ID

30505

Beschreibung

Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00787501

Link

https://clinicaltrials.gov/show/NCT00787501

Stichworte

Versionen (1)
  1. 10.06.18 10.06.18 -
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See clinicaltrials.gov

Hochgeladen am

10. Juni 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00787501

Englisch

Eligibility Major Depressive Disorder NCT00787501

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. meet dsm-iv criteria for major depressive disorder (one or more lifetime episodes, separated by at least two months of a return to normal functioning, in a current episode).
Beschreibung

Major Depressive Disorder | Depressive episode Lifetime Quantity | Depressive episode

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2,1]
C0349217
UMLS CUI [2,2]
C4071830
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0349217
2. male or female outpatients between the ages of 18 and 55 at time of enrollment.
Beschreibung

Outpatients | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
3. females only must be surgically sterile, post-menopausal for at least one year, or not pregnant and using a method of birth control that is acceptable to the investigator.
Beschreibung

Female Sterilization | Postmenopausal state | Pregnancy Absent | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
4. have a total score of 14 or more on the first 17-items of the hrsd at both the initial and secondary interviews.
Beschreibung

Hamilton Depression Rating Scale 17 Item Clinical Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C3639712
5. be in reasonably good health. patients with hypothyroidism, diabetes, high blood pressure, chronic respiratory, or other medical conditions may be considered candidates for study enrollment at the discretion of the investigator if their conditions are stable, they have been receiving standard therapies for the treatment of the condition, the prescribed dose and regiment of medication has been stable for at least 3 months, and all appropriate clinical and lab parameters are within normal limits for the condition that are clinically acceptable to the investigator
Beschreibung

Good health Acceptable | Hypothyroidism | Diabetes Mellitus | Hypertensive disease | Chronic disease of respiratory system | Other medical condition | Standard of Care Received | Pharmaceutical Preparations Dosage Stable | Laboratory Results Within Normal limits

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3813622
UMLS CUI [1,2]
C1879533
UMLS CUI [2]
C0020676
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0020538
UMLS CUI [5]
C0264220
UMLS CUI [6]
C3843040
UMLS CUI [7,1]
C2936643
UMLS CUI [7,2]
C1514756
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C0178602
UMLS CUI [8,3]
C0205360
UMLS CUI [9,1]
C1254595
UMLS CUI [9,2]
C0442816
6. be free of prescription psychotropic medications for two weeks (four weeks for fluoxetine) before study entry.
Beschreibung

Psychotropic Drugs Prescription Free of | Fluoxetine Free of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0033080
UMLS CUI [1,3]
C0332296
UMLS CUI [2,1]
C0016365
UMLS CUI [2,2]
C0332296
7. provide written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. being unable to complete questionnaires written in english, representing an active suicide risk (see below), active alcohol or drug dependence, having any eye problems or difficulties in corrected vision, having a north american adult reading test (naart) equivalent fsiq < 85.
Beschreibung

Questionnaires English Language Completion Unable | At risk for suicide | Substance Dependence | Eye problem | Corrected visual acuity Difficulty | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C1299582
UMLS CUI [2]
C0563664
UMLS CUI [3]
C0038580
UMLS CUI [4]
C0262477
UMLS CUI [5,1]
C1275680
UMLS CUI [5,2]
C0332218
UMLS CUI [6]
C3846158
2. pregnant women and those planning to become pregnant during the first 11 months after intake will also be excluded from the study. pregnancy will be determined by self-report at the interview and by a pregnancy test at the time of the mri scan. there will be no cost to the participant for the pregnancy test.
Beschreibung

Pregnancy | Pregnancy, Planned | Gender Pregnancy Test | MRI Scan

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0032976
UMLS CUI [4]
C0917711
3. people who have metallic foreign objects in their body, such as aneurysm clips or pacemakers, as well as individuals prone to panicking in enclosed spaces will be excluded from the study. subjects with a questionable history of metallic fragments will also be excluded.
Beschreibung

Foreign objects Metallic Body | Aneurysm clip | Artificial cardiac pacemaker | Claustrophobia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016542
UMLS CUI [1,2]
C2986473
UMLS CUI [1,3]
C1268086
UMLS CUI [2]
C0179977
UMLS CUI [3]
C0030163
UMLS CUI [4]
C0008909
4. participants who are taking psychotropic medications, particularly antidepressant medications within two weeks of study entry (4 weeks for fluoxetine) will be excluded.
Beschreibung

Psychotropic Drugs | Antidepressive Agents | Fluoxetine

Datentyp

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0016365
5. participants will not be excluded on the basis of herbs, supplements, and other prescription or over the counter drugs other than those noted. hiv serostatus will not be evaluated for the research study.
Beschreibung

Exception Herbs | Exception Supplement | Exception Pharmaceutical Preparations Other | Exception Non-Prescription Drugs Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0019240
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2348609
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0205394
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0013231
UMLS CUI [4,3]
C0205394
6. at the initial screening visit, if girth seems to present a potential issue for the mri, than width of participant will be assessed using a hula-hoop that is approximately the same diameter as the mr scanner. if subject exceeds the width of the hula-hoop, then they will be excluded from the study.
Beschreibung

Problem Measurement of girth Relationship Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033213
UMLS CUI [1,2]
C0203911
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0024485
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Ähnliche Modelle

Eligibility Major Depressive Disorder NCT00787501

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder | Depressive episode Lifetime Quantity | Depressive episode
Item
1. meet dsm-iv criteria for major depressive disorder (one or more lifetime episodes, separated by at least two months of a return to normal functioning, in a current episode).
boolean
C1269683 (UMLS CUI [1])
C0349217 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0349217 (UMLS CUI [3])
Outpatients | Age
Item
2. male or female outpatients between the ages of 18 and 55 at time of enrollment.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Female Sterilization | Postmenopausal state | Pregnancy Absent | Gender Contraceptive methods
Item
3. females only must be surgically sterile, post-menopausal for at least one year, or not pregnant and using a method of birth control that is acceptable to the investigator.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
4. have a total score of 14 or more on the first 17-items of the hrsd at both the initial and secondary interviews.
boolean
C3639712 (UMLS CUI [1])
Good health Acceptable | Hypothyroidism | Diabetes Mellitus | Hypertensive disease | Chronic disease of respiratory system | Other medical condition | Standard of Care Received | Pharmaceutical Preparations Dosage Stable | Laboratory Results Within Normal limits
Item
5. be in reasonably good health. patients with hypothyroidism, diabetes, high blood pressure, chronic respiratory, or other medical conditions may be considered candidates for study enrollment at the discretion of the investigator if their conditions are stable, they have been receiving standard therapies for the treatment of the condition, the prescribed dose and regiment of medication has been stable for at least 3 months, and all appropriate clinical and lab parameters are within normal limits for the condition that are clinically acceptable to the investigator
boolean
C3813622 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0020676 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
C0264220 (UMLS CUI [5])
C3843040 (UMLS CUI [6])
C2936643 (UMLS CUI [7,1])
C1514756 (UMLS CUI [7,2])
C0013227 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0205360 (UMLS CUI [8,3])
C1254595 (UMLS CUI [9,1])
C0442816 (UMLS CUI [9,2])
Psychotropic Drugs Prescription Free of | Fluoxetine Free of
Item
6. be free of prescription psychotropic medications for two weeks (four weeks for fluoxetine) before study entry.
boolean
C0033978 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0016365 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
Informed Consent
Item
7. provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Questionnaires English Language Completion Unable | At risk for suicide | Substance Dependence | Eye problem | Corrected visual acuity Difficulty | Other Coding
Item
1. being unable to complete questionnaires written in english, representing an active suicide risk (see below), active alcohol or drug dependence, having any eye problems or difficulties in corrected vision, having a north american adult reading test (naart) equivalent fsiq < 85.
boolean
C0034394 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0563664 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
C0262477 (UMLS CUI [4])
C1275680 (UMLS CUI [5,1])
C0332218 (UMLS CUI [5,2])
C3846158 (UMLS CUI [6])
Pregnancy | Pregnancy, Planned | Gender Pregnancy Test | MRI Scan
Item
2. pregnant women and those planning to become pregnant during the first 11 months after intake will also be excluded from the study. pregnancy will be determined by self-report at the interview and by a pregnancy test at the time of the mri scan. there will be no cost to the participant for the pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C0917711 (UMLS CUI [4])
Foreign objects Metallic Body | Aneurysm clip | Artificial cardiac pacemaker | Claustrophobia
Item
3. people who have metallic foreign objects in their body, such as aneurysm clips or pacemakers, as well as individuals prone to panicking in enclosed spaces will be excluded from the study. subjects with a questionable history of metallic fragments will also be excluded.
boolean
C0016542 (UMLS CUI [1,1])
C2986473 (UMLS CUI [1,2])
C1268086 (UMLS CUI [1,3])
C0179977 (UMLS CUI [2])
C0030163 (UMLS CUI [3])
C0008909 (UMLS CUI [4])
Psychotropic Drugs | Antidepressive Agents | Fluoxetine
Item
4. participants who are taking psychotropic medications, particularly antidepressant medications within two weeks of study entry (4 weeks for fluoxetine) will be excluded.
boolean
C0033978 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0016365 (UMLS CUI [3])
Exception Herbs | Exception Supplement | Exception Pharmaceutical Preparations Other | Exception Non-Prescription Drugs Other
Item
5. participants will not be excluded on the basis of herbs, supplements, and other prescription or over the counter drugs other than those noted. hiv serostatus will not be evaluated for the research study.
boolean
C1705847 (UMLS CUI [1,1])
C0019240 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2348609 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0013231 (UMLS CUI [4,2])
C0205394 (UMLS CUI [4,3])
Problem Measurement of girth Relationship Magnetic Resonance Imaging
Item
6. at the initial screening visit, if girth seems to present a potential issue for the mri, than width of participant will be assessed using a hula-hoop that is approximately the same diameter as the mr scanner. if subject exceeds the width of the hula-hoop, then they will be excluded from the study.
boolean
C0033213 (UMLS CUI [1,1])
C0203911 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
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