ID

17082

Beskrivning

Neurocardiac Control in Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00084162

Länk

https://clinicaltrials.gov/show/NCT00084162

Nyckelord

Versioner (1)
  1. 2016-08-24 2016-08-24 -
Uppladdad den

24 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depression, Involutional NCT00084162

Engelsk

Eligibility Depression, Involutional NCT00084162

1 Formulär  
Criteria
Beskrivning

Criteria

two groups of right-handed subjects, male or premenopausal female, who are drug-naive or who have not received psychotropic drugs for at least 3 weeks (8 weeks for fluoxetine), will be recruited for studies under this protocol: unipolar depressives and healthy controls individually matched to depressives by age, gender and smoking status. because effective treatment will not be discontinued for the purposes of this protocol, subjects in the patient groups will be identified who have never been treated for or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reason prior to study entry.
Beskrivning

Groups Study Subject Quantity Handedness | Gender | Premenopausal | Pharmaceutical Preparations Therapy naive | Psychotropic Drugs | Fluoxetine | Unipolar Depression | Healthy | Depressive disorder | Age | Smoking Status | Medication stopped Due to Lack of Efficacy | Medication stopped Due to Patient Non-Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0023114
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0279752
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0919936
UMLS CUI [5]
C0033978
UMLS CUI [6]
C0016365
UMLS CUI [7]
C0041696
UMLS CUI [8]
C3898900
UMLS CUI [9]
C0011581
UMLS CUI [10]
C0001779
UMLS CUI [11]
C1519386
UMLS CUI [12,1]
C1273478
UMLS CUI [12,2]
C0678226
UMLS CUI [12,3]
C0235828
UMLS CUI [13,1]
C1273478
UMLS CUI [13,2]
C0678226
UMLS CUI [13,3]
C0376405
the presence of inclusion and exclusion criteria will be established using both an unstructured clinical interview with a psychiatrist and the structure clinical interview for dsm-iv (scid). family history of mental illness will be obtained using the family interview of genetic studies.
Beskrivning

Clinical interview unstructured Psychiatrist | Structured Clinical Interview DSM-IV | family history of mental illness | Psychiatric interview of family of patient | Genetic studies

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0199182
UMLS CUI [1,2]
C0683960
UMLS CUI [1,3]
C0033872
UMLS CUI [2,1]
C0935589
UMLS CUI [2,2]
C0220952
UMLS CUI [3]
C2186268
UMLS CUI [4]
C0204499
UMLS CUI [5]
C2827447
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects will be excluded if they have:
Beskrivning

ID.3

Datatyp

boolean

serious suicidal ideation or behavior;
Beskrivning

Feeling suicidal Serious | Suicidal behavior Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1760428
UMLS CUI [2,2]
C0205404
inability to provide informed consent;
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
medical or neurological illnesses likely to affect physiology or anatomy;
Beskrivning

Illness Affecting physiology | Illness Affecting Anatomy | nervous system disorder Affecting physiology | nervous system disorder Affecting Anatomy

Datatyp

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
a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (dsm-iv criteria);
Beskrivning

Substance Use Disorders | Substance Dependence Lifetime

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C4071830
current or past history of other axis i disorders that preceded the onset of mdd;
Beskrivning

Axis I diagnosis Before Major Depressive Disorder Onset

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C1269683
UMLS CUI [1,4]
C0332162
current pregnancy (documented by pregnancy testing prior to scanning);
Beskrivning

Pregnancy Pregnancy Test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0032976
current breast feeding;
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
general mri exclusion criteria;
Beskrivning

Exclusion Criteria MRI General

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0205246
vision and/or hearing problems severe enough to interfere with testing.
Beskrivning

Visual Impairment Interferes with Testing | Hearing problem Interferes with Testing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3665347
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0039593
UMLS CUI [2,1]
C0260662
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0039593
exposure within two weeks to medications likely to affect cerebral blood glow or heart rate.
Beskrivning

Pharmaceutical Preparations Exposure Affecting Cerebral Blood Flow | Pharmaceutical Preparations Exposure Affecting heart rate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0428714
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0018810
any condition that may prevent the subject from performing the run/walk test, or
Beskrivning

Condition Preventing walk test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0430517
irregular menstrual cycles so that menstrual phase cannot be reliably determined, or
Beskrivning

Abnormal menstrual cycle | Menstrual cycle phase Determinate Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1]
C0232933
UMLS CUI [2,1]
C1818633
UMLS CUI [2,2]
C0205259
UMLS CUI [2,3]
C1272705
any ecg finding that would contraindicate pet scanning or run/walk testing (e.g. non-sinus rhythm, significant tachycardia, st segment elevation or depression, q waves) or arrhythmia that would obviate accurate calculation of hrv indices. cardiology consultation will be obtained for abnormal ecg findings unless it is unequivocally clear in the judgment of the study physician that such consultation is medically unnecessary.
Beskrivning

EKG finding Contraindication PET scan | EKG finding Contraindication Walk test | ecg non-sinus rhythm | Tachycardia Significant | ST segment elevation | ST segment depression | Electrocardiogram Q waves test | Cardiac Arrhythmia | ECG abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0032743
UMLS CUI [2,1]
C0438154
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C0430517
UMLS CUI [3]
C3649284
UMLS CUI [4,1]
C0039231
UMLS CUI [4,2]
C0750502
UMLS CUI [5]
C0520886
UMLS CUI [6]
C0520887
UMLS CUI [7]
C0429089
UMLS CUI [8]
C0003811
UMLS CUI [9]
C0522055
subjects who are beyond age 50 who are either postmenopausal or perimenopausal are excluded to reduce the biological heterogeneity in autonomic function which may be associated with difference in menstrual status.
Beskrivning

Age | Postmenopausal state | Perimenopausal state | Autonomic function Heterogeneity biological | Menstrual status Difference

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
UMLS CUI [3]
C3839366
UMLS CUI [4,1]
C0518003
UMLS CUI [4,2]
C0019409
UMLS CUI [4,3]
C0205460
UMLS CUI [5,1]
C0369663
UMLS CUI [5,2]
C1705242
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Similar models

Eligibility Depression, Involutional NCT00084162

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Groups Study Subject Quantity Handedness | Gender | Premenopausal | Pharmaceutical Preparations Therapy naive | Psychotropic Drugs | Fluoxetine | Unipolar Depression | Healthy | Depressive disorder | Age | Smoking Status | Medication stopped Due to Lack of Efficacy | Medication stopped Due to Patient Non-Compliance
Item
two groups of right-handed subjects, male or premenopausal female, who are drug-naive or who have not received psychotropic drugs for at least 3 weeks (8 weeks for fluoxetine), will be recruited for studies under this protocol: unipolar depressives and healthy controls individually matched to depressives by age, gender and smoking status. because effective treatment will not be discontinued for the purposes of this protocol, subjects in the patient groups will be identified who have never been treated for or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reason prior to study entry.
boolean
C0441833 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0023114 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2])
C0279752 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0919936 (UMLS CUI [4,2])
C0033978 (UMLS CUI [5])
C0016365 (UMLS CUI [6])
C0041696 (UMLS CUI [7])
C3898900 (UMLS CUI [8])
C0011581 (UMLS CUI [9])
C0001779 (UMLS CUI [10])
C1519386 (UMLS CUI [11])
C1273478 (UMLS CUI [12,1])
C0678226 (UMLS CUI [12,2])
C0235828 (UMLS CUI [12,3])
C1273478 (UMLS CUI [13,1])
C0678226 (UMLS CUI [13,2])
C0376405 (UMLS CUI [13,3])
Clinical interview unstructured Psychiatrist | Structured Clinical Interview DSM-IV | family history of mental illness | Psychiatric interview of family of patient | Genetic studies
Item
the presence of inclusion and exclusion criteria will be established using both an unstructured clinical interview with a psychiatrist and the structure clinical interview for dsm-iv (scid). family history of mental illness will be obtained using the family interview of genetic studies.
boolean
C0199182 (UMLS CUI [1,1])
C0683960 (UMLS CUI [1,2])
C0033872 (UMLS CUI [1,3])
C0935589 (UMLS CUI [2,1])
C0220952 (UMLS CUI [2,2])
C2186268 (UMLS CUI [3])
C0204499 (UMLS CUI [4])
C2827447 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
ID.3
Item
subjects will be excluded if they have:
boolean
Feeling suicidal Serious | Suicidal behavior Serious
Item
serious suicidal ideation or behavior;
boolean
C0424000 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1760428 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Informed Consent Unable
Item
inability to provide informed consent;
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Illness Affecting physiology | Illness Affecting Anatomy | nervous system disorder Affecting physiology | nervous system disorder Affecting Anatomy
Item
medical or neurological illnesses likely to affect physiology or anatomy;
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])
Substance Use Disorders | Substance Dependence Lifetime
Item
a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (dsm-iv criteria);
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
Axis I diagnosis Before Major Depressive Disorder Onset
Item
current or past history of other axis i disorders that preceded the onset of mdd;
boolean
C0270287 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1269683 (UMLS CUI [1,3])
C0332162 (UMLS CUI [1,4])
Pregnancy Pregnancy Test
Item
current pregnancy (documented by pregnancy testing prior to scanning);
boolean
C0032961 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Breast Feeding
Item
current breast feeding;
boolean
C0006147 (UMLS CUI [1])
Exclusion Criteria MRI General
Item
general mri exclusion criteria;
boolean
C0680251 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
Visual Impairment Interferes with Testing | Hearing problem Interferes with Testing
Item
vision and/or hearing problems severe enough to interfere with testing.
boolean
C3665347 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0260662 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0039593 (UMLS CUI [2,3])
Pharmaceutical Preparations Exposure Affecting Cerebral Blood Flow | Pharmaceutical Preparations Exposure Affecting heart rate
Item
exposure within two weeks to medications likely to affect cerebral blood glow or heart rate.
boolean
C0013227 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0428714 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0018810 (UMLS CUI [2,4])
Condition Preventing walk test
Item
any condition that may prevent the subject from performing the run/walk test, or
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0430517 (UMLS CUI [1,3])
Abnormal menstrual cycle | Menstrual cycle phase Determinate Unsuccessful
Item
irregular menstrual cycles so that menstrual phase cannot be reliably determined, or
boolean
C0232933 (UMLS CUI [1])
C1818633 (UMLS CUI [2,1])
C0205259 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
EKG finding Contraindication PET scan | EKG finding Contraindication Walk test | ecg non-sinus rhythm | Tachycardia Significant | ST segment elevation | ST segment depression | Electrocardiogram Q waves test | Cardiac Arrhythmia | ECG abnormal
Item
any ecg finding that would contraindicate pet scanning or run/walk testing (e.g. non-sinus rhythm, significant tachycardia, st segment elevation or depression, q waves) or arrhythmia that would obviate accurate calculation of hrv indices. cardiology consultation will be obtained for abnormal ecg findings unless it is unequivocally clear in the judgment of the study physician that such consultation is medically unnecessary.
boolean
C0438154 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C0438154 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0430517 (UMLS CUI [2,3])
C3649284 (UMLS CUI [3])
C0039231 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0520886 (UMLS CUI [5])
C0520887 (UMLS CUI [6])
C0429089 (UMLS CUI [7])
C0003811 (UMLS CUI [8])
C0522055 (UMLS CUI [9])
Age | Postmenopausal state | Perimenopausal state | Autonomic function Heterogeneity biological | Menstrual status Difference
Item
subjects who are beyond age 50 who are either postmenopausal or perimenopausal are excluded to reduce the biological heterogeneity in autonomic function which may be associated with difference in menstrual status.
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C3839366 (UMLS CUI [3])
C0518003 (UMLS CUI [4,1])
C0019409 (UMLS CUI [4,2])
C0205460 (UMLS CUI [4,3])
C0369663 (UMLS CUI [5,1])
C1705242 (UMLS CUI [5,2])
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