ID

30531

Beschreibung

Biomarkers for Outcomes In Late-life Depression (BOLD); ODM derived from: https://clinicaltrials.gov/show/NCT01082237

Link

https://clinicaltrials.gov/show/NCT01082237

Stichworte

Versionen (1)
  1. 12.06.18 12.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

12. Juni 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT01082237

Englisch

Eligibility Major Depressive Disorder NCT01082237

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
62 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
meet the dsm-iv diagnosis of mdd based on sheehan's mini-international neuropsychiatric interview (mini), with a score of > 28 on the 30-item inventory of depressive symptomatology - self rated version (ids-sr30)
Beschreibung

Major Depressive Disorder Inventory of Depressive Symptomatology Self-Report Version Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C4330497
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects will have no unstable medical illness that would prevent completion of participation in the trial, determined as needed from physical examination, ecg, laboratory safety tests, as well as a review of systems
Beschreibung

Illness Unstable Preventing Completion of clinical trial | Physical Examination | Electrocardiography | Laboratory Procedures Safety | Review of systems

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C2732579
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0013798
UMLS CUI [4,1]
C0022885
UMLS CUI [4,2]
C0036043
UMLS CUI [5]
C0489633
mentally or legally incapacitated, unable to give informed consent
Beschreibung

Legal capacity Lacking | Mental handicap | Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
UMLS CUI [2]
C1306341
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
meets dsm-iv criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major depression with psychotic features
Beschreibung

Anorexia Nervosa | Bulimia Nervosa | Obsessive-Compulsive Disorder | Cognition Disorders | Bipolar Disorder | Psychotic Disorders | Major depression with psychotic features

Datentyp

boolean

Alias
UMLS CUI [1]
C0003125
UMLS CUI [2]
C2267227
UMLS CUI [3]
C0028768
UMLS CUI [4]
C0009241
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0033975
UMLS CUI [7]
C4518519
mmse (folstein et al., 1975) score ≤ 24
Beschreibung

Mini-mental state examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0451306
evidence of drug dependency or substance abuse within the preceding nine months
Beschreibung

Drug Dependence | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C1510472
UMLS CUI [2]
C0038586
stable and in remission on current psychotropic medication(s)
Beschreibung

Stable status | Remission | Psychotropic Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0205360
UMLS CUI [2]
C0544452
UMLS CUI [3]
C0033978
any ect within the past six months
Beschreibung

Electroconvulsive Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013806
failure to tolerate esc or treatment failure with an adequate trial of esc in the current episode
Beschreibung

Intolerance to Escitalopram | Treatment failure Depressive episode | Escitalopram

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1099456
UMLS CUI [2,1]
C0162643
UMLS CUI [2,2]
C0349217
UMLS CUI [3]
C1099456
esc would be contraindicated (e.g., hyponatremia with a prior ssri)
Beschreibung

Medical contraindication Escitalopram | Hyponatremia Associated with Selective Serotonin Reuptake Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1099456
UMLS CUI [2,1]
C0020625
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0360105
treatment with fluoxetine or an maoi within the past four weeks
Beschreibung

Fluoxetine | Monoamine Oxidase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0016365
UMLS CUI [2]
C0026457
any medical illness severe enough to significantly affect brain function or to interfere with interpretation of study results
Beschreibung

Illness Severe Affecting Brain function | Illness Interferes with Interpretation Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0678908
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0683954
history of seizures, brain surgery, skull fracture, significant head trauma, or abnormal eeg
Beschreibung

Seizures | Operation on brain | Skull Fractures | Craniocerebral Trauma | Electroencephalogram abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0195775
UMLS CUI [3]
C0037304
UMLS CUI [4]
C0018674
UMLS CUI [5]
C0151611
psychiatric hospitalization indicated (e.g., imminent danger to self or others)
Beschreibung

Indication Psychiatric hospitalization | DANGER OF HARM TO SELF | At risk of harming others

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0748061
UMLS CUI [2]
C0149660
UMLS CUI [3]
C1271966
initial qeeg recording is contaminated with artifact so that determination of the biomarker is precluded
Beschreibung

Electroencephalography Quantitative Unsuccessful | Biomarkers Determination Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013819
UMLS CUI [1,2]
C0392762
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C0521095
UMLS CUI [2,3]
C0332196
use of medications known to affect brain function (e.g., antidepressants, anticonvulsants/mood stabilizers, anticholinergics, antipsychotics, benzodiazepines -
Beschreibung

Pharmaceutical Preparations Affecting Brain function | Antidepressive Agents | Anticonvulsants | Mood Stabilizer | Anticholinergic Agents | Antipsychotic Agents | Benzodiazepines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678908
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0003286
UMLS CUI [4]
C2917435
UMLS CUI [5]
C0242896
UMLS CUI [6]
C0040615
UMLS CUI [7]
C0005064
same list as in brite-md)
Beschreibung

Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C3846158
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Ähnliche Modelle

Eligibility Major Depressive Disorder NCT01082237

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
62 years of age or older
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder Inventory of Depressive Symptomatology Self-Report Version Questionnaire
Item
meet the dsm-iv diagnosis of mdd based on sheehan's mini-international neuropsychiatric interview (mini), with a score of > 28 on the 30-item inventory of depressive symptomatology - self rated version (ids-sr30)
boolean
C1269683 (UMLS CUI [1,1])
C4330497 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Illness Unstable Preventing Completion of clinical trial | Physical Examination | Electrocardiography | Laboratory Procedures Safety | Review of systems
Item
subjects will have no unstable medical illness that would prevent completion of participation in the trial, determined as needed from physical examination, ecg, laboratory safety tests, as well as a review of systems
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
C0031809 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
C0022885 (UMLS CUI [4,1])
C0036043 (UMLS CUI [4,2])
C0489633 (UMLS CUI [5])
Legal capacity Lacking | Mental handicap | Informed Consent Unable
Item
mentally or legally incapacitated, unable to give informed consent
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C1306341 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Anorexia Nervosa | Bulimia Nervosa | Obsessive-Compulsive Disorder | Cognition Disorders | Bipolar Disorder | Psychotic Disorders | Major depression with psychotic features
Item
meets dsm-iv criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major depression with psychotic features
boolean
C0003125 (UMLS CUI [1])
C2267227 (UMLS CUI [2])
C0028768 (UMLS CUI [3])
C0009241 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
C4518519 (UMLS CUI [7])
Mini-mental state examination
Item
mmse (folstein et al., 1975) score ≤ 24
boolean
C0451306 (UMLS CUI [1])
Drug Dependence | Substance Use Disorders
Item
evidence of drug dependency or substance abuse within the preceding nine months
boolean
C1510472 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Stable status | Remission | Psychotropic Drugs
Item
stable and in remission on current psychotropic medication(s)
boolean
C0205360 (UMLS CUI [1])
C0544452 (UMLS CUI [2])
C0033978 (UMLS CUI [3])
Electroconvulsive Therapy
Item
any ect within the past six months
boolean
C0013806 (UMLS CUI [1])
Intolerance to Escitalopram | Treatment failure Depressive episode | Escitalopram
Item
failure to tolerate esc or treatment failure with an adequate trial of esc in the current episode
boolean
C1744706 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C0162643 (UMLS CUI [2,1])
C0349217 (UMLS CUI [2,2])
C1099456 (UMLS CUI [3])
Medical contraindication Escitalopram | Hyponatremia Associated with Selective Serotonin Reuptake Inhibitors
Item
esc would be contraindicated (e.g., hyponatremia with a prior ssri)
boolean
C1301624 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C0020625 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0360105 (UMLS CUI [2,3])
Fluoxetine | Monoamine Oxidase Inhibitors
Item
treatment with fluoxetine or an maoi within the past four weeks
boolean
C0016365 (UMLS CUI [1])
C0026457 (UMLS CUI [2])
Illness Severe Affecting Brain function | Illness Interferes with Interpretation Research results
Item
any medical illness severe enough to significantly affect brain function or to interfere with interpretation of study results
boolean
C0221423 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0678908 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Seizures | Operation on brain | Skull Fractures | Craniocerebral Trauma | Electroencephalogram abnormal
Item
history of seizures, brain surgery, skull fracture, significant head trauma, or abnormal eeg
boolean
C0036572 (UMLS CUI [1])
C0195775 (UMLS CUI [2])
C0037304 (UMLS CUI [3])
C0018674 (UMLS CUI [4])
C0151611 (UMLS CUI [5])
Indication Psychiatric hospitalization | DANGER OF HARM TO SELF | At risk of harming others
Item
psychiatric hospitalization indicated (e.g., imminent danger to self or others)
boolean
C3146298 (UMLS CUI [1,1])
C0748061 (UMLS CUI [1,2])
C0149660 (UMLS CUI [2])
C1271966 (UMLS CUI [3])
Electroencephalography Quantitative Unsuccessful | Biomarkers Determination Excluded
Item
initial qeeg recording is contaminated with artifact so that determination of the biomarker is precluded
boolean
C0013819 (UMLS CUI [1,1])
C0392762 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0005516 (UMLS CUI [2,1])
C0521095 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Pharmaceutical Preparations Affecting Brain function | Antidepressive Agents | Anticonvulsants | Mood Stabilizer | Anticholinergic Agents | Antipsychotic Agents | Benzodiazepines
Item
use of medications known to affect brain function (e.g., antidepressants, anticonvulsants/mood stabilizers, anticholinergics, antipsychotics, benzodiazepines -
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678908 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
C2917435 (UMLS CUI [4])
C0242896 (UMLS CUI [5])
C0040615 (UMLS CUI [6])
C0005064 (UMLS CUI [7])
Other Coding
Item
same list as in brite-md)
boolean
C3846158 (UMLS CUI [1])
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