ID

21766

Beschreibung

Are Two Antidepressants a Good Initial Treatment for Depression?; ODM derived from: https://clinicaltrials.gov/show/NCT00296712

Link

https://clinicaltrials.gov/show/NCT00296712

Stichworte

Versionen (1)
  1. 29.04.17 29.04.17 -
Hochgeladen am

29. April 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Major Depression NCT00296712

Englisch

Eligibility Major Depression NCT00296712

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
currently depressed (dsm-iv major depression, dysthymia or depression nos)
Beschreibung

Feeling depressed | Major Depressive Disorder | Dysthymic Disorder | Depressive disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0497307
UMLS CUI [2]
C1269683
UMLS CUI [3]
C0013415
UMLS CUI [4]
C0011581
hamd-d (21-item) > 9
Beschreibung

Hamilton rating scale for depression

Datentyp

boolean

Alias
UMLS CUI [1]
C0451203
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior ineffective adequate trial on either study medication ($ 4 weeks on either escitalopram >20 mg/d or bupropion >300 mg/d; >4 weeks on citalopram >40 mg/d)
Beschreibung

Clinical Trial Investigational New Drugs ineffective | Escitalopram | Bupropion | Citalopram

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C3242229
UMLS CUI [2]
C1099456
UMLS CUI [3]
C0085208
UMLS CUI [4]
C0008845
history suggesting increased risk for seizures (e.g., prior seizure as an adult, diagnosed seizure disorder, taking medication known to increase seizure risk, history of significant head trauma, history of bulimia or anorexia)
Beschreibung

Seizures Risk Increased | Seizures Adult | Epilepsy | Pharmaceutical Preparations Seizures Risk Increased | Craniocerebral Trauma | Bulimia | Anorexia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0205217
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0001675
UMLS CUI [3]
C0014544
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0036572
UMLS CUI [4,3]
C0035647
UMLS CUI [4,4]
C0205217
UMLS CUI [5]
C0018674
UMLS CUI [6]
C0006370
UMLS CUI [7]
C0003123
history of intolerance to either study medication unless patient and m.d. agree side effect is probably manageable
Beschreibung

Intolerance to Investigational New Drugs | Side effects manageable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C1446391
alcohol and/or drug abuse/dependence during past year
Beschreibung

Substance Use Disorders | Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
major medical problems that are not well controlled (e.g., untreated hypertension or diabetes)
Beschreibung

Medical Problem Major Uncontrolled | hypertension untreated | Diabetes Mellitus untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0745134
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C0332155
bipolar i, bipolar ii
Beschreibung

Bipolar I disorder | Bipolar II disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0853193
UMLS CUI [2]
C0236788
history of psychosis, or current psychosis
Beschreibung

Psychotic Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0033975
currently taking antidepressants or mood stabilizers, which is judged unwise to discontinue (occasional sleep medication or benzodiazepine for anxiety is allowed)
Beschreibung

Antidepressive Agents | Mood Stabilizer | taking medication to help sleep occasional | Benzodiazepine Anxiety

Datentyp

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C2917435
UMLS CUI [3,1]
C2054158
UMLS CUI [3,2]
C0521114
UMLS CUI [4,1]
C4048284
UMLS CUI [4,2]
C0003467
not currently depressed (whether considered due to current treatment or not)
Beschreibung

Feeling depressed Absent | Feeling depressed Absent Due to Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497307
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0497307
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0087111
active suicidal risk (history of suicide attempts will be evaluated on a case by case basis)
Beschreibung

At risk for suicide | Suicide attempt Evaluation

Datentyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0038663
UMLS CUI [2,2]
C1261322
pregnant or breast-feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
premenopausal women not using known effective birth control
Beschreibung

Premenopausal state Contraceptive methods Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
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Ähnliche Modelle

Eligibility Major Depression NCT00296712

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Feeling depressed | Major Depressive Disorder | Dysthymic Disorder | Depressive disorder
Item
currently depressed (dsm-iv major depression, dysthymia or depression nos)
boolean
C0497307 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C0013415 (UMLS CUI [3])
C0011581 (UMLS CUI [4])
Hamilton rating scale for depression
Item
hamd-d (21-item) > 9
boolean
C0451203 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Clinical Trial Investigational New Drugs ineffective | Escitalopram | Bupropion | Citalopram
Item
prior ineffective adequate trial on either study medication ($ 4 weeks on either escitalopram >20 mg/d or bupropion >300 mg/d; >4 weeks on citalopram >40 mg/d)
boolean
C0008976 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C3242229 (UMLS CUI [1,3])
C1099456 (UMLS CUI [2])
C0085208 (UMLS CUI [3])
C0008845 (UMLS CUI [4])
Seizures Risk Increased | Seizures Adult | Epilepsy | Pharmaceutical Preparations Seizures Risk Increased | Craniocerebral Trauma | Bulimia | Anorexia
Item
history suggesting increased risk for seizures (e.g., prior seizure as an adult, diagnosed seizure disorder, taking medication known to increase seizure risk, history of significant head trauma, history of bulimia or anorexia)
boolean
C0036572 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
C0036572 (UMLS CUI [2,1])
C0001675 (UMLS CUI [2,2])
C0014544 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0036572 (UMLS CUI [4,2])
C0035647 (UMLS CUI [4,3])
C0205217 (UMLS CUI [4,4])
C0018674 (UMLS CUI [5])
C0006370 (UMLS CUI [6])
C0003123 (UMLS CUI [7])
Intolerance to Investigational New Drugs | Side effects manageable
Item
history of intolerance to either study medication unless patient and m.d. agree side effect is probably manageable
boolean
C1744706 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0879626 (UMLS CUI [2,1])
C1446391 (UMLS CUI [2,2])
Substance Use Disorders | Substance Dependence
Item
alcohol and/or drug abuse/dependence during past year
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Medical Problem Major Uncontrolled | hypertension untreated | Diabetes Mellitus untreated
Item
major medical problems that are not well controlled (e.g., untreated hypertension or diabetes)
boolean
C1254481 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0745134 (UMLS CUI [2])
C0011849 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Bipolar I disorder | Bipolar II disorder
Item
bipolar i, bipolar ii
boolean
C0853193 (UMLS CUI [1])
C0236788 (UMLS CUI [2])
Psychotic Disorder
Item
history of psychosis, or current psychosis
boolean
C0033975 (UMLS CUI [1])
Antidepressive Agents | Mood Stabilizer | taking medication to help sleep occasional | Benzodiazepine Anxiety
Item
currently taking antidepressants or mood stabilizers, which is judged unwise to discontinue (occasional sleep medication or benzodiazepine for anxiety is allowed)
boolean
C0003289 (UMLS CUI [1])
C2917435 (UMLS CUI [2])
C2054158 (UMLS CUI [3,1])
C0521114 (UMLS CUI [3,2])
C4048284 (UMLS CUI [4,1])
C0003467 (UMLS CUI [4,2])
Feeling depressed Absent | Feeling depressed Absent Due to Therapeutic procedure
Item
not currently depressed (whether considered due to current treatment or not)
boolean
C0497307 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0497307 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
At risk for suicide | Suicide attempt Evaluation
Item
active suicidal risk (history of suicide attempts will be evaluated on a case by case basis)
boolean
C0563664 (UMLS CUI [1])
C0038663 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Premenopausal state Contraceptive methods Lacking
Item
premenopausal women not using known effective birth control
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
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