychotic Disorders Informed Consent Limited | Other medical condition Affecting Cerebral Blood Flow | Other medical condition Limited neurologic function | Pharmaceutical Preparations Affecting Cerebral Blood Flow | Pharmaceutical Preparations Limited neurologic function | Cardiovascular Diseases | Respiration Disorders | Endocrine System Diseases | nervous system disorder | Substance Use Disorders | Substance Dependence Lifetime | Pregnancy Pregnancy Test | Magnetic Resonance Imaging Exclusion Criteria General | Unresponsive to Treatment Zoloft | Adverse reaction to Zoloft | Axis I diagnosis | First Degree Relative Mood Disorders

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0919936
    UMLS CUI [2]
    C0033978
    UMLS CUI [3]
    C0016365
    UMLS CUI [4,1]
    C0424000
    UMLS CUI [4,2]
    C0205404
    UMLS CUI [5,1]
    C1760428
    UMLS CUI [5,2]
    C0205404
    UMLS CUI [6,1]
    C0033975
    UMLS CUI [6,2]
    C0021430
    UMLS CUI [6,3]
    C0439801
    UMLS CUI [7,1]
    C3843040
    UMLS CUI [7,2]
    C0392760
    UMLS CUI [7,3]
    C0428714
    UMLS CUI [8,1]
    C3843040
    UMLS CUI [8,2]
    C0497548
    UMLS CUI [9,1]
    C0013227
    UMLS CUI [9,2]
    C0392760
    UMLS CUI [9,3]
    C0428714
    UMLS CUI [10,1]
    C0013227
    UMLS CUI [10,2]
    C0497548
    UMLS CUI [11]
    C0007222
    UMLS CUI [12]
    C0035204
    UMLS CUI [13]
    C0014130
    UMLS CUI [14]
    C0027765
    UMLS CUI [15]
    C0038586
    UMLS CUI [16,1]
    C0038580
    UMLS CUI [16,2]
    C4071830
    UMLS CUI [17,1]
    C0032961
    UMLS CUI [17,2]
    C0032976
    UMLS CUI [18,1]
    C0024485
    UMLS CUI [18,2]
    C0680251
    UMLS CUI [18,3]
    C0205246
    UMLS CUI [19,1]
    C0205269
    UMLS CUI [19,2]
    C0284660
    UMLS CUI [20,1]
    C0041755
    UMLS CUI [20,2]
    C0284660
    UMLS CUI [21]
    C0270287
    UMLS CUI [22,1]
    C1517194
    UMLS CUI [22,2]
    C0525045
    subjects beyond age 55 are excluded to reduce the biological heterogeneity encompassed by the mdd criteria, and to reduce the variability of the bold signal. subjects whose first major depressive episodes arose temporally after other major medical or psychiatric conditions will also be excluded, since their functional imaging results generally differ from those reported in primary mdd.
    Descripción

    Age | Heterogeneity biological | Major Depressive Disorder criteria | BOLD Signal | Single major depressive episode | Other medical condition Major | Mental disorders Major | Major Depressive Disorder Primary

    Tipo de datos

    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 [4,1]
    C1655730
    UMLS CUI [4,2]
    C1710082
    UMLS CUI [5]
    C0024517
    UMLS CUI [6,1]
    C3843040
    UMLS CUI [6,2]
    C0205164
    UMLS CUI [7,1]
    C0004936
    UMLS CUI [7,2]
    C0205164
    UMLS CUI [8,1]
    C1269683
    UMLS CUI [8,2]
    C0205225

    Similar models

    Eligibility Current Major Depressive Disorder NCT00071123

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Healthy Volunteers
    Item
    healthy volunteers (n=65)
    boolean
    C1708335 (UMLS CUI [1])
    Control Group Healthy | Study Subject Right handed | Age | Mental disorders Major | First Degree Relative Mood Disorders | Hamilton rating scale for depression | Gender | Education
    Item
    healthy control sample (n = 30, phase 1; n = 15, phase 3; n=20, phase 5): right-handed subjects (ages 18-55) 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 (less than or equal to 7). control subjects will be matched to depressed subjects for age, gender, and education.
    boolean
    C0009932 (UMLS CUI [1,1])
    C3898900 (UMLS CUI [1,2])
    C0681850 (UMLS CUI [2,1])
    C0344333 (UMLS CUI [2,2])
    C0001779 (UMLS CUI [3])
    C0004936 (UMLS CUI [4,1])
    C0205164 (UMLS CUI [4,2])
    C1517194 (UMLS CUI [5,1])
    C0525045 (UMLS CUI [5,2])
    C0451203 (UMLS CUI [6])
    C0079399 (UMLS CUI [7])
    C0013622 (UMLS CUI [8])
    Major Depressive Disorder Volunteer Sample
    Item
    mdd samples (n =80)
    boolean
    C1269683 (UMLS CUI [1,1])
    C0150095 (UMLS CUI [1,2])
    Major Depressive Disorder Volunteer Sample | Mental Depression | Study Subject Right handed | Age | Major Depressive Disorder Primary | Recurrent major depressive episodes | Hamilton rating scale for depression | Moderate depression | Severe depression
    Item
    mdd sample-currently depressed (n = 30, phase 1; n = 15, phase 3; n=20, phase 5): right-handed subjects (ages 18-55) will be selected with primary mdd currently depressed by dsm-iv criteria for recurrent mdd and current hdrs score in the moderately-to-severely depressed range (greater than or equal to 18).
    boolean
    C1269683 (UMLS CUI [1,1])
    C0150095 (UMLS CUI [1,2])
    C0011570 (UMLS CUI [2])
    C0681850 (UMLS CUI [3,1])
    C0344333 (UMLS CUI [3,2])
    C0001779 (UMLS CUI [4])
    C1269683 (UMLS CUI [5,1])
    C0205225 (UMLS CUI [5,2])
    C0154409 (UMLS CUI [6])
    C0451203 (UMLS CUI [7])
    C0588007 (UMLS CUI [8])
    C0588008 (UMLS CUI [9])
    Major Depressive Disorder Volunteer Sample | Mental Depression Remitting | Study Subject Right handed | Age | Major Depressive Disorder
    Item
    mdd sample-remitted depressed (n = 15, phase 2): right-handed subjects (ages 18-50) will be selected with a past history of mdd by dsm-iv criteria.
    boolean
    C1269683 (UMLS CUI [1,1])
    C0150095 (UMLS CUI [1,2])
    C0011570 (UMLS CUI [2,1])
    C0439600 (UMLS CUI [2,2])
    C0681850 (UMLS CUI [3,1])
    C0344333 (UMLS CUI [3,2])
    C0001779 (UMLS CUI [4])
    C1269683 (UMLS CUI [5])
    Major Depressive Disorder Study Subject Relative Healthy
    Item
    healthy relatives of mdd subjects (n=45)
    boolean
    C1269683 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    C0080103 (UMLS CUI [1,3])
    C3898900 (UMLS CUI [1,4])
    Study Subject Right handed | Age | First Degree Relative Major Depressive Disorder | Mental disorders | Gender | Education
    Item
    right-handed subjects (ages 18-55) will be selected who have a first-degree relative with mdd but do not themselves meet criteria for a psychiatric disorder. subjects will be matched to depressed and control subjects for age, gender, and education.
    boolean
    C0681850 (UMLS CUI [1,1])
    C0344333 (UMLS CUI [1,2])
    C0001779 (UMLS CUI [2])
    C1517194 (UMLS CUI [3,1])
    C1269683 (UMLS CUI [3,2])
    C0004936 (UMLS CUI [4])
    C0079399 (UMLS CUI [5])
    C0013622 (UMLS CUI [6])
    Item Group
    C0680251 (UMLS CUI)
    Pharmaceutical Preparations Therapy naive | Psychotropic Drugs | Fluoxetine | Feeling suicidal Serious | Suicidal behavior Serious | Psychotic Disorders Informed Consent Limited | Other medical condition Affecting Cerebral Blood Flow | Other medical condition Limited neurologic function | Pharmaceutical Preparations Affecting Cerebral Blood Flow | Pharmaceutical Preparations Limited neurologic function | Cardiovascular Diseases | Respiration Disorders | Endocrine System Diseases | nervous system disorder | Substance Use Disorders | Substance Dependence Lifetime | Pregnancy Pregnancy Test | Magnetic Resonance Imaging Exclusion Criteria General | Unresponsive to Treatment Zoloft | Adverse reaction to Zoloft | Axis I diagnosis | First Degree Relative Mood Disorders
    Item
    subjects will be recruited who are drug-na ve or who have not received psychotropic drugs for at least 3 weeks (8 weeks for fluoxetine) prior to scanning. effective medications will not be discontinued for the purposes of the study. subjects will also be excluded if they have a) serious suicidal ideation or behavior, b) psychosis to the extent that the ability to provide informed consent is in doubt, c) medical conditions or concomitant medications (see appendix iii) that are likely to influence cerebral blood flow or neurological function including cardiovascular, respiratory, endocrine and neurological diseases, d) a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (dsm-iv criteria), e) current pregnancy (as documented by pregnancy testing prior to scanning), f) general mri exclusion criteria, g) history of non-response to zoloft or of intolerable or adverse side effects during zoloft treatment. additional exclusion criteria applied to control subjects are: a) subjects with a current or past history of other axis i psychiatric conditions, b) subjects with first-degree family members with current or past history of mood disorder.
    boolean
    C0013227 (UMLS CUI [1,1])
    C0919936 (UMLS CUI [1,2])
    C0033978 (UMLS CUI [2])
    C0016365 (UMLS CUI [3])
    C0424000 (UMLS CUI [4,1])
    C0205404 (UMLS CUI [4,2])
    C1760428 (UMLS CUI [5,1])
    C0205404 (UMLS CUI [5,2])
    C0033975 (UMLS CUI [6,1])
    C0021430 (UMLS CUI [6,2])
    C0439801 (UMLS CUI [6,3])
    C3843040 (UMLS CUI [7,1])
    C0392760 (UMLS CUI [7,2])
    C0428714 (UMLS CUI [7,3])
    C3843040 (UMLS CUI [8,1])
    C0497548 (UMLS CUI [8,2])
    C0013227 (UMLS CUI [9,1])
    C0392760 (UMLS CUI [9,2])
    C0428714 (UMLS CUI [9,3])
    C0013227 (UMLS CUI [10,1])
    C0497548 (UMLS CUI [10,2])
    C0007222 (UMLS CUI [11])
    C0035204 (UMLS CUI [12])
    C0014130 (UMLS CUI [13])
    C0027765 (UMLS CUI [14])
    C0038586 (UMLS CUI [15])
    C0038580 (UMLS CUI [16,1])
    C4071830 (UMLS CUI [16,2])
    C0032961 (UMLS CUI [17,1])
    C0032976 (UMLS CUI [17,2])
    C0024485 (UMLS CUI [18,1])
    C0680251 (UMLS CUI [18,2])
    C0205246 (UMLS CUI [18,3])
    C0205269 (UMLS CUI [19,1])
    C0284660 (UMLS CUI [19,2])
    C0041755 (UMLS CUI [20,1])
    C0284660 (UMLS CUI [20,2])
    C0270287 (UMLS CUI [21])
    C1517194 (UMLS CUI [22,1])
    C0525045 (UMLS CUI [22,2])
    Age | Heterogeneity biological | Major Depressive Disorder criteria | BOLD Signal | Single major depressive episode | Other medical condition Major | Mental disorders Major | Major Depressive Disorder Primary
    Item
    subjects beyond age 55 are excluded to reduce the biological heterogeneity encompassed by the mdd criteria, and to reduce the variability of the bold signal. subjects whose first major depressive episodes arose temporally after other major 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])
    C1655730 (UMLS CUI [4,1])
    C1710082 (UMLS CUI [4,2])
    C0024517 (UMLS CUI [5])
    C3843040 (UMLS CUI [6,1])
    C0205164 (UMLS CUI [6,2])
    C0004936 (UMLS CUI [7,1])
    C0205164 (UMLS CUI [7,2])
    C1269683 (UMLS CUI [8,1])
    C0205225 (UMLS CUI [8,2])

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