ID

30519

Beskrivning

rTMS for Adolescents and Young Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00984087

Länk

https://clinicaltrials.gov/show/NCT00984087

Nyckelord

Versioner (1)
  1. 2018-06-11 2018-06-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00984087

Engelsk

Eligibility Major Depressive Disorder NCT00984087

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with mdd by a child and adolescent psychiatrist based on the dsm-iv, have a cdrs score of at least 60 or an hdrs score of at least 22 and have been suffering with depression during the current episode for at least 3 months
Beskrivning

Major Depressive Disorder | Depression in children Rating scale | Hamilton depression rating scale (HDRS) | Depressive episode Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2,1]
C3826462
UMLS CUI [2,2]
C0681889
UMLS CUI [3]
C2021166
UMLS CUI [4,1]
C0349217
UMLS CUI [4,2]
C0449238
currently seeing a johns hopkins psychiatrist
Beskrivning

Patient Visit Psychiatrist

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0033872
excellent documentation of treatment resistance:
Beskrivning

Unresponsive to Treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0205269
to at least 2 different antidepressant treatments, defined as resistance to a minimum of two antidepressant drug trials of adequate dose and duration in the current episode or previous episodes, adequacy being defined as a minimum level of three on the athf per antidepressant drug trial (those who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to three or more antidepressant medications in the current or a previous episode)
Beskrivning

Unresponsive to Antidepressant therapy Quantity | Antidepressive Agents Dose | Depressive episode | Intolerance to Antidepressive Agents Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C1096649
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0178602
UMLS CUI [3]
C0349217
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0003289
UMLS CUI [4,3]
C1265611
to at least one course of psychotherapy which did not result in significant alleviation of depressive symptoms
Beskrivning

Unresponsive to Psychotherapy Course Quantity | Depressive Symptoms Relief Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C0033968
UMLS CUI [1,3]
C0750729
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0086132
UMLS CUI [2,2]
C0564405
UMLS CUI [2,3]
C0332197
no changes in medication dose or psychotherapy frequency over the previous 1 month
Beskrivning

Medication dose unchanged | Psychotherapy Frequency unchanged

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0442739
UMLS CUI [2,1]
C0033968
UMLS CUI [2,2]
C0439603
UMLS CUI [2,3]
C0442739
negative answers on the safety screening questionnaire for rtms
Beskrivning

Answer Negative | Safety Questionnaire rTMS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1706817
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C0036043
UMLS CUI [2,2]
C0034394
UMLS CUI [2,3]
C0872259
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of substance abuse or dependence within the past six months (excluding nicotine and caffeine) or marked conduct disordered or oppositional behavior
Beskrivning

Substance Use Disorders | Substance Dependence | Exception Nicotine abuse | Exception Nicotine Dependence | Exception Caffeine abuse | Exception Caffeine dependence | Conduct Disorder Marked | Oppositional behavior

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2363943
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0028043
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1404070
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1386553
UMLS CUI [7,1]
C0149654
UMLS CUI [7,2]
C1706089
UMLS CUI [8]
C2013199
any current unstable medical or surgical illness
Beskrivning

Illness Unstable | Illness Surgical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0038895
bipolar disorder
Beskrivning

Bipolar Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0005586
psychotic symptoms
Beskrivning

Psychotic symptom

Datatyp

boolean

Alias
UMLS CUI [1]
C0871189
history of head injury or seizure or history of seizure in a first degree relative.
Beskrivning

Craniocerebral Trauma | Seizure | Seizure First Degree Relative

Datatyp

boolean

Alias
UMLS CUI [1]
C0018674
UMLS CUI [2]
C0036572
UMLS CUI [3,1]
C0036572
UMLS CUI [3,2]
C1517194
history of any metal in the head (outside the mouth).
Beskrivning

Metal foreign body in head Outside Mouth

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0561024
UMLS CUI [1,2]
C0205101
UMLS CUI [1,3]
C0230028
known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps
Beskrivning

Particles Metallic Eye | Pacemaker, Cardiac, Implantable | Lines Intracardiac | Implantable Neurostimulators | Surgical Clips | Pump

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0597177
UMLS CUI [1,2]
C2986473
UMLS CUI [1,3]
C0015392
UMLS CUI [2]
C0182148
UMLS CUI [3,1]
C0700221
UMLS CUI [3,2]
C0729936
UMLS CUI [4]
C2048402
UMLS CUI [5]
C0038917
UMLS CUI [6]
C0182537
history of frequent or severe headaches or migraines
Beskrivning

Frequent or severe headaches | Migraines Frequent | Migraines Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C3842524
UMLS CUI [2,1]
C0149931
UMLS CUI [2,2]
C0332183
UMLS CUI [3,1]
C0149931
UMLS CUI [3,2]
C0205082
history of hearing loss or known history of cochlear implants.
Beskrivning

Hearing Loss | Cochlear Implants

Datatyp

boolean

Alias
UMLS CUI [1]
C3887873
UMLS CUI [2]
C0009199
pregnancy or not using a reliable method of birth control.
Beskrivning

Pregnancy | Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332197
participation in another clinical trial within 30 days of this study
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
inability to locate and quantify a motor threshold (mt) as defined by the rtms protocol
Beskrivning

Motor Threshold Determination Unable | Motor Threshold Quantification Unable | rTMS Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0501384
UMLS CUI [1,2]
C0449864
UMLS CUI [1,3]
C1148554
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0501384
UMLS CUI [2,2]
C0449864
UMLS CUI [2,3]
C1709793
UMLS CUI [2,4]
C1299582
UMLS CUI [3,1]
C0872259
UMLS CUI [3,2]
C2348563
current use of drugs known to lower seizure threshold, such as stimulants, wellbutrin, bupropion, and certain tricyclics (e.g. clomipramine and maprotiline)
Beskrivning

Pharmaceutical Preparations Causing Lowered convulsive threshold | Stimulant | Wellbutrin | Bupropion | Tricyclic Antidepressive Agents | Clomipramine | Maprotiline

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0234976
UMLS CUI [2]
C0304402
UMLS CUI [3]
C0085934
UMLS CUI [4]
C0085208
UMLS CUI [5]
C0003290
UMLS CUI [6]
C0009010
UMLS CUI [7]
C0024778
left-handed
Beskrivning

Handedness

Datatyp

boolean

Alias
UMLS CUI [1]
C0023114
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Similar models

Eligibility Major Depressive Disorder NCT00984087

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder | Depression in children Rating scale | Hamilton depression rating scale (HDRS) | Depressive episode Duration
Item
diagnosed with mdd by a child and adolescent psychiatrist based on the dsm-iv, have a cdrs score of at least 60 or an hdrs score of at least 22 and have been suffering with depression during the current episode for at least 3 months
boolean
C1269683 (UMLS CUI [1])
C3826462 (UMLS CUI [2,1])
C0681889 (UMLS CUI [2,2])
C2021166 (UMLS CUI [3])
C0349217 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
Patient Visit Psychiatrist
Item
currently seeing a johns hopkins psychiatrist
boolean
C1512346 (UMLS CUI [1,1])
C0033872 (UMLS CUI [1,2])
Unresponsive to Treatment
Item
excellent documentation of treatment resistance:
boolean
C0205269 (UMLS CUI [1])
Unresponsive to Antidepressant therapy Quantity | Antidepressive Agents Dose | Depressive episode | Intolerance to Antidepressive Agents Quantity
Item
to at least 2 different antidepressant treatments, defined as resistance to a minimum of two antidepressant drug trials of adequate dose and duration in the current episode or previous episodes, adequacy being defined as a minimum level of three on the athf per antidepressant drug trial (those who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to three or more antidepressant medications in the current or a previous episode)
boolean
C0205269 (UMLS CUI [1,1])
C1096649 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0349217 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0003289 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Unresponsive to Psychotherapy Course Quantity | Depressive Symptoms Relief Absent
Item
to at least one course of psychotherapy which did not result in significant alleviation of depressive symptoms
boolean
C0205269 (UMLS CUI [1,1])
C0033968 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0086132 (UMLS CUI [2,1])
C0564405 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Medication dose unchanged | Psychotherapy Frequency unchanged
Item
no changes in medication dose or psychotherapy frequency over the previous 1 month
boolean
C3174092 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C0033968 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
C0442739 (UMLS CUI [2,3])
Answer Negative | Safety Questionnaire rTMS
Item
negative answers on the safety screening questionnaire for rtms
boolean
C1706817 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0036043 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0872259 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders | Substance Dependence | Exception Nicotine abuse | Exception Nicotine Dependence | Exception Caffeine abuse | Exception Caffeine dependence | Conduct Disorder Marked | Oppositional behavior
Item
history of substance abuse or dependence within the past six months (excluding nicotine and caffeine) or marked conduct disordered or oppositional behavior
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C2363943 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0028043 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1404070 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1386553 (UMLS CUI [6,2])
C0149654 (UMLS CUI [7,1])
C1706089 (UMLS CUI [7,2])
C2013199 (UMLS CUI [8])
Illness Unstable | Illness Surgical
Item
any current unstable medical or surgical illness
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0038895 (UMLS CUI [2,2])
Bipolar Disorder
Item
bipolar disorder
boolean
C0005586 (UMLS CUI [1])
Psychotic symptom
Item
psychotic symptoms
boolean
C0871189 (UMLS CUI [1])
Craniocerebral Trauma | Seizure | Seizure First Degree Relative
Item
history of head injury or seizure or history of seizure in a first degree relative.
boolean
C0018674 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0036572 (UMLS CUI [3,1])
C1517194 (UMLS CUI [3,2])
Metal foreign body in head Outside Mouth
Item
history of any metal in the head (outside the mouth).
boolean
C0561024 (UMLS CUI [1,1])
C0205101 (UMLS CUI [1,2])
C0230028 (UMLS CUI [1,3])
Particles Metallic Eye | Pacemaker, Cardiac, Implantable | Lines Intracardiac | Implantable Neurostimulators | Surgical Clips | Pump
Item
known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps
boolean
C0597177 (UMLS CUI [1,1])
C2986473 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
C0182148 (UMLS CUI [2])
C0700221 (UMLS CUI [3,1])
C0729936 (UMLS CUI [3,2])
C2048402 (UMLS CUI [4])
C0038917 (UMLS CUI [5])
C0182537 (UMLS CUI [6])
Frequent or severe headaches | Migraines Frequent | Migraines Severe
Item
history of frequent or severe headaches or migraines
boolean
C3842524 (UMLS CUI [1])
C0149931 (UMLS CUI [2,1])
C0332183 (UMLS CUI [2,2])
C0149931 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Hearing Loss | Cochlear Implants
Item
history of hearing loss or known history of cochlear implants.
boolean
C3887873 (UMLS CUI [1])
C0009199 (UMLS CUI [2])
Pregnancy | Contraceptive methods Absent
Item
pregnancy or not using a reliable method of birth control.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Study Subject Participation Status
Item
participation in another clinical trial within 30 days of this study
boolean
C2348568 (UMLS CUI [1])
Motor Threshold Determination Unable | Motor Threshold Quantification Unable | rTMS Protocol
Item
inability to locate and quantify a motor threshold (mt) as defined by the rtms protocol
boolean
C0501384 (UMLS CUI [1,1])
C0449864 (UMLS CUI [1,2])
C1148554 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0501384 (UMLS CUI [2,1])
C0449864 (UMLS CUI [2,2])
C1709793 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0872259 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
Pharmaceutical Preparations Causing Lowered convulsive threshold | Stimulant | Wellbutrin | Bupropion | Tricyclic Antidepressive Agents | Clomipramine | Maprotiline
Item
current use of drugs known to lower seizure threshold, such as stimulants, wellbutrin, bupropion, and certain tricyclics (e.g. clomipramine and maprotiline)
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0234976 (UMLS CUI [1,3])
C0304402 (UMLS CUI [2])
C0085934 (UMLS CUI [3])
C0085208 (UMLS CUI [4])
C0003290 (UMLS CUI [5])
C0009010 (UMLS CUI [6])
C0024778 (UMLS CUI [7])
Handedness
Item
left-handed
boolean
C0023114 (UMLS CUI [1])
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