ID

28831

Description

A Study of Infliximab for Treatment Resistant Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00463580

Link

https://clinicaltrials.gov/show/NCT00463580

Keywords

Versions (1)
  1. 2/7/18 2/7/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 7, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00463580

English

Eligibility Depression NCT00463580

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00463580
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or females ages 25-60. must be able to read and understand english.
Description

Age | Able to read English Language | Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0376245
2. currently meets dsm-iv criteria for a major depressive episode. (history of either unipolar major depression (depressive episodes only) or bipolar i disorder (history of manias and depressions) or bipolar ii disorder (hypomanias and depressions), current episode depressed acceptable).
Description

Single major depressive episode | Unipolar Depression | Bipolar I disorder | Mania | Depressive disorder | Bipolar II disorder | Depression with hypomania (bipolar 2)

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0041696
UMLS CUI [3]
C0853193
UMLS CUI [4]
C0338831
UMLS CUI [5]
C0011581
UMLS CUI [6]
C0236788
UMLS CUI [7]
C1852199
3. must meet criteria for "treatment resistant" depression defined by failure to respond to, or intolerance of, at least 2 treatment trials (antidepressants or ect) during the current episode.
Description

Depressive Disorder, Treatment-Resistant | Therapeutic procedure Quantity Unresponsive to Treatment | Intolerance Therapeutic procedure | Antidepressive Agents | Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C2063866
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0231199
UMLS CUI [3,2]
C0087111
UMLS CUI [4]
C0003289
UMLS CUI [5]
C0013806
4. all subjects will be fully ambulatory and in good medical health.
Description

Ambulatory | General health good

Data type

boolean

Alias
UMLS CUI [1]
C0439841
UMLS CUI [2]
C1277245
5. are required to either be antidepressant free for 2 weeks prior to study entry (4 weeks for fluoxetine secondary to long half-life) or be on a fixed psychotropic medication regimen for at least 4 weeks. subjects and their primary care providers must agree to continue their status (i.e. without antidepressant or on a fixed regimen) until the 12-week assessment is complete.
Description

Antidepressive Agents Free of | Fluoxetine Free of | On psychotropic medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0332296
UMLS CUI [2,1]
C0016365
UMLS CUI [2,2]
C0332296
UMLS CUI [3]
C3874456
6. pre-menopausal female subjects must not be pregnant and must be willing to use adequate contraception during the study period.
Description

Premenopausal state Contraceptive methods | Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. current or history of psychotic symptoms.
Description

Psychotic symptom

Data type

boolean

Alias
UMLS CUI [1]
C0871189
2. active suicidal ideation (defined as a score of ≥3 on hdrs suicide item).
Description

Feeling suicidal Hamilton depression rating scale (HDRS)

Data type

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C2021166
3. prior use of a tnf-alpha antagonist (i.e. etanercept, infliximab, adalimumab) and use of any other immunosuppressant agent (i.e. systemic corticosteroids or anti-proliferative agents such as methotrexate) within one year of study entry.
Description

Tumor necrosis factor alpha blockers | Etanercept | infliximab | adalimumab | Immunosuppressive Agents | CORTICOSTEROIDS FOR SYSTEMIC USE | Antineoplastic Agents | Methotrexate

Data type

boolean

Alias
UMLS CUI [1]
C2170827
UMLS CUI [2]
C0717758
UMLS CUI [3]
C0666743
UMLS CUI [4]
C1122087
UMLS CUI [5]
C0021081
UMLS CUI [6]
C3653708
UMLS CUI [7]
C0003392
UMLS CUI [8]
C0025677
4. current use of aspirin, non-steroidal anti-inflammatory agents (nsaids) or cox-2 inhibitors during the study. acetaminophen will be allowed.
Description

Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors | Acetaminophen allowed

Data type

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C0003211
UMLS CUI [3]
C1257954
UMLS CUI [4,1]
C0000970
UMLS CUI [4,2]
C0683607
5. history of any of the following conditions: congestive heart failure, abnormal electrocardiogram, malignancy, schizophrenia, neurological disease, auto-immune condition (e.g. rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, lupus), chronic infection (e.g. human immunodeficiency virus, hepatitis b or c), and hematologic, renal or hepatic abnormality.
Description

Congestive heart failure | Electrocardiogram abnormal | Malignant Neoplasms | Schizophrenia | Nervous system disorder | Autoimmune Diseases | Rheumatoid Arthritis | Inflammatory Bowel Diseases | Multiple Sclerosis | Lupus Erythematosus | Chronic infectious disease | HIV Infection | Hepatitis B | Hepatitis C | Abnormality Hematologic | Abnormality Kidney | Abnormality of the liver

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0522055
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0036341
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0004364
UMLS CUI [7]
C0003873
UMLS CUI [8]
C0021390
UMLS CUI [9]
C0026769
UMLS CUI [10]
C0409974
UMLS CUI [11]
C0151317
UMLS CUI [12]
C0019693
UMLS CUI [13]
C0019163
UMLS CUI [14]
C0019196
UMLS CUI [15,1]
C1704258
UMLS CUI [15,2]
C0205488
UMLS CUI [16,1]
C1704258
UMLS CUI [16,2]
C0022646
UMLS CUI [17]
C4021780
6. subjects will be excluded for a positive anti-double stranded dna antibody test.
Description

Serum double-stranded DNA antibody measurement Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C2229702
UMLS CUI [1,2]
C1514241
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Similar models

Eligibility Depression NCT00463580

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00463580
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Able to read English Language | Comprehension English Language
Item
1. males or females ages 25-60. must be able to read and understand english.
boolean
C0001779 (UMLS CUI [1])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Single major depressive episode | Unipolar Depression | Bipolar I disorder | Mania | Depressive disorder | Bipolar II disorder | Depression with hypomania (bipolar 2)
Item
2. currently meets dsm-iv criteria for a major depressive episode. (history of either unipolar major depression (depressive episodes only) or bipolar i disorder (history of manias and depressions) or bipolar ii disorder (hypomanias and depressions), current episode depressed acceptable).
boolean
C0024517 (UMLS CUI [1])
C0041696 (UMLS CUI [2])
C0853193 (UMLS CUI [3])
C0338831 (UMLS CUI [4])
C0011581 (UMLS CUI [5])
C0236788 (UMLS CUI [6])
C1852199 (UMLS CUI [7])
Depressive Disorder, Treatment-Resistant | Therapeutic procedure Quantity Unresponsive to Treatment | Intolerance Therapeutic procedure | Antidepressive Agents | Electroconvulsive Therapy
Item
3. must meet criteria for "treatment resistant" depression defined by failure to respond to, or intolerance of, at least 2 treatment trials (antidepressants or ect) during the current episode.
boolean
C2063866 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0231199 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0003289 (UMLS CUI [4])
C0013806 (UMLS CUI [5])
Ambulatory | General health good
Item
4. all subjects will be fully ambulatory and in good medical health.
boolean
C0439841 (UMLS CUI [1])
C1277245 (UMLS CUI [2])
Antidepressive Agents Free of | Fluoxetine Free of | On psychotropic medication
Item
5. are required to either be antidepressant free for 2 weeks prior to study entry (4 weeks for fluoxetine secondary to long half-life) or be on a fixed psychotropic medication regimen for at least 4 weeks. subjects and their primary care providers must agree to continue their status (i.e. without antidepressant or on a fixed regimen) until the 12-week assessment is complete.
boolean
C0003289 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0016365 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C3874456 (UMLS CUI [3])
Premenopausal state Contraceptive methods | Pregnancy Absent
Item
6. pre-menopausal female subjects must not be pregnant and must be willing to use adequate contraception during the study period.
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Psychotic symptom
Item
1. current or history of psychotic symptoms.
boolean
C0871189 (UMLS CUI [1])
Feeling suicidal Hamilton depression rating scale (HDRS)
Item
2. active suicidal ideation (defined as a score of ≥3 on hdrs suicide item).
boolean
C0424000 (UMLS CUI [1,1])
C2021166 (UMLS CUI [1,2])
Tumor necrosis factor alpha blockers | Etanercept | infliximab | adalimumab | Immunosuppressive Agents | CORTICOSTEROIDS FOR SYSTEMIC USE | Antineoplastic Agents | Methotrexate
Item
3. prior use of a tnf-alpha antagonist (i.e. etanercept, infliximab, adalimumab) and use of any other immunosuppressant agent (i.e. systemic corticosteroids or anti-proliferative agents such as methotrexate) within one year of study entry.
boolean
C2170827 (UMLS CUI [1])
C0717758 (UMLS CUI [2])
C0666743 (UMLS CUI [3])
C1122087 (UMLS CUI [4])
C0021081 (UMLS CUI [5])
C3653708 (UMLS CUI [6])
C0003392 (UMLS CUI [7])
C0025677 (UMLS CUI [8])
Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors | Acetaminophen allowed
Item
4. current use of aspirin, non-steroidal anti-inflammatory agents (nsaids) or cox-2 inhibitors during the study. acetaminophen will be allowed.
boolean
C0004057 (UMLS CUI [1])
C0003211 (UMLS CUI [2])
C1257954 (UMLS CUI [3])
C0000970 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Congestive heart failure | Electrocardiogram abnormal | Malignant Neoplasms | Schizophrenia | Nervous system disorder | Autoimmune Diseases | Rheumatoid Arthritis | Inflammatory Bowel Diseases | Multiple Sclerosis | Lupus Erythematosus | Chronic infectious disease | HIV Infection | Hepatitis B | Hepatitis C | Abnormality Hematologic | Abnormality Kidney | Abnormality of the liver
Item
5. history of any of the following conditions: congestive heart failure, abnormal electrocardiogram, malignancy, schizophrenia, neurological disease, auto-immune condition (e.g. rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, lupus), chronic infection (e.g. human immunodeficiency virus, hepatitis b or c), and hematologic, renal or hepatic abnormality.
boolean
C0018802 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0036341 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0004364 (UMLS CUI [6])
C0003873 (UMLS CUI [7])
C0021390 (UMLS CUI [8])
C0026769 (UMLS CUI [9])
C0409974 (UMLS CUI [10])
C0151317 (UMLS CUI [11])
C0019693 (UMLS CUI [12])
C0019163 (UMLS CUI [13])
C0019196 (UMLS CUI [14])
C1704258 (UMLS CUI [15,1])
C0205488 (UMLS CUI [15,2])
C1704258 (UMLS CUI [16,1])
C0022646 (UMLS CUI [16,2])
C4021780 (UMLS CUI [17])
Serum double-stranded DNA antibody measurement Positive
Item
6. subjects will be excluded for a positive anti-double stranded dna antibody test.
boolean
C2229702 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
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