ID

33104

Description

A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care; ODM derived from: https://clinicaltrials.gov/show/NCT00939250

Link

https://clinicaltrials.gov/show/NCT00939250

Keywords

Versions (1)
  1. 11/27/18 11/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 27, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00939250

English

Eligibility Type 2 Diabetes NCT00939250

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meets dsm-iv criteria for single or recurrent nonpsychotic mdd, and whom the physician deems it necessary to start on an antidepressant.
Description

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Recurrent | Requirement Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0743081
UMLS CUI [2,1]
C0743081
UMLS CUI [2,2]
C2945760
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0003289
meets clinical criteria for type 2 diabetes as follows: (1) on pharmacological treatment for type 2 diabetes and/or (2) fasting plasma glucose > 126mg/dl on 2 separate occasions or an abnormal oral glucose tolerance test (ogtt) (2-hours post load glucose ≥ 200mg/dl).
Description

Diabetes Mellitus, Non-Insulin-Dependent | Pharmacotherapy Non-Insulin-Dependent Diabetes Mellitus | Plasma fasting glucose measurement Quantity | Abnormal oral glucose tolerance test

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0011860
UMLS CUI [3,1]
C0583513
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C1847425
hba1c > 7
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
ability and willingness to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
hamilton rating scale for depression (hrsd) score ≥ 14
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
not on antidepressant medication for at least 2 weeks prior to screen (or 6 weeks in the case of fluoxetine or monoamine oxidase inhibitors - maois)
Description

Antidepressive Agents Absent | Fluoxetine Absent | Monoamine Oxidase Inhibitors Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0016365
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0026457
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
general medical conditions that contraindicate use of antidepressant medications
Description

Medical condition General | Medical contraindication Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205246
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0003289
unstable medical illnesses, such as uncontrolled hypertension or symptomatic cardiovascular disease, such as congestive heart failure or angina
Description

Illness Unstable | Uncontrolled hypertension | Cardiovascular Disease Symptomatic | Congestive heart failure | Angina Pectoris

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0002962
current or past psychotic disorders including bipolar disorder (i, ii, or nos), schizophrenia, or schizoaffective disorder; anorexia; bulimia
Description

Psychotic Disorders | Bipolar I disorder | Bipolar II disorder | Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Anorexia | Bulimia

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0853193
UMLS CUI [3]
C0236788
UMLS CUI [4]
C0005586
UMLS CUI [5]
C0036341
UMLS CUI [6]
C0036337
UMLS CUI [7]
C0003123
UMLS CUI [8]
C0006370
high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior
Description

High risk of Completion of clinical trial Unable | Hospitalization | Suicide attempt | Self Mutilation | Self-Injurious Behavior | Destructive behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C2732579
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0019993
UMLS CUI [3]
C0038663
UMLS CUI [4]
C0036601
UMLS CUI [5]
C0085271
UMLS CUI [6]
C0233520
concomitant pharmacological or psychotherapeutic treatment including but not limited to anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy; cognitive behavioral therapy; current use of other medications that would be contraindicated with antidepressant treatment, as determined by the study doctor
Description

Pharmacotherapy | Psychotherapy | Anti-Anxiety Agents | Antipsychotic Agents | Mood Stabilizers | Cognitive Therapy | Pharmaceutical Preparations Contraindicated Antidepressant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2]
C0033968
UMLS CUI [3]
C0040616
UMLS CUI [4]
C0040615
UMLS CUI [5]
C4020582
UMLS CUI [6]
C0009244
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C1444657
UMLS CUI [7,3]
C1096649
history of current substance or alcohol dependence requiring detoxification within the last 6 months
Description

Substance Dependence Requirement Detoxification

Data type

boolean

Alias
UMLS CUI [1,1]
C0038580
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0150543
currently suicidal or considered a high suicide risk
Description

Suicidal | High suicide risk

Data type

boolean

Alias
UMLS CUI [1]
C0438696
UMLS CUI [2]
C1271074
require inpatient treatment for their depression
Description

Depressive disorder Hospitalization Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C1708385
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Similar models

Eligibility Type 2 Diabetes NCT00939250

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Recurrent | Requirement Antidepressive Agents
Item
meets dsm-iv criteria for single or recurrent nonpsychotic mdd, and whom the physician deems it necessary to start on an antidepressant.
boolean
C0743081 (UMLS CUI [1])
C0743081 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0003289 (UMLS CUI [3,2])
Diabetes Mellitus, Non-Insulin-Dependent | Pharmacotherapy Non-Insulin-Dependent Diabetes Mellitus | Plasma fasting glucose measurement Quantity | Abnormal oral glucose tolerance test
Item
meets clinical criteria for type 2 diabetes as follows: (1) on pharmacological treatment for type 2 diabetes and/or (2) fasting plasma glucose > 126mg/dl on 2 separate occasions or an abnormal oral glucose tolerance test (ogtt) (2-hours post load glucose ≥ 200mg/dl).
boolean
C0011860 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
C0583513 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1847425 (UMLS CUI [4])
Hemoglobin A1c measurement
Item
hba1c > 7
boolean
C0474680 (UMLS CUI [1])
Informed Consent
Item
ability and willingness to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Hamilton rating scale for depression
Item
hamilton rating scale for depression (hrsd) score ≥ 14
boolean
C0451203 (UMLS CUI [1])
Antidepressive Agents Absent | Fluoxetine Absent | Monoamine Oxidase Inhibitors Absent
Item
not on antidepressant medication for at least 2 weeks prior to screen (or 6 weeks in the case of fluoxetine or monoamine oxidase inhibitors - maois)
boolean
C0003289 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0016365 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0026457 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Medical condition General | Medical contraindication Antidepressive Agents
Item
general medical conditions that contraindicate use of antidepressant medications
boolean
C3843040 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0003289 (UMLS CUI [2,2])
Illness Unstable | Uncontrolled hypertension | Cardiovascular Disease Symptomatic | Congestive heart failure | Angina Pectoris
Item
unstable medical illnesses, such as uncontrolled hypertension or symptomatic cardiovascular disease, such as congestive heart failure or angina
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0007222 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4])
C0002962 (UMLS CUI [5])
Psychotic Disorders | Bipolar I disorder | Bipolar II disorder | Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Anorexia | Bulimia
Item
current or past psychotic disorders including bipolar disorder (i, ii, or nos), schizophrenia, or schizoaffective disorder; anorexia; bulimia
boolean
C0033975 (UMLS CUI [1])
C0853193 (UMLS CUI [2])
C0236788 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
C0036337 (UMLS CUI [6])
C0003123 (UMLS CUI [7])
C0006370 (UMLS CUI [8])
High risk of Completion of clinical trial Unable | Hospitalization | Suicide attempt | Self Mutilation | Self-Injurious Behavior | Destructive behavior
Item
high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior
boolean
C0332167 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
C0036601 (UMLS CUI [4])
C0085271 (UMLS CUI [5])
C0233520 (UMLS CUI [6])
Pharmacotherapy | Psychotherapy | Anti-Anxiety Agents | Antipsychotic Agents | Mood Stabilizers | Cognitive Therapy | Pharmaceutical Preparations Contraindicated Antidepressant therapy
Item
concomitant pharmacological or psychotherapeutic treatment including but not limited to anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy; cognitive behavioral therapy; current use of other medications that would be contraindicated with antidepressant treatment, as determined by the study doctor
boolean
C0013216 (UMLS CUI [1])
C0033968 (UMLS CUI [2])
C0040616 (UMLS CUI [3])
C0040615 (UMLS CUI [4])
C4020582 (UMLS CUI [5])
C0009244 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C1444657 (UMLS CUI [7,2])
C1096649 (UMLS CUI [7,3])
Substance Dependence Requirement Detoxification
Item
history of current substance or alcohol dependence requiring detoxification within the last 6 months
boolean
C0038580 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0150543 (UMLS CUI [1,3])
Suicidal | High suicide risk
Item
currently suicidal or considered a high suicide risk
boolean
C0438696 (UMLS CUI [1])
C1271074 (UMLS CUI [2])
Depressive disorder Hospitalization Required
Item
require inpatient treatment for their depression
boolean
C0011581 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
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