ID

28920

Description

Clinical Study to Test a New Drug to Treat Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00976560

Link

https://clinicaltrials.gov/show/NCT00976560

Keywords

Versions (1)
  1. 2/16/18 2/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT00976560

English

Eligibility Depressive Disorder, Major NCT00976560

1 forms  
Criteria
Description

Criteria

adult subjects with primary diagnosis of moderate to severe mdd without psychotic features, for at least 4 weeks and one previous mdd episode
Description

Adult | Principal diagnosis Moderate Major depressive disorder Without Psychotic symptom | Principal diagnosis Severe major depression without psychotic features | Disease length | Single major depressive episode Previous

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0332137
UMLS CUI [2,2]
C1741422
UMLS CUI [2,3]
C0332288
UMLS CUI [2,4]
C0871189
UMLS CUI [3,1]
C0332137
UMLS CUI [3,2]
C0270457
UMLS CUI [4]
C0872146
UMLS CUI [5,1]
C0024517
UMLS CUI [5,2]
C0205156
males or females who agree to use protocol specified contraception if of child bearing potential
Description

Gender | Childbearing Potential Contraceptive methods Agreement

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0680240
bmi 18.5-35.0 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
normal liver function tests
Description

Liver Function Tests

Data type

boolean

Alias
UMLS CUI [1]
C0023901
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
history of liver disease or positive hepatitis b surface antigen or hepatitis c antibody in the last 3 months
Description

Liver diseases | Hepatitis B surface antigen positive | Hepatitis C antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0281863
elevated liver function tests on >2 ocassions in the last 7 months
Description

Increased liver function tests Occurrence Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0877359
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C1265611
significant medical illness, autoimmune disease or infectious disease
Description

Illness Significant | Autoimmune Disease | Communicable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0009450
pregnant or nursing females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
excessive and regular alcohol consumption
Description

Alcohol intake above recommended sensible limits Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0560219
UMLS CUI [1,2]
C0205272
history of substance abuse or dependence in past 6 months or positive urine drug screen
Description

Substance Use Disorders | Substance Dependence | Urine drug screen positive

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3]
C0743300
significant suicidal or homicidal risk
Description

At risk for suicide | At risk Homicide

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0019872
currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid
Description

Antiinflammatory therapy biological chronic | Antiinflammatory therapy pharmacological chronic | Euthyroid Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1096024
UMLS CUI [1,2]
C0205460
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C1096024
UMLS CUI [2,2]
C0205464
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C0117002
UMLS CUI [3,2]
C0332197
psychoactive drugs within 1 week or 5 half lives of randomization visit
Description

Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0033978
treatment resistant subjects
Description

Study Subject Treatment Resistant Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0871547
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Similar models

Eligibility Depressive Disorder, Major NCT00976560

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adult | Principal diagnosis Moderate Major depressive disorder Without Psychotic symptom | Principal diagnosis Severe major depression without psychotic features | Disease length | Single major depressive episode Previous
Item
adult subjects with primary diagnosis of moderate to severe mdd without psychotic features, for at least 4 weeks and one previous mdd episode
boolean
C0001675 (UMLS CUI [1])
C0332137 (UMLS CUI [2,1])
C1741422 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C0871189 (UMLS CUI [2,4])
C0332137 (UMLS CUI [3,1])
C0270457 (UMLS CUI [3,2])
C0872146 (UMLS CUI [4])
C0024517 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
Gender | Childbearing Potential Contraceptive methods Agreement
Item
males or females who agree to use protocol specified contraception if of child bearing potential
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0680240 (UMLS CUI [2,3])
Body mass index
Item
bmi 18.5-35.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Liver Function Tests
Item
normal liver function tests
boolean
C0023901 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Liver diseases | Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
history of liver disease or positive hepatitis b surface antigen or hepatitis c antibody in the last 3 months
boolean
C0023895 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0281863 (UMLS CUI [3])
Increased liver function tests Occurrence Quantity
Item
elevated liver function tests on >2 ocassions in the last 7 months
boolean
C0877359 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Illness Significant | Autoimmune Disease | Communicable Disease
Item
significant medical illness, autoimmune disease or infectious disease
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or nursing females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Alcohol intake above recommended sensible limits Regular
Item
excessive and regular alcohol consumption
boolean
C0560219 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Substance Use Disorders | Substance Dependence | Urine drug screen positive
Item
history of substance abuse or dependence in past 6 months or positive urine drug screen
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0743300 (UMLS CUI [3])
At risk for suicide | At risk Homicide
Item
significant suicidal or homicidal risk
boolean
C0563664 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0019872 (UMLS CUI [2,2])
Antiinflammatory therapy biological chronic | Antiinflammatory therapy pharmacological chronic | Euthyroid Absent
Item
currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid
boolean
C1096024 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C1096024 (UMLS CUI [2,1])
C0205464 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0117002 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Psychotropic Drugs
Item
psychoactive drugs within 1 week or 5 half lives of randomization visit
boolean
C0033978 (UMLS CUI [1])
Study Subject Treatment Resistant Disorders
Item
treatment resistant subjects
boolean
C0681850 (UMLS CUI [1,1])
C0871547 (UMLS CUI [1,2])
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