ID

30464

Beskrivning

A Double-Blind Sham Controlled Trial of rTMS in Treatment Resistant Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00402220

Länk

https://clinicaltrials.gov/show/NCT00402220

Nyckelord

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

See clinicaltrials.gov

Uppladdad den

6 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00402220

Engelsk

Eligibility Major Depressive Disorder NCT00402220

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients will be included if they:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. have a dsm-iv diagnosis of a major depressive episode (scid 11).
Beskrivning

Major depressive episode

Datatyp

boolean

Alias
UMLS CUI [1]
C0024517
2. aged 18-85.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. have treatment resistant depression at stage ii of the thase and rush classification [31]; .e. have failed to achieve a clinical response, or did not tolerate, at least two separate antidepressant trials of sufficient dose for at least 6 weeks.
Beskrivning

Depressive disorder Unresponsive to Treatment Other Coding | Clinical Response failed | Intolerance to Antidepressive Agents Dosage Sufficient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C3846158
UMLS CUI [2,1]
C4055223
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0003289
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205410
4. have a hamilton depression rating scale score of > 20 (moderate - severe depression). including only a severely ill group of subjects limits the placebo response rate [32]. moreover, this will allow us to address the application of rtms methods in the most clinically relevant subgroup of patients (in addition helping to constrain group heterogeneity, a major issue in depression research).
Beskrivning

Moderately severe depression Hamilton rating scale for depression | Group as study subject Illness Severe | Limitation Placebo Response rate | Transcranial Magnetic Stimulation, Repetitive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4304583
UMLS CUI [1,2]
C0451203
UMLS CUI [2,1]
C0681860
UMLS CUI [2,2]
C0221423
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0449295
UMLS CUI [3,2]
C0032042
UMLS CUI [3,3]
C0237629
UMLS CUI [4]
C0872259
5. have had no increase or initiation of new antidepressant (or other psychoactive) therapy in the 4 weeks prior to screening.
Beskrivning

Absence Increase Antidepressive Agents | Absence Increase Psychotropic Drugs | Absence Antidepressive Agents New | Absence Psychotropic Drugs New

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0442805
UMLS CUI [1,3]
C0003289
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0442805
UMLS CUI [2,3]
C0033978
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0003289
UMLS CUI [3,3]
C0205314
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0033978
UMLS CUI [4,3]
C0205314
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating.
Beskrivning

Medical condition Unstable | Nervous system disorder | Epilepsy | Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0032961
UMLS CUI [5]
C0006147
2. in the opinion of the investigator, are a sufficient suicidal risk to require immediate electro-convulsive therapy.
Beskrivning

At risk for suicide | Requirement Electroconvulsive Therapy Immediate

Datatyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013806
UMLS CUI [2,3]
C0205253
3. have a current dsm iv diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder (scid ii) or another axis 1 disorder.
Beskrivning

Substance Use Disorders | Substance Dependence | Personality Disorders | Axis I diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3]
C0031212
UMLS CUI [4]
C0270287
please note: several of these criteria (e.g. inclusion criteria 1 & 2, exclusion criteria 3) have been selected to explicitly constrain the heterogeneity of the sample to increase the likely power of the study to detect differences between the groups given the potentially subtle difference between the treatment methods.
Beskrivning

Eligibility Criteria Heterogeneity Volunteer Sample

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0019409
UMLS CUI [1,3]
C0150095
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Similar models

Eligibility Major Depressive Disorder NCT00402220

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients will be included if they:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Major depressive episode
Item
1. have a dsm-iv diagnosis of a major depressive episode (scid 11).
boolean
C0024517 (UMLS CUI [1])
Age
Item
2. aged 18-85.
boolean
C0001779 (UMLS CUI [1])
Depressive disorder Unresponsive to Treatment Other Coding | Clinical Response failed | Intolerance to Antidepressive Agents Dosage Sufficient
Item
3. have treatment resistant depression at stage ii of the thase and rush classification [31]; .e. have failed to achieve a clinical response, or did not tolerate, at least two separate antidepressant trials of sufficient dose for at least 6 weeks.
boolean
C0011581 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
C4055223 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0003289 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205410 (UMLS CUI [3,4])
Moderately severe depression Hamilton rating scale for depression | Group as study subject Illness Severe | Limitation Placebo Response rate | Transcranial Magnetic Stimulation, Repetitive
Item
4. have a hamilton depression rating scale score of > 20 (moderate - severe depression). including only a severely ill group of subjects limits the placebo response rate [32]. moreover, this will allow us to address the application of rtms methods in the most clinically relevant subgroup of patients (in addition helping to constrain group heterogeneity, a major issue in depression research).
boolean
C4304583 (UMLS CUI [1,1])
C0451203 (UMLS CUI [1,2])
C0681860 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0449295 (UMLS CUI [3,1])
C0032042 (UMLS CUI [3,2])
C0237629 (UMLS CUI [3,3])
C0872259 (UMLS CUI [4])
Absence Increase Antidepressive Agents | Absence Increase Psychotropic Drugs | Absence Antidepressive Agents New | Absence Psychotropic Drugs New
Item
5. have had no increase or initiation of new antidepressant (or other psychoactive) therapy in the 4 weeks prior to screening.
boolean
C0332197 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
C0003289 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0442805 (UMLS CUI [2,2])
C0033978 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0003289 (UMLS CUI [3,2])
C0205314 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C0033978 (UMLS CUI [4,2])
C0205314 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Medical condition Unstable | Nervous system disorder | Epilepsy | Pregnancy | Breast Feeding
Item
1. patients who have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
At risk for suicide | Requirement Electroconvulsive Therapy Immediate
Item
2. in the opinion of the investigator, are a sufficient suicidal risk to require immediate electro-convulsive therapy.
boolean
C0563664 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0013806 (UMLS CUI [2,2])
C0205253 (UMLS CUI [2,3])
Substance Use Disorders | Substance Dependence | Personality Disorders | Axis I diagnosis
Item
3. have a current dsm iv diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder (scid ii) or another axis 1 disorder.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0031212 (UMLS CUI [3])
C0270287 (UMLS CUI [4])
Eligibility Criteria Heterogeneity Volunteer Sample
Item
please note: several of these criteria (e.g. inclusion criteria 1 & 2, exclusion criteria 3) have been selected to explicitly constrain the heterogeneity of the sample to increase the likely power of the study to detect differences between the groups given the potentially subtle difference between the treatment methods.
boolean
C1516637 (UMLS CUI [1,1])
C0019409 (UMLS CUI [1,2])
C0150095 (UMLS CUI [1,3])
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