ID

21799

Descrizione

Antidepressant Effects on cAMP Specific Phosphodiesterase (PDE4) in Depressed Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00369798

collegamento

https://clinicaltrials.gov/show/NCT00369798

Keywords

versioni (1)
  1. 02/05/17 02/05/17 -
Caricato su

2 maggio 2017

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00369798

Inglese

Eligibility Major Depressive Disorder NCT00369798

1 moduli  
Criteria
Descrizione

Criteria

healthy volunteers (n = 70)
Descrizione

Healthy Volunteers

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1708335
healthy control sample (n = 70): sixty of these volunteers will have brain pet scans and 10 of these have only blood sampling to compare (r)-[(11)c]rolipram levels in artery and vein. healthy 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) (williams 1988) in the not depressed range (less than or equal to 7). control subjects will be matched to depressed subjects for age and gender. forty of these subjects will have (r)-[(11)c]rolipram pet scans with blood sampling and 10 subjects have only blood sampling without pet scan. the healthy volunteers who are used to measure the difference in (r)-[(11)c]rolipram concentration between the artery and the vein will not undergo psychiatric assessment because the data will not be compared with those of patients.
Descrizione

Control Group Healthy | complete positron emission tomography of brain | Collection of blood specimen for laboratory procedure | Rolipram Level Arteries | Rolipram Level Veins | Age | Mental disorder Major Absent | Mood Disorder First Degree Relative Absent | Hamilton Depression Rating Scale 17 Item Questionnaire | Gender

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C3898900
UMLS CUI [2]
C2094592
UMLS CUI [3]
C0005834
UMLS CUI [4,1]
C0073561
UMLS CUI [4,2]
C0441889
UMLS CUI [4,3]
C0003842
UMLS CUI [5,1]
C0073561
UMLS CUI [5,2]
C0441889
UMLS CUI [5,3]
C0042449
UMLS CUI [6]
C0001779
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0205164
UMLS CUI [7,3]
C0332197
UMLS CUI [8,1]
C0525045
UMLS CUI [8,2]
C1517194
UMLS CUI [8,3]
C0332197
UMLS CUI [9]
C3639712
UMLS CUI [10]
C0079399
mdd samples (n = 65)
Descrizione

Major Depressive Disorder Sample

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0150095
mdd sample-currently depressed (n = 65): patients (ages 18-55) will be selected with primary mdd currently depressed by dsm-iv criteria for recurrent mdd and current 17-item hdrs score greater than or equal to 18 or montgomery-asberg depression rating scale (madrs) (noble et al 1991) greater than or equal to 20 indicating the moderately-to-severely depressed symptoms. all subjects must be physically healthy and aged 18 55 years.
Descrizione

Major Depressive Disorder Volunteer Sample | Feeling depressed | Age | Major Depressive Disorder Primary | Major Depressive Disorder Recurrent | Hamilton Depression Rating Scale 17 Item Questionnaire | Montgomery-Asberg Depression Rating Scale Questionnaire | Symptom moderate depressed | Symptom severe depressed | Healthy Volunteers

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0150095
UMLS CUI [2]
C0497307
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C1269683
UMLS CUI [4,2]
C0205225
UMLS CUI [5,1]
C1269683
UMLS CUI [5,2]
C2945760
UMLS CUI [6]
C3639712
UMLS CUI [7]
C4054475
UMLS CUI [8,1]
C0436344
UMLS CUI [8,2]
C0497307
UMLS CUI [9,1]
C0436345
UMLS CUI [9,2]
C0497307
UMLS CUI [10]
C1708335
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects will be recruited who are drug-na(sqrroot) ve or who have not received psychotropic drugs for at least 2 weeks (6 weeks for fluoxetine) prior to scanning. effective medications will not be discontinued for the purposes of the study.
Descrizione

Study Subject Pharmaceutical Preparations naive | Psychotropic Drugs | Fluoxetine | Pharmaceutical Preparations Effective Continued

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0919936
UMLS CUI [2]
C0033978
UMLS CUI [3]
C0016365
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C1280519
UMLS CUI [4,3]
C0549178
subjects will also be excluded if they have:
Descrizione

Study Subject Excluded

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C2828389
1. serious suicidal ideation or behavior
Descrizione

Feeling suicidal | Suicidal behavior

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C1760428
2. psychosis
Descrizione

Psychotic Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0033975
3. medical conditions or concomitant medications that are likely to influence pet measurement or have significant interactions with sertraline, citalopram or escitalopram.
Descrizione

Medical condition Affecting Positron-Emission Tomography | Pharmaceutical Preparations Affecting Positron-Emission Tomography | Medical condition Interaction Sertraline | Medical condition Interaction Citalopram | Medical condition Interaction Escitalopram | Pharmaceutical Preparations Interaction Sertraline | Pharmaceutical Preparations Interaction Citalopram | Pharmaceutical Preparations Interaction Escitalopram

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0032743
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0032743
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0687133
UMLS CUI [3,3]
C0074393
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0687133
UMLS CUI [4,3]
C0008845
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0687133
UMLS CUI [5,3]
C1099456
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0687133
UMLS CUI [6,3]
C0074393
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C0687133
UMLS CUI [7,3]
C0008845
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C0687133
UMLS CUI [8,3]
C1099456
4. a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (dsm-iv criteria)
Descrizione

Substance Use Disorders | Substance Dependence Lifetime

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C4071830
5. positive urine drug screen
Descrizione

Urine drug screen positive

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0743300
6. current pregnancy (as documented by pregnancy testing prior to scanning)
Descrizione

Pregnancy Pregnancy Test

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0032976
7. general mri exclusion criteria
Descrizione

Exclusion Criteria MRI General

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0205246
8. major depression that arose following another major medical or psychiatric condition, and
Descrizione

Major Depressive Disorder following Medical condition Major | Major Depressive Disorder following Mental disorder Major

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C3843040
UMLS CUI [1,4]
C0205164
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0231290
UMLS CUI [2,3]
C0004936
UMLS CUI [2,4]
C0205164
9. prior participation in other research protocols within a year such that radiation exposure would exceed the annual guidelines
Descrizione

Study Subject Participation Status | Exposure to radiation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0015333
for patients who have two [c-11]rolipram pet scans, one before and another after ssri treatment, previous failures of or intolerance to ssri may not allow for treatment in the current protocol. in clinical practice, medication can be switched between sertraline and citalopram/escitalopram because sertraline and citalopram/escitalopram have somewhat different therapeutic effects and adverse reactions. along these lines, we will consider citalopram and its enantiomer escitalopram as being equivalent to each other. patients will therefore be excluded from the study with two [c-11]rolipram pet scans if they previously failed to respond to adequate treatment trials of all medications available for use in the study, or if they have a history of being unable to tolerate all of the study medications. specifically, patients will be excluded from the study with two [c-11]rolipram pet scans if they:
Descrizione

Rolipram | Positron-Emission Tomography Quantity | Selective Serotonin Reuptake Inhibitors | Selective Serotonin Reuptake Inhibitors failed | Intolerance to Selective Serotonin Reuptake Inhibitors | Sertraline | Citalopram | Escitalopram | Pharmaceutical Preparations Absent response to treatment | Intolerance to Investigational New Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0073561
UMLS CUI [2,1]
C0032743
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0360105
UMLS CUI [4,1]
C0360105
UMLS CUI [4,2]
C0231175
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0360105
UMLS CUI [6]
C0074393
UMLS CUI [7]
C0008845
UMLS CUI [8]
C1099456
UMLS CUI [9,1]
C0013227
UMLS CUI [9,2]
C0438286
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C0013230
j) previously proved unresponsive to therapeutic trials of both sertraline and citalopram/escitalopram.
Descrizione

Sertraline | Citalopram | Escitalopram | Absent response to treatment

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0074393
UMLS CUI [2]
C0008845
UMLS CUI [3]
C1099456
UMLS CUI [4]
C0438286
k) previously developed allergic reactions to both sertraline and citalopram/escitalopram, or discontinued both sertraline and citalopram/escitalopram due to an adverse effect
Descrizione

Allergic Reaction Sertraline | Allergic Reaction Citalopram | Allergic Reaction Escitalopram | Sertraline Discontinued Due to Adverse effect | Citalopram Discontinued Due to Adverse effect | Escitalopram Discontinued Due to Adverse effect

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0074393
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0008845
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1099456
UMLS CUI [4,1]
C0074393
UMLS CUI [4,2]
C1444662
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0879626
UMLS CUI [5,1]
C0008845
UMLS CUI [5,2]
C1444662
UMLS CUI [5,3]
C0678226
UMLS CUI [5,4]
C0879626
UMLS CUI [6,1]
C1099456
UMLS CUI [6,2]
C1444662
UMLS CUI [6,3]
C0678226
UMLS CUI [6,4]
C0879626
l) through any combination of therapeutic unresponsiveness and adverse medication effects, are unsuitable for treatment with both sertraline and citalopram/escitalopram
Descrizione

Absent response to treatment | Adverse effects Pharmaceutical Preparations | Sertraline Inappropriate | Citalopram Inappropriate | Escitalopram Inappropriate

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0438286
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C0013227
UMLS CUI [3,1]
C0074393
UMLS CUI [3,2]
C1548788
UMLS CUI [4,1]
C0008845
UMLS CUI [4,2]
C1548788
UMLS CUI [5,1]
C1099456
UMLS CUI [5,2]
C1548788
m) prolonged qtc in ecg
Descrizione

Prolonged QTc interval on ECG

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4015677
please note that the exclusion criteria j, k, and l do not apply to patients who have one [c-11]rolipram pet without having antidepressant treatment in this protocol.
Descrizione

Rolipram | Positron-Emission Tomography | Antidepressant therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0073561
UMLS CUI [2]
C0032743
UMLS CUI [3]
C1096649
additional exclusion criteria applied to control subjects are:
Descrizione

Exclusion Criteria Control Group

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0009932
n) subjects with a current or past history of other axis i psychiatric conditions
Descrizione

Axis I diagnosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0270287
o) subjects with first-degree family members with current or past history of mood disorder.
Descrizione

Mood Disorder First Degree Relative

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0525045
UMLS CUI [1,2]
C1517194
please note that these exclusion criteria (with the exception of f and i) do not apply to the healthy volunteers who are used to measure the difference in (r)-[(11)c]rolipram concentration between the artery and the vein, without pet scanning.
Descrizione

Healthy Volunteers | Rolipram Concentration measurement Arteries | Rolipram Concentration measurement Veins | Positron-Emission Tomography

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0073561
UMLS CUI [2,2]
C1446561
UMLS CUI [2,3]
C0003842
UMLS CUI [3,1]
C0073561
UMLS CUI [3,2]
C1446561
UMLS CUI [3,3]
C0042449
UMLS CUI [4]
C0032743
subjects beyond age 55 are excluded to reduce the biological heterogeneity encompassed by the mdd criteria, and to reduce the variability of pet data.
Descrizione

Age | Heterogeneity biological Reduction | Variability PET Data Reduction

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0019409
UMLS CUI [2,2]
C0205460
UMLS CUI [2,3]
C0392756
UMLS CUI [3,1]
C2827666
UMLS CUI [3,2]
C0032743
UMLS CUI [3,3]
C1511726
UMLS CUI [3,4]
C0392756
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Similar models

Eligibility Major Depressive Disorder NCT00369798

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Healthy Volunteers
Item
healthy volunteers (n = 70)
boolean
C1708335 (UMLS CUI [1])
Control Group Healthy | complete positron emission tomography of brain | Collection of blood specimen for laboratory procedure | Rolipram Level Arteries | Rolipram Level Veins | Age | Mental disorder Major Absent | Mood Disorder First Degree Relative Absent | Hamilton Depression Rating Scale 17 Item Questionnaire | Gender
Item
healthy control sample (n = 70): sixty of these volunteers will have brain pet scans and 10 of these have only blood sampling to compare (r)-[(11)c]rolipram levels in artery and vein. healthy 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) (williams 1988) in the not depressed range (less than or equal to 7). control subjects will be matched to depressed subjects for age and gender. forty of these subjects will have (r)-[(11)c]rolipram pet scans with blood sampling and 10 subjects have only blood sampling without pet scan. the healthy volunteers who are used to measure the difference in (r)-[(11)c]rolipram concentration between the artery and the vein will not undergo psychiatric assessment because the data will not be compared with those of patients.
boolean
C0009932 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C2094592 (UMLS CUI [2])
C0005834 (UMLS CUI [3])
C0073561 (UMLS CUI [4,1])
C0441889 (UMLS CUI [4,2])
C0003842 (UMLS CUI [4,3])
C0073561 (UMLS CUI [5,1])
C0441889 (UMLS CUI [5,2])
C0042449 (UMLS CUI [5,3])
C0001779 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0205164 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
C0525045 (UMLS CUI [8,1])
C1517194 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
C3639712 (UMLS CUI [9])
C0079399 (UMLS CUI [10])
Major Depressive Disorder Sample
Item
mdd samples (n = 65)
boolean
C1269683 (UMLS CUI [1,1])
C0150095 (UMLS CUI [1,2])
Major Depressive Disorder Volunteer Sample | Feeling depressed | Age | Major Depressive Disorder Primary | Major Depressive Disorder Recurrent | Hamilton Depression Rating Scale 17 Item Questionnaire | Montgomery-Asberg Depression Rating Scale Questionnaire | Symptom moderate depressed | Symptom severe depressed | Healthy Volunteers
Item
mdd sample-currently depressed (n = 65): patients (ages 18-55) will be selected with primary mdd currently depressed by dsm-iv criteria for recurrent mdd and current 17-item hdrs score greater than or equal to 18 or montgomery-asberg depression rating scale (madrs) (noble et al 1991) greater than or equal to 20 indicating the moderately-to-severely depressed symptoms. all subjects must be physically healthy and aged 18 55 years.
boolean
C1269683 (UMLS CUI [1,1])
C0150095 (UMLS CUI [1,2])
C0497307 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1269683 (UMLS CUI [4,1])
C0205225 (UMLS CUI [4,2])
C1269683 (UMLS CUI [5,1])
C2945760 (UMLS CUI [5,2])
C3639712 (UMLS CUI [6])
C4054475 (UMLS CUI [7])
C0436344 (UMLS CUI [8,1])
C0497307 (UMLS CUI [8,2])
C0436345 (UMLS CUI [9,1])
C0497307 (UMLS CUI [9,2])
C1708335 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Study Subject Pharmaceutical Preparations naive | Psychotropic Drugs | Fluoxetine | Pharmaceutical Preparations Effective Continued
Item
subjects will be recruited who are drug-na(sqrroot) ve or who have not received psychotropic drugs for at least 2 weeks (6 weeks for fluoxetine) prior to scanning. effective medications will not be discontinued for the purposes of the study.
boolean
C0681850 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,3])
C0033978 (UMLS CUI [2])
C0016365 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C1280519 (UMLS CUI [4,2])
C0549178 (UMLS CUI [4,3])
Study Subject Excluded
Item
subjects will also be excluded if they have:
boolean
C0681850 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Feeling suicidal | Suicidal behavior
Item
1. serious suicidal ideation or behavior
boolean
C0424000 (UMLS CUI [1])
C1760428 (UMLS CUI [2])
Psychotic Disorders
Item
2. psychosis
boolean
C0033975 (UMLS CUI [1])
Medical condition Affecting Positron-Emission Tomography | Pharmaceutical Preparations Affecting Positron-Emission Tomography | Medical condition Interaction Sertraline | Medical condition Interaction Citalopram | Medical condition Interaction Escitalopram | Pharmaceutical Preparations Interaction Sertraline | Pharmaceutical Preparations Interaction Citalopram | Pharmaceutical Preparations Interaction Escitalopram
Item
3. medical conditions or concomitant medications that are likely to influence pet measurement or have significant interactions with sertraline, citalopram or escitalopram.
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0687133 (UMLS CUI [3,2])
C0074393 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0687133 (UMLS CUI [4,2])
C0008845 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0687133 (UMLS CUI [5,2])
C1099456 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C0687133 (UMLS CUI [6,2])
C0074393 (UMLS CUI [6,3])
C0013227 (UMLS CUI [7,1])
C0687133 (UMLS CUI [7,2])
C0008845 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C0687133 (UMLS CUI [8,2])
C1099456 (UMLS CUI [8,3])
Substance Use Disorders | Substance Dependence Lifetime
Item
4. 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])
Urine drug screen positive
Item
5. positive urine drug screen
boolean
C0743300 (UMLS CUI [1])
Pregnancy Pregnancy Test
Item
6. current pregnancy (as documented by pregnancy testing prior to scanning)
boolean
C0032961 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Exclusion Criteria MRI General
Item
7. general mri exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
Major Depressive Disorder following Medical condition Major | Major Depressive Disorder following Mental disorder Major
Item
8. major depression that arose following another major medical or psychiatric condition, and
boolean
C1269683 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C1269683 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
C0004936 (UMLS CUI [2,3])
C0205164 (UMLS CUI [2,4])
Study Subject Participation Status | Exposure to radiation
Item
9. prior participation in other research protocols within a year such that radiation exposure would exceed the annual guidelines
boolean
C2348568 (UMLS CUI [1])
C0015333 (UMLS CUI [2])
Rolipram | Positron-Emission Tomography Quantity | Selective Serotonin Reuptake Inhibitors | Selective Serotonin Reuptake Inhibitors failed | Intolerance to Selective Serotonin Reuptake Inhibitors | Sertraline | Citalopram | Escitalopram | Pharmaceutical Preparations Absent response to treatment | Intolerance to Investigational New Drugs
Item
for patients who have two [c-11]rolipram pet scans, one before and another after ssri treatment, previous failures of or intolerance to ssri may not allow for treatment in the current protocol. in clinical practice, medication can be switched between sertraline and citalopram/escitalopram because sertraline and citalopram/escitalopram have somewhat different therapeutic effects and adverse reactions. along these lines, we will consider citalopram and its enantiomer escitalopram as being equivalent to each other. patients will therefore be excluded from the study with two [c-11]rolipram pet scans if they previously failed to respond to adequate treatment trials of all medications available for use in the study, or if they have a history of being unable to tolerate all of the study medications. specifically, patients will be excluded from the study with two [c-11]rolipram pet scans if they:
boolean
C0073561 (UMLS CUI [1])
C0032743 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0360105 (UMLS CUI [3])
C0360105 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0360105 (UMLS CUI [5,2])
C0074393 (UMLS CUI [6])
C0008845 (UMLS CUI [7])
C1099456 (UMLS CUI [8])
C0013227 (UMLS CUI [9,1])
C0438286 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C0013230 (UMLS CUI [10,2])
Sertraline | Citalopram | Escitalopram | Absent response to treatment
Item
j) previously proved unresponsive to therapeutic trials of both sertraline and citalopram/escitalopram.
boolean
C0074393 (UMLS CUI [1])
C0008845 (UMLS CUI [2])
C1099456 (UMLS CUI [3])
C0438286 (UMLS CUI [4])
Allergic Reaction Sertraline | Allergic Reaction Citalopram | Allergic Reaction Escitalopram | Sertraline Discontinued Due to Adverse effect | Citalopram Discontinued Due to Adverse effect | Escitalopram Discontinued Due to Adverse effect
Item
k) previously developed allergic reactions to both sertraline and citalopram/escitalopram, or discontinued both sertraline and citalopram/escitalopram due to an adverse effect
boolean
C1527304 (UMLS CUI [1,1])
C0074393 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0008845 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C1099456 (UMLS CUI [3,2])
C0074393 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0879626 (UMLS CUI [4,4])
C0008845 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0678226 (UMLS CUI [5,3])
C0879626 (UMLS CUI [5,4])
C1099456 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0678226 (UMLS CUI [6,3])
C0879626 (UMLS CUI [6,4])
Absent response to treatment | Adverse effects Pharmaceutical Preparations | Sertraline Inappropriate | Citalopram Inappropriate | Escitalopram Inappropriate
Item
l) through any combination of therapeutic unresponsiveness and adverse medication effects, are unsuitable for treatment with both sertraline and citalopram/escitalopram
boolean
C0438286 (UMLS CUI [1])
C0879626 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0074393 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0008845 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1099456 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
Prolonged QTc interval on ECG
Item
m) prolonged qtc in ecg
boolean
C4015677 (UMLS CUI [1])
Rolipram | Positron-Emission Tomography | Antidepressant therapy
Item
please note that the exclusion criteria j, k, and l do not apply to patients who have one [c-11]rolipram pet without having antidepressant treatment in this protocol.
boolean
C0073561 (UMLS CUI [1])
C0032743 (UMLS CUI [2])
C1096649 (UMLS CUI [3])
Exclusion Criteria Control Group
Item
additional exclusion criteria applied to control subjects are:
boolean
C0680251 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Axis I diagnosis
Item
n) subjects with a current or past history of other axis i psychiatric conditions
boolean
C0270287 (UMLS CUI [1])
Mood Disorder First Degree Relative
Item
o) subjects with first-degree family members with current or past history of mood disorder.
boolean
C0525045 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
Healthy Volunteers | Rolipram Concentration measurement Arteries | Rolipram Concentration measurement Veins | Positron-Emission Tomography
Item
please note that these exclusion criteria (with the exception of f and i) do not apply to the healthy volunteers who are used to measure the difference in (r)-[(11)c]rolipram concentration between the artery and the vein, without pet scanning.
boolean
C1708335 (UMLS CUI [1])
C0073561 (UMLS CUI [2,1])
C1446561 (UMLS CUI [2,2])
C0003842 (UMLS CUI [2,3])
C0073561 (UMLS CUI [3,1])
C1446561 (UMLS CUI [3,2])
C0042449 (UMLS CUI [3,3])
C0032743 (UMLS CUI [4])
Age | Heterogeneity biological Reduction | Variability PET Data Reduction
Item
subjects beyond age 55 are excluded to reduce the biological heterogeneity encompassed by the mdd criteria, and to reduce the variability of pet data.
boolean
C0001779 (UMLS CUI [1])
C0019409 (UMLS CUI [2,1])
C0205460 (UMLS CUI [2,2])
C0392756 (UMLS CUI [2,3])
C2827666 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
C1511726 (UMLS CUI [3,3])
C0392756 (UMLS CUI [3,4])
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