ID

18055

Description

FMRI Study of Performance During a Probabilistic Reversal Learning Task in Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00075296

Link

https://clinicaltrials.gov/show/NCT00075296

Keywords

  1. 10/17/16 10/17/16 -
Uploaded on

October 17, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT00075296

Eligibility Major Depressive Disorder NCT00075296

Criteria
Description

Criteria

all subjects will be between 18 and 50 years old. male and female subjects will be included. all subjects must be able to give written informed consent prior to participation in this study.
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
mdd depressed sample: twenty five subjects (ages 18-50) male and female will be selected, with primary mdd currently depressed as defined by dsm-iv criteria for recurrent mdd, in a current major depressive episode and who have a first degree relative with mdd but no first degree relatives with mania, alcoholism, or antisocial personality disorder.
Description

Volunteer sample | Age | Major Depressive Disorder Primary | Feeling depressed | Major Depressive Disorder Recurrent | major depressive episode | First Degree Relative | Major Depressive Disorder | Manic | Alcoholic Intoxication, Chronic | Antisocial Personality Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0150095
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C1269683
UMLS CUI [3,2]
C0205225
UMLS CUI [4]
C0497307
UMLS CUI [5,1]
C1269683
UMLS CUI [5,2]
C2945760
UMLS CUI [6]
C0024517
UMLS CUI [7]
C1517194
UMLS CUI [8]
C1269683
UMLS CUI [9]
C0338831
UMLS CUI [10]
C0001973
UMLS CUI [11]
C0003431
mdd remission sample: twenty subjects (ages 18-50) male and female will be selected. remission is defined as a period of at least three months during which the subject has not taken an antidepressant agent, with hamilton depression rating scale (hdrs; 21-item; hamilton 1960) scores in the non-depressed range (less than 8), and with no more than one clinically significant depressive symptom.
Description

Volunteer sample | Age | Major depression in remission | Antidepressive Agents | Hamilton rating scale for depression | Depressive Symptom Clinical Significance Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0150095
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0270461
UMLS CUI [4]
C0003289
UMLS CUI [5]
C0451203
UMLS CUI [6,1]
C0086132
UMLS CUI [6,2]
C2826293
UMLS CUI [6,3]
C1265611
bipolar depressed sample: twenty five subjects (ages 18-50) male and female will be selected who meet dsm-iv criteria for bipolar i or ii disorder and are currently in a depressed phase.
Description

Volunteer sample | Age | Bipolar I disorder | Bipolar II disorder | Feeling depressed

Data type

boolean

Alias
UMLS CUI [1]
C0150095
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0853193
UMLS CUI [4]
C0236788
UMLS CUI [5]
C0497307
healthy control sample: thirty subjects (ages 18-50) male and female who have not met criteria for any major psychiatric disorder will be selected. from this large sample a control subject will be matched to each depressed subject for age, gender, handedness and iq. the control subjects will have no known first degree relatives with mood disorders.
Description

Healthy Volunteers Control Group | Age | Mental disorders Major | Gender | Handedness | Intelligence quotient | First Degree Relative | Mood Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0009932
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205164
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0023114
UMLS CUI [6]
C0456149
UMLS CUI [7]
C1517194
UMLS CUI [8]
C0525045
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
individuals with any major medical or neurological disorder or who have received psychotropic drugs or medication likely to influence cerebral blood flow or metabolism within 3 weeks (8 weeks for fluoxetine [prozac]), of scanning.
Description

Disease Major | nervous system disorder Major | Psychotropic Drugs | Pharmaceutical Preparations Affecting Cerebral Blood Flow | Pharmaceutical Preparations Affecting Metabolism | Fluoxetine | Prozac

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205164
UMLS CUI [3]
C0033978
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0428714
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0025519
UMLS CUI [6]
C0016365
UMLS CUI [7]
C0162373
bipolar subjects with rapid cycling or with current psychosis will be excluded from the protocol.
Description

Rapid cycling bipolar I disorder | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C2063820
UMLS CUI [2]
C0033975
effective treatment will not be discontinued for the purposes of this protocol, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reasons prior to study entry.
Description

Patients untreated | Pharmaceutical Preparations Discontinued Due to Lack of Efficacy | Pharmaceutical Preparations Discontinued Due to Non-Compliance | Pharmaceutical Preparations Discontinued Due to Physician order | Pharmaceutical Preparations Discontinued Due to Other reasons

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0235828
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0376405
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C1444662
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C1546491
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C1444662
UMLS CUI [5,3]
C0678226
UMLS CUI [5,4]
C3845511
individuals who meet dsm-iv criteria for alcohol and/or substance abuse within 1 year prior to screening or lifetime history of substance dependence.
Description

Substance Use Disorders | Substance Dependence Lifetime

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C4071830
women of childbearing potential who are known to be pregnant or who have a positive pregnancy test.
Description

Childbearing Potential Pregnancy | Childbearing Potential Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0240802
individuals who have experienced serious suicidal ideation within the past 2 months.
Description

Feeling suicidal Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0205404
general exclusions for mri imaging, such as having had a cardiac pacemaker or ferromagnetic object implanted through surgical intervention or accident (for example: shrapnel).
Description

Exclusion General Magnetic Resonance Imaging | Artificial cardiac pacemaker | Implantation Metallic foreign body

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0205246
UMLS CUI [1,3]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3,1]
C0021107
UMLS CUI [3,2]
C1720389

Similar models

Eligibility Major Depressive Disorder NCT00075296

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age | Informed Consent
Item
all subjects will be between 18 and 50 years old. male and female subjects will be included. all subjects must be able to give written informed consent prior to participation in this study.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Volunteer sample | Age | Major Depressive Disorder Primary | Feeling depressed | Major Depressive Disorder Recurrent | major depressive episode | First Degree Relative | Major Depressive Disorder | Manic | Alcoholic Intoxication, Chronic | Antisocial Personality Disorder
Item
mdd depressed sample: twenty five subjects (ages 18-50) male and female will be selected, with primary mdd currently depressed as defined by dsm-iv criteria for recurrent mdd, in a current major depressive episode and who have a first degree relative with mdd but no first degree relatives with mania, alcoholism, or antisocial personality disorder.
boolean
C0150095 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1269683 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
C0497307 (UMLS CUI [4])
C1269683 (UMLS CUI [5,1])
C2945760 (UMLS CUI [5,2])
C0024517 (UMLS CUI [6])
C1517194 (UMLS CUI [7])
C1269683 (UMLS CUI [8])
C0338831 (UMLS CUI [9])
C0001973 (UMLS CUI [10])
C0003431 (UMLS CUI [11])
Volunteer sample | Age | Major depression in remission | Antidepressive Agents | Hamilton rating scale for depression | Depressive Symptom Clinical Significance Quantity
Item
mdd remission sample: twenty subjects (ages 18-50) male and female will be selected. remission is defined as a period of at least three months during which the subject has not taken an antidepressant agent, with hamilton depression rating scale (hdrs; 21-item; hamilton 1960) scores in the non-depressed range (less than 8), and with no more than one clinically significant depressive symptom.
boolean
C0150095 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0270461 (UMLS CUI [3])
C0003289 (UMLS CUI [4])
C0451203 (UMLS CUI [5])
C0086132 (UMLS CUI [6,1])
C2826293 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
Volunteer sample | Age | Bipolar I disorder | Bipolar II disorder | Feeling depressed
Item
bipolar depressed sample: twenty five subjects (ages 18-50) male and female will be selected who meet dsm-iv criteria for bipolar i or ii disorder and are currently in a depressed phase.
boolean
C0150095 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0853193 (UMLS CUI [3])
C0236788 (UMLS CUI [4])
C0497307 (UMLS CUI [5])
Healthy Volunteers Control Group | Age | Mental disorders Major | Gender | Handedness | Intelligence quotient | First Degree Relative | Mood Disorders
Item
healthy control sample: thirty subjects (ages 18-50) male and female who have not met criteria for any major psychiatric disorder will be selected. from this large sample a control subject will be matched to each depressed subject for age, gender, handedness and iq. the control subjects will have no known first degree relatives with mood disorders.
boolean
C1708335 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0004936 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4])
C0023114 (UMLS CUI [5])
C0456149 (UMLS CUI [6])
C1517194 (UMLS CUI [7])
C0525045 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Disease Major | nervous system disorder Major | Psychotropic Drugs | Pharmaceutical Preparations Affecting Cerebral Blood Flow | Pharmaceutical Preparations Affecting Metabolism | Fluoxetine | Prozac
Item
individuals with any major medical or neurological disorder or who have received psychotropic drugs or medication likely to influence cerebral blood flow or metabolism within 3 weeks (8 weeks for fluoxetine [prozac]), of scanning.
boolean
C0012634 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0033978 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0428714 (UMLS CUI [4,3])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0025519 (UMLS CUI [5,3])
C0016365 (UMLS CUI [6])
C0162373 (UMLS CUI [7])
Rapid cycling bipolar I disorder | Psychotic Disorders
Item
bipolar subjects with rapid cycling or with current psychosis will be excluded from the protocol.
boolean
C2063820 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
Patients untreated | Pharmaceutical Preparations Discontinued Due to Lack of Efficacy | Pharmaceutical Preparations Discontinued Due to Non-Compliance | Pharmaceutical Preparations Discontinued Due to Physician order | Pharmaceutical Preparations Discontinued Due to Other reasons
Item
effective treatment will not be discontinued for the purposes of this protocol, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reasons prior to study entry.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0235828 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0376405 (UMLS CUI [3,4])
C0013227 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C1546491 (UMLS CUI [4,4])
C0013227 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0678226 (UMLS CUI [5,3])
C3845511 (UMLS CUI [5,4])
Substance Use Disorders | Substance Dependence Lifetime
Item
individuals who meet dsm-iv criteria for alcohol and/or substance abuse within 1 year prior to screening or lifetime history of substance dependence.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
Childbearing Potential Pregnancy | Childbearing Potential Pregnancy test positive
Item
women of childbearing potential who are known to be pregnant or who have a positive pregnancy test.
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0240802 (UMLS CUI [2,2])
Feeling suicidal Serious
Item
individuals who have experienced serious suicidal ideation within the past 2 months.
boolean
C0424000 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Exclusion General Magnetic Resonance Imaging | Artificial cardiac pacemaker | Implantation Metallic foreign body
Item
general exclusions for mri imaging, such as having had a cardiac pacemaker or ferromagnetic object implanted through surgical intervention or accident (for example: shrapnel).
boolean
C2828389 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0030163 (UMLS CUI [2])
C0021107 (UMLS CUI [3,1])
C1720389 (UMLS CUI [3,2])

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