ID

16983

Description

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

Link

https://clinicaltrials.gov/show/NCT00071123

Keywords

Versions (2)
  1. 8/17/16 8/17/16 -
  2. 8/17/16 8/17/16 -
Uploaded on

August 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Current Major Depressive Disorder NCT00071123

English

Eligibility Current Major Depressive Disorder NCT00071123

1 forms  
Criteria
Description

Criteria

healthy volunteers (n=65)
Description

Healthy Volunteers

Data type

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.
Description

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

Data type

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)
Description

Major Depressive Disorder Volunteer Sample

Data type

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).
Description

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

Data type

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.
Description

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

Data type

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)
Description

Major Depressive Disorder Study Subject Relative Healthy

Data type

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.
Description

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

Data type

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
Description

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.
Description

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

Data type

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.
Description

Age | Heterogeneity biological | Major Depressive Disorder criteria | BOLD Signal | Single major depressive episode | Other medical condition Major | Mental disorders Major | 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 [4,1]
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
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Similar models

Eligibility Current Major Depressive Disorder NCT00071123

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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