Eligibility Depressive Disorder, Major NCT00671515

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
be male or female between the ages of 18 and 70
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
dsm-iv diagnosis of major depressive disorder
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
currently depressed as confirmed by the mini-plus at the screening visit
Description

Depressed

Data type

boolean

Alias
UMLS CUI [1]
C0344315
quick inventory of depressive symptomatology-self-report(qids-sr) score > 11 at study baseline
Description

Depressive Symptoms Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C0449820
meets criteria for the metabolic syndrome as defined by the ncep atp iii criteria
Description

Metabolic Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0524620
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unstable or inadequately treated medical illness as judged by the investigator
Description

Illness Unstable | Illness Treated Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205412
severe personality disorder
Description

Personality Disorder Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0031212
UMLS CUI [1,2]
C0205082
serious suicidal risk as judged by the investigator or having a score > 2 on item 18 of the inventory of depressive symptomatology-clinician rated (ids-cr) scale
Description

At risk for suicide Serious | Depressive Symptoms Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0086132
UMLS CUI [2,2]
C0449820
known history of intolerance or hypersensitivity to pioglitazone
Description

Intolerance to Pioglitazone | Hypersensitivity Pioglitazone

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0071097
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0071097
treatment with pioglitazone in the 3 months prior to randomization
Description

Pioglitazone

Data type

boolean

Alias
UMLS CUI [1]
C0071097
currently taking an antidiabetic/glucose-lowering agent. antidiabetic agents that are prohibited include insulin, rosiglitazone, metformin, sitagliptin, sulfonylureas (e.g. glyburide, glipizide, glimepiride), non-sulfonylurea secretagogues (e.g. repaglinide, nateglinide), incretins (e.g. exenatide), and α-glucosidase inhibitors (e.g. acarbose, miglitol).
Description

Antidiabetics | Hypoglycemic Agents | Insulin | rosiglitazone | Metformin | sitagliptin | Sulfonylurea | Glyburide | Glipizide | glimepiride | Other Coding | repaglinide | nateglinide | Incretins | exenatide | alpha-Glucosidase Inhibitors | Acarbose | miglitol

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0020616
UMLS CUI [3]
C0021641
UMLS CUI [4]
C0289313
UMLS CUI [5]
C0025598
UMLS CUI [6]
C1565750
UMLS CUI [7]
C0038766
UMLS CUI [8]
C0017628
UMLS CUI [9]
C0017642
UMLS CUI [10]
C0061323
UMLS CUI [11]
C3846158
UMLS CUI [12]
C0246689
UMLS CUI [13]
C0903898
UMLS CUI [14]
C1562292
UMLS CUI [15]
C0167117
UMLS CUI [16]
C1299007
UMLS CUI [17]
C0050393
UMLS CUI [18]
C0066535
diagnosed with dementia
Description

Dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
diagnosed with heart failure
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
transaminase elevation >2.5 times the upper limit of normal
Description

Elevated serum transaminase levels

Data type

boolean

Alias
UMLS CUI [1]
C3808571
presence of renal impairment
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489

Similar models

Eligibility Depressive Disorder, Major NCT00671515

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
be male or female between the ages of 18 and 70
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
dsm-iv diagnosis of major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Depressed
Item
currently depressed as confirmed by the mini-plus at the screening visit
boolean
C0344315 (UMLS CUI [1])
Depressive Symptoms Score
Item
quick inventory of depressive symptomatology-self-report(qids-sr) score > 11 at study baseline
boolean
C0086132 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Metabolic Syndrome
Item
meets criteria for the metabolic syndrome as defined by the ncep atp iii criteria
boolean
C0524620 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Unstable | Illness Treated Inadequate
Item
unstable or inadequately treated medical illness as judged by the investigator
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Personality Disorder Severe
Item
severe personality disorder
boolean
C0031212 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
At risk for suicide Serious | Depressive Symptoms Score
Item
serious suicidal risk as judged by the investigator or having a score > 2 on item 18 of the inventory of depressive symptomatology-clinician rated (ids-cr) scale
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0086132 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Intolerance to Pioglitazone | Hypersensitivity Pioglitazone
Item
known history of intolerance or hypersensitivity to pioglitazone
boolean
C1744706 (UMLS CUI [1,1])
C0071097 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0071097 (UMLS CUI [2,2])
Pioglitazone
Item
treatment with pioglitazone in the 3 months prior to randomization
boolean
C0071097 (UMLS CUI [1])
Antidiabetics | Hypoglycemic Agents | Insulin | rosiglitazone | Metformin | sitagliptin | Sulfonylurea | Glyburide | Glipizide | glimepiride | Other Coding | repaglinide | nateglinide | Incretins | exenatide | alpha-Glucosidase Inhibitors | Acarbose | miglitol
Item
currently taking an antidiabetic/glucose-lowering agent. antidiabetic agents that are prohibited include insulin, rosiglitazone, metformin, sitagliptin, sulfonylureas (e.g. glyburide, glipizide, glimepiride), non-sulfonylurea secretagogues (e.g. repaglinide, nateglinide), incretins (e.g. exenatide), and α-glucosidase inhibitors (e.g. acarbose, miglitol).
boolean
C0935929 (UMLS CUI [1])
C0020616 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
C0289313 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
C1565750 (UMLS CUI [6])
C0038766 (UMLS CUI [7])
C0017628 (UMLS CUI [8])
C0017642 (UMLS CUI [9])
C0061323 (UMLS CUI [10])
C3846158 (UMLS CUI [11])
C0246689 (UMLS CUI [12])
C0903898 (UMLS CUI [13])
C1562292 (UMLS CUI [14])
C0167117 (UMLS CUI [15])
C1299007 (UMLS CUI [16])
C0050393 (UMLS CUI [17])
C0066535 (UMLS CUI [18])
Dementia
Item
diagnosed with dementia
boolean
C0497327 (UMLS CUI [1])
Heart failure
Item
diagnosed with heart failure
boolean
C0018801 (UMLS CUI [1])
Elevated serum transaminase levels
Item
transaminase elevation >2.5 times the upper limit of normal
boolean
C3808571 (UMLS CUI [1])
Renal Insufficiency
Item
presence of renal impairment
boolean
C1565489 (UMLS CUI [1])