ID

30432

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00650897

Palabras clave

Versiones (1)
  1. 5/6/18 5/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de junio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Major Depression NCT00650897

Inglés

Eligibility Major Depression NCT00650897

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years or older.
Descripción

Age

Tipo de datos

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.
Descripción

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

Tipo de datos

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 .
Descripción

Major Depressive Disorder

Tipo de datos

boolean

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

Hamilton rating scale for depression

Tipo de datos

boolean

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

Protocol Compliance

Tipo de datos

boolean

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

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Informed Consent incompetent | Protocol Compliance incompetent

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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
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Similar models

Eligibility Major Depression NCT00650897

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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