ID

15057

Beschreibung

A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}; ODM derived from: https://clinicaltrials.gov/show/NCT02358343

Link

https://clinicaltrials.gov/show/NCT02358343

Stichworte

Versionen (1)
  1. 13.05.16 13.05.16 -
Hochgeladen am

13. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Depression NCT02358343

Englisch

Eligibility Depression NCT02358343

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02358343
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥ 21 years;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. undergoing thrice-weekly maintenance hd for ≥ 3 months;
Beschreibung

Hemodialysis Maintenance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0024501
3. able to speak either english or spanish;
Beschreibung

Able to speak English Language | Able to speak Spanish Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0037750
4. bdi-ii score ≥ 15; and
Beschreibung

Beck depression inventory score

Datentyp

boolean

Alias
UMLS CUI [1]
C2960571
5. meets diagnostic criteria for either current major depressive episode or dysthymia on the mini.
Beschreibung

Single major depressive episode | Dysthymic Disorder | Diagnostic Criteria Met

Datentyp

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0013415
UMLS CUI [3]
C3897171
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active suicidal intent;
Beschreibung

Suicidal intent

Datentyp

boolean

Alias
UMLS CUI [1]
C0582496
2. ongoing psychotherapy or current treatment with anti-depressant drugs;
Beschreibung

Psychotherapy Continuous | Therapeutic procedure Antidepressive Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0003289
3. evidence of cognitive impairment on mini-cog;
Beschreibung

Cognitive impairment Mini-Cog

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1839000
UMLS CUI [1,2]
C3496553
4. present or past psychosis or bipolar disorder i or ii on the mini;
Beschreibung

Psychotic Disorders | Bipolar I disorder | Bipolar II disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0853193
UMLS CUI [3]
C0236788
5. alcohol or substance abuse diagnosed on the mini or history of such abuse in the past three months;
Beschreibung

Substance Use Disorders | History of substance abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C1299544
6. life expectancy < 3 months, in the judgment of the site principal investigator;
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
7. anticipated to receive living related donor kidney transplantation within 3 months;
Beschreibung

Patient awaiting renal transplant Renal transplant living donor related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3472678
UMLS CUI [1,2]
C2170315
8. pregnancy, or lactation, or women of childbearing age not willing to use adequate birth control;
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Age | Unwilling Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0001779
UMLS CUI [4,1]
C0558080
UMLS CUI [4,2]
C0700589
9. clinical and/or laboratory evidence of chronic liver disease;
Beschreibung

Chronic liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0341439
10. history of significant active bleeding in the past three months, such as hospitalization for gastrointestinal bleeding;
Beschreibung

Hemorrhage | Hospitalization Gastrointestinal Hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0017181
11. current use of class i anti-arrhythmic medications (e.g., propafenone, flecainide), pimozide, monoamine oxidase inhibitors, reserpine, guanethidine, cimetidine, tri-cyclic anti-depressants, triptans, tramadol, linezolid, tryptophan, and st. john's wort; and
Beschreibung

Class I antiarrhythmic drug | Propafenone | Flecainide | Pimozide | Monoamine Oxidase Inhibitors | Reserpine | Guanethidine | Cimetidine | Tricyclic Antidepressive Agents | Serotonin 5-HT1 Receptor Agonists | Tramadol | linezolid | Tryptophan | ST. JOHN'S WORT EXTRACT

Datentyp

boolean

Alias
UMLS CUI [1]
C0360692
UMLS CUI [2]
C0033429
UMLS CUI [3]
C0016229
UMLS CUI [4]
C0031935
UMLS CUI [5]
C0026457
UMLS CUI [6]
C0035179
UMLS CUI [7]
C0018318
UMLS CUI [8]
C0008783
UMLS CUI [9]
C0003290
UMLS CUI [10]
C0162754
UMLS CUI [11]
C0040610
UMLS CUI [12]
C0663241
UMLS CUI [13]
C0041249
UMLS CUI [14]
C0813171
12. known hypersensitivity to sertraline.
Beschreibung

Hypersensitivity Sertraline

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0074393
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Ähnliche Modelle

Eligibility Depression NCT02358343

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02358343
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥ 21 years;
boolean
C0001779 (UMLS CUI [1])
Hemodialysis Maintenance
Item
2. undergoing thrice-weekly maintenance hd for ≥ 3 months;
boolean
C0019004 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
Able to speak English Language | Able to speak Spanish Language
Item
3. able to speak either english or spanish;
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Beck depression inventory score
Item
4. bdi-ii score ≥ 15; and
boolean
C2960571 (UMLS CUI [1])
Single major depressive episode | Dysthymic Disorder | Diagnostic Criteria Met
Item
5. meets diagnostic criteria for either current major depressive episode or dysthymia on the mini.
boolean
C0024517 (UMLS CUI [1])
C0013415 (UMLS CUI [2])
C3897171 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Suicidal intent
Item
1. active suicidal intent;
boolean
C0582496 (UMLS CUI [1])
Psychotherapy Continuous | Therapeutic procedure Antidepressive Agents
Item
2. ongoing psychotherapy or current treatment with anti-depressant drugs;
boolean
C0033968 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0003289 (UMLS CUI [2,2])
Cognitive impairment Mini-Cog
Item
3. evidence of cognitive impairment on mini-cog;
boolean
C1839000 (UMLS CUI [1,1])
C3496553 (UMLS CUI [1,2])
Psychotic Disorders | Bipolar I disorder | Bipolar II disorder
Item
4. present or past psychosis or bipolar disorder i or ii on the mini;
boolean
C0033975 (UMLS CUI [1])
C0853193 (UMLS CUI [2])
C0236788 (UMLS CUI [3])
Substance Use Disorders | History of substance abuse
Item
5. alcohol or substance abuse diagnosed on the mini or history of such abuse in the past three months;
boolean
C0038586 (UMLS CUI [1])
C1299544 (UMLS CUI [2])
Life Expectancy
Item
6. life expectancy < 3 months, in the judgment of the site principal investigator;
boolean
C0023671 (UMLS CUI [1])
Patient awaiting renal transplant Renal transplant living donor related
Item
7. anticipated to receive living related donor kidney transplantation within 3 months;
boolean
C3472678 (UMLS CUI [1,1])
C2170315 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Age | Unwilling Contraceptive methods
Item
8. pregnancy, or lactation, or women of childbearing age not willing to use adequate birth control;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
C0558080 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Chronic liver disease
Item
9. clinical and/or laboratory evidence of chronic liver disease;
boolean
C0341439 (UMLS CUI [1])
Hemorrhage | Hospitalization Gastrointestinal Hemorrhage
Item
10. history of significant active bleeding in the past three months, such as hospitalization for gastrointestinal bleeding;
boolean
C0019080 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C0017181 (UMLS CUI [2,2])
Class I antiarrhythmic drug | Propafenone | Flecainide | Pimozide | Monoamine Oxidase Inhibitors | Reserpine | Guanethidine | Cimetidine | Tricyclic Antidepressive Agents | Serotonin 5-HT1 Receptor Agonists | Tramadol | linezolid | Tryptophan | ST. JOHN'S WORT EXTRACT
Item
11. current use of class i anti-arrhythmic medications (e.g., propafenone, flecainide), pimozide, monoamine oxidase inhibitors, reserpine, guanethidine, cimetidine, tri-cyclic anti-depressants, triptans, tramadol, linezolid, tryptophan, and st. john's wort; and
boolean
C0360692 (UMLS CUI [1])
C0033429 (UMLS CUI [2])
C0016229 (UMLS CUI [3])
C0031935 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
C0035179 (UMLS CUI [6])
C0018318 (UMLS CUI [7])
C0008783 (UMLS CUI [8])
C0003290 (UMLS CUI [9])
C0162754 (UMLS CUI [10])
C0040610 (UMLS CUI [11])
C0663241 (UMLS CUI [12])
C0041249 (UMLS CUI [13])
C0813171 (UMLS CUI [14])
Hypersensitivity Sertraline
Item
12. known hypersensitivity to sertraline.
boolean
C0020517 (UMLS CUI [1,1])
C0074393 (UMLS CUI [1,2])
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