ID

30432

Beschrijving

Efficacy Study of Escitalopram for Depression in Patients With Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00650897

Link

https://clinicaltrials.gov/show/NCT00650897

Trefwoorden

Versies (1)
  1. 05-06-18 05-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 juni 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Major Depression NCT00650897

Engels

Eligibility Major Depression NCT00650897

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of type-1 or type-2 diabetes mellitus (excluding gestational diabetes) by a specialist at least 6 months prior to the study.
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Gestational Diabetes Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0085207
UMLS CUI [3,2]
C0332196
current diagnosis of major depression based on dsm-iv criteria .
Beschrijving

Major Depressive Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
hamilton depression rating scale (hamd) baseline score > 17
Beschrijving

Hamilton rating scale for depression

Datatype

boolean

Alias
UMLS CUI [1]
C0451203
available for 14-weeks of treatment and all evaluations.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
able to understand study rules and procedures and willing to sign written informed consent for study participation.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
competence: not competent to understand and sign informed consent forms and/or to understand and answer the evaluations.
Beschrijving

Informed Consent incompetent | Protocol Compliance incompetent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231190
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0231190
psychiatric exclusions: one or more of the following: alcohol or substance abuse or dependence in past 6 months; psychotic symptoms or history of psychosis; bipolar disorder; organic brain syndrome; significant suicide risk; homicidal thoughts.
Beschrijving

Substance Use Disorders | Substance Dependence | Psychotic symptom | Psychotic Disorders | Bipolar Disorder | Organic brain syndrome | At risk for suicide | Homicidal thoughts

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3]
C0871189
UMLS CUI [4]
C0033975
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0029221
UMLS CUI [7]
C0563664
UMLS CUI [8]
C0455204
medical exclusions: known intolerance or hypersensitivity to escitalopram or other ssri; pregnancy; breastfeeding; women of childbearing potential not using adequate contraception; significant renal or hepatic dysfunction (such that demands medical workup and/or regular follow up); resting heart rate less than 40/minute (or 50/minute if symptomatic); uncontrolled hypertension (systolic blood pressure >180 mm hg or diastolic blood pressure >100 mm hg); any acute or unstable medical condition that might interfere with the safe conduct of the study.
Beschrijving

Intolerance to Escitalopram | Hypersensitivity Escitalopram | Intolerance to Selective Serotonin Reuptake Inhibitors | Selective serotonin re-uptake inhibitor allergy | Pregnancy | Breast Feeding | Gender Contraceptive methods Absent | Renal dysfunction | Liver Dysfunction | Requirement Work up | Requirement Follow-up Regular | RESTING HEART RATE | Resting heart rate Symptomatic | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Medical condition Interferes with Completion of clinical trial | Medical condition Unstable Interferes with Completion of clinical trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1099456
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1099456
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0360105
UMLS CUI [4]
C0570765
UMLS CUI [5]
C0032961
UMLS CUI [6]
C0006147
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0700589
UMLS CUI [7,3]
C0332197
UMLS CUI [8]
C3279454
UMLS CUI [9]
C0086565
UMLS CUI [10,1]
C1514873
UMLS CUI [10,2]
C0750430
UMLS CUI [11,1]
C1514873
UMLS CUI [11,2]
C1522577
UMLS CUI [11,3]
C0205272
UMLS CUI [12]
C1821417
UMLS CUI [13,1]
C1821417
UMLS CUI [13,2]
C0231220
UMLS CUI [14]
C1868885
UMLS CUI [15]
C0871470
UMLS CUI [16]
C0428883
UMLS CUI [17,1]
C3843040
UMLS CUI [17,2]
C0521102
UMLS CUI [17,3]
C2732579
UMLS CUI [18,1]
C3843040
UMLS CUI [18,2]
C0443343
UMLS CUI [18,3]
C0521102
UMLS CUI [18,4]
C2732579
concomitant medication(s) exclusion: current use (within 2 weeks of enrollment) of one or more of the following: antidepressants; regular benzodiazepine; neuroleptics; anticonvulsants; reserpine; guanethidine; clonidine; methyldopa.
Beschrijving

Antidepressive Agents | Benzodiazepines Regular | Antipsychotic Agents | Anticonvulsants | Reserpine | Guanethidine | Clonidine | Methyldopa

Datatype

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C0005064
UMLS CUI [2,2]
C0205272
UMLS CUI [3]
C0040615
UMLS CUI [4]
C0003286
UMLS CUI [5]
C0035179
UMLS CUI [6]
C0018318
UMLS CUI [7]
C0009014
UMLS CUI [8]
C0025741
Terug naar het begin van de pagina

Similar models

Eligibility Major Depression NCT00650897

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Gestational Diabetes Excluded
Item
diagnosis of type-1 or type-2 diabetes mellitus (excluding gestational diabetes) by a specialist at least 6 months prior to the study.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0085207 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Major Depressive Disorder
Item
current diagnosis of major depression based on dsm-iv criteria .
boolean
C1269683 (UMLS CUI [1])
Hamilton rating scale for depression
Item
hamilton depression rating scale (hamd) baseline score > 17
boolean
C0451203 (UMLS CUI [1])
Protocol Compliance
Item
available for 14-weeks of treatment and all evaluations.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
able to understand study rules and procedures and willing to sign written informed consent for study participation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent incompetent | Protocol Compliance incompetent
Item
competence: not competent to understand and sign informed consent forms and/or to understand and answer the evaluations.
boolean
C0021430 (UMLS CUI [1,1])
C0231190 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0231190 (UMLS CUI [2,2])
Substance Use Disorders | Substance Dependence | Psychotic symptom | Psychotic Disorders | Bipolar Disorder | Organic brain syndrome | At risk for suicide | Homicidal thoughts
Item
psychiatric exclusions: one or more of the following: alcohol or substance abuse or dependence in past 6 months; psychotic symptoms or history of psychosis; bipolar disorder; organic brain syndrome; significant suicide risk; homicidal thoughts.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0871189 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0029221 (UMLS CUI [6])
C0563664 (UMLS CUI [7])
C0455204 (UMLS CUI [8])
Intolerance to Escitalopram | Hypersensitivity Escitalopram | Intolerance to Selective Serotonin Reuptake Inhibitors | Selective serotonin re-uptake inhibitor allergy | Pregnancy | Breast Feeding | Gender Contraceptive methods Absent | Renal dysfunction | Liver Dysfunction | Requirement Work up | Requirement Follow-up Regular | RESTING HEART RATE | Resting heart rate Symptomatic | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Medical condition Interferes with Completion of clinical trial | Medical condition Unstable Interferes with Completion of clinical trial
Item
medical exclusions: known intolerance or hypersensitivity to escitalopram or other ssri; pregnancy; breastfeeding; women of childbearing potential not using adequate contraception; significant renal or hepatic dysfunction (such that demands medical workup and/or regular follow up); resting heart rate less than 40/minute (or 50/minute if symptomatic); uncontrolled hypertension (systolic blood pressure >180 mm hg or diastolic blood pressure >100 mm hg); any acute or unstable medical condition that might interfere with the safe conduct of the study.
boolean
C1744706 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1099456 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0360105 (UMLS CUI [3,2])
C0570765 (UMLS CUI [4])
C0032961 (UMLS CUI [5])
C0006147 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
C3279454 (UMLS CUI [8])
C0086565 (UMLS CUI [9])
C1514873 (UMLS CUI [10,1])
C0750430 (UMLS CUI [10,2])
C1514873 (UMLS CUI [11,1])
C1522577 (UMLS CUI [11,2])
C0205272 (UMLS CUI [11,3])
C1821417 (UMLS CUI [12])
C1821417 (UMLS CUI [13,1])
C0231220 (UMLS CUI [13,2])
C1868885 (UMLS CUI [14])
C0871470 (UMLS CUI [15])
C0428883 (UMLS CUI [16])
C3843040 (UMLS CUI [17,1])
C0521102 (UMLS CUI [17,2])
C2732579 (UMLS CUI [17,3])
C3843040 (UMLS CUI [18,1])
C0443343 (UMLS CUI [18,2])
C0521102 (UMLS CUI [18,3])
C2732579 (UMLS CUI [18,4])
Antidepressive Agents | Benzodiazepines Regular | Antipsychotic Agents | Anticonvulsants | Reserpine | Guanethidine | Clonidine | Methyldopa
Item
concomitant medication(s) exclusion: current use (within 2 weeks of enrollment) of one or more of the following: antidepressants; regular benzodiazepine; neuroleptics; anticonvulsants; reserpine; guanethidine; clonidine; methyldopa.
boolean
C0003289 (UMLS CUI [1])
C0005064 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0040615 (UMLS CUI [3])
C0003286 (UMLS CUI [4])
C0035179 (UMLS CUI [5])
C0018318 (UMLS CUI [6])
C0009014 (UMLS CUI [7])
C0025741 (UMLS CUI [8])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial