ID

30528

Description

PET Biomarkers in Treatment Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01031810

Link

https://clinicaltrials.gov/show/NCT01031810

Keywords

  1. 6/11/18 6/11/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 11, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT01031810

Eligibility Major Depressive Disorder NCT01031810

Criteria
Description

Criteria

1. primary diagnosis of major depressive disorder
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
2. subjects aged 18-65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. depressed subjects must have treatment-resistant depression (trd) two previous adequate antidepressant treatment trial failures within the current depressive episode from different classes
Description

Depressive Disorder, Treatment-Resistant | Depressive episode | Antidepressant therapy Quantity failed | Antidepressive Agents Class Different

Data type

boolean

Alias
UMLS CUI [1]
C2063866
UMLS CUI [2]
C0349217
UMLS CUI [3,1]
C1096649
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0231175
UMLS CUI [4,1]
C0003289
UMLS CUI [4,2]
C0456387
UMLS CUI [4,3]
C1705242
4. minimum baseline montgomery asberg depression rating scale (madrs) score of 22
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
5. signs informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
6. subjects must be willing to be have a pet scan
Description

PET scan Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0600109
7. subjects must be antidepressant medication free for 3 weeks prior to pet scan
Description

Antidepressive Agents Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0332296
exclusion
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
1. significant past or present neurological disorder, including seizures, stroke, or head trauma
Description

Nervous system disorder | Seizures | Cerebrovascular accident | Craniocerebral Trauma

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0018674
2. history of bipolar disorder, psychosis, schizoaffective disorder, or schizophrenia
Description

Bipolar Disorder | Psychotic Disorders | Schizoaffective Disorder | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0036337
UMLS CUI [4]
C0036341
3. moderate or high level of suicide risk, as determined by a score of 3 or 4 on item 3 of the ham-d scale. also excluded will be those who present a significant suicide risk by history or current psychiatrist's assessment.
Description

Moderate suicide risk Hamilton rating scale for depression | High suicide risk Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1,1]
C1271075
UMLS CUI [1,2]
C0451203
UMLS CUI [2,1]
C1271074
UMLS CUI [2,2]
C0451203
4. personality disorder which might interfere with compliance or increase suicide risk
Description

Personality Disorder Interferes with Compliance | Personality Disorders At risk for suicide Increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0031212
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1321605
UMLS CUI [2,1]
C0031212
UMLS CUI [2,2]
C0563664
UMLS CUI [2,3]
C0205217
5. alcohol or drug abuse or dependence in the past year; history of lifetime iv drug use or use of methylene diamine methamphetamine (mdma or "ecstasy") more than twice
Description

Substance Use Disorders | Substance Dependence | Intravenous drug use Lifetime | Using MDMA Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3,1]
C0699778
UMLS CUI [3,2]
C4071830
UMLS CUI [4,1]
C2188865
UMLS CUI [4,2]
C1265611
6. current thyroid dysfunction (past or currently treated dysfunction is acceptable)
Description

Thyroid dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0348024
7. clinically significant or unstable medical conditions or laboratory abnormalities, including hypertension (repeated bp > 140 systolic, > 90 diastolic)
Description

Medical condition Clinical Significance | Medical condition Unstable | Laboratory test result abnormal | Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0438215
UMLS CUI [4]
C0020538
UMLS CUI [5]
C0871470
UMLS CUI [6]
C0428883
8. intake of investigational (unapproved) drug in the past 3 months
Description

Investigational New Drugs Non-Prescription

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0013231
9. electroconvulsive therapy (ect) in three months prior to screening
Description

Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
10. use of vagal nerve stimulation (vns)
Description

Vagus Nerve Stimulation

Data type

boolean

Alias
UMLS CUI [1]
C2350432
11. positive drug of abuse screen
Description

Drug abuse Screen positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0013146
UMLS CUI [1,2]
C0743295
12. anticoagulant treatment which cannot be discontinued for 10 days prior to pet scanning
Description

Anticoagulation Therapy Discontinuation Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1272705
13. pregnancy, currently lactating; planning to conceive during the course of study participation or abortion in the past two months.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Abortion

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0156543
14. dementia (clinical and neurocognitive criteria)
Description

Dementia | Criteria neurocognitive

Data type

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C0518895
15. claustrophobia of a severity which would not permit the participant to undergo an mri or a pet scan
Description

Claustrophobia Severe | MRI Excluded | PET scan Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C0332196
UMLS CUI [3,1]
C0032743
UMLS CUI [3,2]
C0332196
16. recent (< 7 days) consumption of ayahuasca tea or other south american non-standard decoction.
Description

Ayahuasca tea

Data type

boolean

Alias
UMLS CUI [1,1]
C0937833
UMLS CUI [1,2]
C0039400
17. presence of metallic devices, implants and other contraindications to scanning
Description

Presence of metallic device / implant | Medical contraindication Scanning

Data type

boolean

Alias
UMLS CUI [1]
C3693688
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0441633
18. current, past or anticipated exposure to radiation, that may include being badged for radiation exposure in the workplace or participation in nuclear medicine research protocols
Description

Exposure to Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1522449
19. smokers (use of tobacco products in the previous 3 months)
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
20. potential participants having taken an antidepressant medication in the last 3 weeks. participants otherwise eligible may elect to discontinue medication which has not been significantly helpful according to their report, their current psychiatrist's report (if available), and the evaluating psychiatrist. no patient will be asked to discontinue an effective antidepressant medication to participate.
Description

Antidepressive Agents | Antidepressive Agents ineffective To be stopped

Data type

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C3242229
UMLS CUI [2,3]
C1272691
21. history of previous mao-i treatment
Description

Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0026457

Similar models

Eligibility Major Depressive Disorder NCT01031810

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Major Depressive Disorder
Item
1. primary diagnosis of major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Age
Item
2. subjects aged 18-65
boolean
C0001779 (UMLS CUI [1])
Depressive Disorder, Treatment-Resistant | Depressive episode | Antidepressant therapy Quantity failed | Antidepressive Agents Class Different
Item
3. depressed subjects must have treatment-resistant depression (trd) two previous adequate antidepressant treatment trial failures within the current depressive episode from different classes
boolean
C2063866 (UMLS CUI [1])
C0349217 (UMLS CUI [2])
C1096649 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
C0003289 (UMLS CUI [4,1])
C0456387 (UMLS CUI [4,2])
C1705242 (UMLS CUI [4,3])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
4. minimum baseline montgomery asberg depression rating scale (madrs) score of 22
boolean
C4054475 (UMLS CUI [1])
Informed Consent
Item
5. signs informed consent form
boolean
C0021430 (UMLS CUI [1])
PET scan Willing
Item
6. subjects must be willing to be have a pet scan
boolean
C0032743 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Antidepressive Agents Free of
Item
7. subjects must be antidepressant medication free for 3 weeks prior to pet scan
boolean
C0003289 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
Exclusion Criteria
Item
exclusion
boolean
C0680251 (UMLS CUI [1])
Nervous system disorder | Seizures | Cerebrovascular accident | Craniocerebral Trauma
Item
1. significant past or present neurological disorder, including seizures, stroke, or head trauma
boolean
C0027765 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0018674 (UMLS CUI [4])
Bipolar Disorder | Psychotic Disorders | Schizoaffective Disorder | Schizophrenia
Item
2. history of bipolar disorder, psychosis, schizoaffective disorder, or schizophrenia
boolean
C0005586 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C0036341 (UMLS CUI [4])
Moderate suicide risk Hamilton rating scale for depression | High suicide risk Hamilton rating scale for depression
Item
3. moderate or high level of suicide risk, as determined by a score of 3 or 4 on item 3 of the ham-d scale. also excluded will be those who present a significant suicide risk by history or current psychiatrist's assessment.
boolean
C1271075 (UMLS CUI [1,1])
C0451203 (UMLS CUI [1,2])
C1271074 (UMLS CUI [2,1])
C0451203 (UMLS CUI [2,2])
Personality Disorder Interferes with Compliance | Personality Disorders At risk for suicide Increased
Item
4. personality disorder which might interfere with compliance or increase suicide risk
boolean
C0031212 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0031212 (UMLS CUI [2,1])
C0563664 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
Substance Use Disorders | Substance Dependence | Intravenous drug use Lifetime | Using MDMA Quantity
Item
5. alcohol or drug abuse or dependence in the past year; history of lifetime iv drug use or use of methylene diamine methamphetamine (mdma or "ecstasy") more than twice
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0699778 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
C2188865 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Thyroid dysfunction
Item
6. current thyroid dysfunction (past or currently treated dysfunction is acceptable)
boolean
C0348024 (UMLS CUI [1])
Medical condition Clinical Significance | Medical condition Unstable | Laboratory test result abnormal | Hypertensive disease | Systolic Pressure | Diastolic blood pressure
Item
7. clinically significant or unstable medical conditions or laboratory abnormalities, including hypertension (repeated bp > 140 systolic, > 90 diastolic)
boolean
C3843040 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0438215 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
C0871470 (UMLS CUI [5])
C0428883 (UMLS CUI [6])
Investigational New Drugs Non-Prescription
Item
8. intake of investigational (unapproved) drug in the past 3 months
boolean
C0013230 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
Electroconvulsive Therapy
Item
9. electroconvulsive therapy (ect) in three months prior to screening
boolean
C0013806 (UMLS CUI [1])
Vagus Nerve Stimulation
Item
10. use of vagal nerve stimulation (vns)
boolean
C2350432 (UMLS CUI [1])
Drug abuse Screen positive
Item
11. positive drug of abuse screen
boolean
C0013146 (UMLS CUI [1,1])
C0743295 (UMLS CUI [1,2])
Anticoagulation Therapy Discontinuation Unsuccessful
Item
12. anticoagulant treatment which cannot be discontinued for 10 days prior to pet scanning
boolean
C0003281 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Abortion
Item
13. pregnancy, currently lactating; planning to conceive during the course of study participation or abortion in the past two months.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0156543 (UMLS CUI [4])
Dementia | Criteria neurocognitive
Item
14. dementia (clinical and neurocognitive criteria)
boolean
C0497327 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C0518895 (UMLS CUI [2,2])
Claustrophobia Severe | MRI Excluded | PET scan Excluded
Item
15. claustrophobia of a severity which would not permit the participant to undergo an mri or a pet scan
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0032743 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Ayahuasca tea
Item
16. recent (< 7 days) consumption of ayahuasca tea or other south american non-standard decoction.
boolean
C0937833 (UMLS CUI [1,1])
C0039400 (UMLS CUI [1,2])
Presence of metallic device / implant | Medical contraindication Scanning
Item
17. presence of metallic devices, implants and other contraindications to scanning
boolean
C3693688 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0441633 (UMLS CUI [2,2])
Exposure to Therapeutic radiology procedure
Item
18. current, past or anticipated exposure to radiation, that may include being badged for radiation exposure in the workplace or participation in nuclear medicine research protocols
boolean
C0332157 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Tobacco use
Item
19. smokers (use of tobacco products in the previous 3 months)
boolean
C0543414 (UMLS CUI [1])
Antidepressive Agents | Antidepressive Agents ineffective To be stopped
Item
20. potential participants having taken an antidepressant medication in the last 3 weeks. participants otherwise eligible may elect to discontinue medication which has not been significantly helpful according to their report, their current psychiatrist's report (if available), and the evaluating psychiatrist. no patient will be asked to discontinue an effective antidepressant medication to participate.
boolean
C0003289 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C3242229 (UMLS CUI [2,2])
C1272691 (UMLS CUI [2,3])
Monoamine Oxidase Inhibitors
Item
21. history of previous mao-i treatment
boolean
C0026457 (UMLS CUI [1])

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