ID

28918

Beschreibung

Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00671515

Link

https://clinicaltrials.gov/show/NCT00671515

Stichworte

Versionen (1)
  1. 15.02.18 15.02.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

15. Februar 2018

DOI

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Eligibility Depressive Disorder, Major NCT00671515

Englisch

Eligibility Depressive Disorder, Major NCT00671515

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Major Depressive Disorder

Datentyp

boolean

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

Depressed

Datentyp

boolean

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

Depressive Symptoms Score

Datentyp

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
Beschreibung

Metabolic Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0524620
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Illness Unstable | Illness Treated Inadequate

Datentyp

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
Beschreibung

Personality Disorder Severe

Datentyp

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
Beschreibung

At risk for suicide Serious | Depressive Symptoms Score

Datentyp

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
Beschreibung

Intolerance to Pioglitazone | Hypersensitivity Pioglitazone

Datentyp

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
Beschreibung

Pioglitazone

Datentyp

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).
Beschreibung

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

Datentyp

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
Beschreibung

Dementia

Datentyp

boolean

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

Heart failure

Datentyp

boolean

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

Elevated serum transaminase levels

Datentyp

boolean

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

Renal Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
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Ähnliche Modelle

Eligibility Depressive Disorder, Major NCT00671515

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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