ID

17034

Description

Mifepristone in Refractory Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00186056

Link

https://clinicaltrials.gov/show/NCT00186056

Keywords

Versions (1)
  1. 8/22/16 8/22/16 -
Uploaded on

August 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00186056

English

Eligibility Depression NCT00186056

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00186056
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
21-item ham-d score of 20 or above.
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
if currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least three weeks prior to entering the study.
Description

Antipsychotic Agents | Antidepressive Agents | Anticonvulsants | Mood stabilizing drug | Pharmaceutical Preparations Stable

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0003286
UMLS CUI [4]
C1276998
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0205360
at least 2 failed antidepressant medication trials of adequate dose and duration.
Description

Antidepressive Agents Trials Quantity failed | Antidepressive Agents Dosage | Antidepressive Agents Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231175
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0003289
UMLS CUI [3,2]
C0449238
between 18 and 75 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
not currently pregnant or trying to become pregnant.
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of schizophrenia or other psychotic disorders.
Description

Schizophrenia | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0033975
transcranial magnetic stimulation treatment or ect in the 3 months prior to starting the study.
Description

Transcranial magnetic stimulation | Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0436548
UMLS CUI [2]
C0013806
history of vagus nerve stimulation treatment.
Description

Vagus Nerve Stimulation

Data type

boolean

Alias
UMLS CUI [1]
C2350432
no unstable or untreated cardiovascular disease, hypertension, or endocrine disorder.
Description

Cardiovascular Disease Unstable | Hypertensive disease Unstable | Endocrine System Disease Unstable | Cardiovascular Disease untreated | Hypertensive disease untreated | Endocrine System Disease untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0014130
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0007222
UMLS CUI [4,2]
C0332155
UMLS CUI [5,1]
C0020538
UMLS CUI [5,2]
C0332155
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C0332155
current use of oral contraceptives or any other drug that may result in adverse drug-mifepristone interactions effects (including amiodarone, clarithromycin, erythromycin, fluconazole, fluvoxamine, indinavir, intraconazole, ketoconazole, metronidazole, miconazole, nefazodone, nelfinavir, norfloxacin, omeprazole, quinine, ritonavir, saquinavir, troleandomycin, zafirlukast, carbamazepine, dexamethasone, ethosuximide, phenobarbital, phenytoin, primidone, rifabutin, rifampin, troglitazone). a 30-day wash-out period for oral contraceptives is required before mifepristone begins.
Description

Oral Contraceptives Resulting in Mifepristone adverse reaction | Pharmaceutical Preparations Resulting in Mifepristone adverse reaction | Amiodarone | Clarithromycin | Erythromycin | Fluconazole | Fluvoxamine | Indinavir | Itraconazole | Ketoconazole | Metronidazole | Miconazole | nefazodone | Nelfinavir | Norfloxacin | Omeprazole | Quinine | Ritonavir | Saquinavir | Troleandomycin | zafirlukast | Carbamazepine | Dexamethasone | Ethosuximide | Phenobarbital | Phenytoin | Primidone | Rifabutin | Rifampin | troglitazone | Washout Period | Mifepristone

Data type

boolean

Alias
UMLS CUI [1,1]
C0009905
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0569852
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0569852
UMLS CUI [3]
C0002598
UMLS CUI [4]
C0055856
UMLS CUI [5]
C0014806
UMLS CUI [6]
C0016277
UMLS CUI [7]
C0085228
UMLS CUI [8]
C0376637
UMLS CUI [9]
C0064113
UMLS CUI [10]
C0022625
UMLS CUI [11]
C0025872
UMLS CUI [12]
C0025942
UMLS CUI [13]
C0068485
UMLS CUI [14]
C0525005
UMLS CUI [15]
C0028365
UMLS CUI [16]
C0028978
UMLS CUI [17]
C0034417
UMLS CUI [18]
C0292818
UMLS CUI [19]
C0286738
UMLS CUI [20]
C0041165
UMLS CUI [21]
C0378466
UMLS CUI [22]
C0006949
UMLS CUI [23]
C0011777
UMLS CUI [24]
C0015043
UMLS CUI [25]
C0031412
UMLS CUI [26]
C0031507
UMLS CUI [27]
C0033148
UMLS CUI [28]
C0140575
UMLS CUI [29]
C0035608
UMLS CUI [30]
C0245514
UMLS CUI [31]
C1710661
UMLS CUI [32]
C0026088
previous allergic reaction to mifepristone or drugs of similar chemical structure.
Description

Mifepristone allergy | Allergic Reaction Pharmaceutical Preparations Chemical Structure Similar

Data type

boolean

Alias
UMLS CUI [1]
C0571161
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0220807
UMLS CUI [2,4]
C2348205
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Similar models

Eligibility Depression NCT00186056

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00186056
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hamilton rating scale for depression
Item
21-item ham-d score of 20 or above.
boolean
C0451203 (UMLS CUI [1])
Antipsychotic Agents | Antidepressive Agents | Anticonvulsants | Mood stabilizing drug | Pharmaceutical Preparations Stable
Item
if currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least three weeks prior to entering the study.
boolean
C0040615 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
C1276998 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
Antidepressive Agents Trials Quantity failed | Antidepressive Agents Dosage | Antidepressive Agents Duration
Item
at least 2 failed antidepressant medication trials of adequate dose and duration.
boolean
C0003289 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0003289 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0003289 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Age
Item
between 18 and 75 years of age.
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
not currently pregnant or trying to become pregnant.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Schizophrenia | Psychotic Disorders
Item
history of schizophrenia or other psychotic disorders.
boolean
C0036341 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
Transcranial magnetic stimulation | Electroconvulsive Therapy
Item
transcranial magnetic stimulation treatment or ect in the 3 months prior to starting the study.
boolean
C0436548 (UMLS CUI [1])
C0013806 (UMLS CUI [2])
Vagus Nerve Stimulation
Item
history of vagus nerve stimulation treatment.
boolean
C2350432 (UMLS CUI [1])
Cardiovascular Disease Unstable | Hypertensive disease Unstable | Endocrine System Disease Unstable | Cardiovascular Disease untreated | Hypertensive disease untreated | Endocrine System Disease untreated
Item
no unstable or untreated cardiovascular disease, hypertension, or endocrine disorder.
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0014130 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0007222 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0020538 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
C0014130 (UMLS CUI [6,1])
C0332155 (UMLS CUI [6,2])
Oral Contraceptives Resulting in Mifepristone adverse reaction | Pharmaceutical Preparations Resulting in Mifepristone adverse reaction | Amiodarone | Clarithromycin | Erythromycin | Fluconazole | Fluvoxamine | Indinavir | Itraconazole | Ketoconazole | Metronidazole | Miconazole | nefazodone | Nelfinavir | Norfloxacin | Omeprazole | Quinine | Ritonavir | Saquinavir | Troleandomycin | zafirlukast | Carbamazepine | Dexamethasone | Ethosuximide | Phenobarbital | Phenytoin | Primidone | Rifabutin | Rifampin | troglitazone | Washout Period | Mifepristone
Item
current use of oral contraceptives or any other drug that may result in adverse drug-mifepristone interactions effects (including amiodarone, clarithromycin, erythromycin, fluconazole, fluvoxamine, indinavir, intraconazole, ketoconazole, metronidazole, miconazole, nefazodone, nelfinavir, norfloxacin, omeprazole, quinine, ritonavir, saquinavir, troleandomycin, zafirlukast, carbamazepine, dexamethasone, ethosuximide, phenobarbital, phenytoin, primidone, rifabutin, rifampin, troglitazone). a 30-day wash-out period for oral contraceptives is required before mifepristone begins.
boolean
C0009905 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0569852 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0569852 (UMLS CUI [2,3])
C0002598 (UMLS CUI [3])
C0055856 (UMLS CUI [4])
C0014806 (UMLS CUI [5])
C0016277 (UMLS CUI [6])
C0085228 (UMLS CUI [7])
C0376637 (UMLS CUI [8])
C0064113 (UMLS CUI [9])
C0022625 (UMLS CUI [10])
C0025872 (UMLS CUI [11])
C0025942 (UMLS CUI [12])
C0068485 (UMLS CUI [13])
C0525005 (UMLS CUI [14])
C0028365 (UMLS CUI [15])
C0028978 (UMLS CUI [16])
C0034417 (UMLS CUI [17])
C0292818 (UMLS CUI [18])
C0286738 (UMLS CUI [19])
C0041165 (UMLS CUI [20])
C0378466 (UMLS CUI [21])
C0006949 (UMLS CUI [22])
C0011777 (UMLS CUI [23])
C0015043 (UMLS CUI [24])
C0031412 (UMLS CUI [25])
C0031507 (UMLS CUI [26])
C0033148 (UMLS CUI [27])
C0140575 (UMLS CUI [28])
C0035608 (UMLS CUI [29])
C0245514 (UMLS CUI [30])
C1710661 (UMLS CUI [31])
C0026088 (UMLS CUI [32])
Mifepristone allergy | Allergic Reaction Pharmaceutical Preparations Chemical Structure Similar
Item
previous allergic reaction to mifepristone or drugs of similar chemical structure.
boolean
C0571161 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
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