ID

17081

Description

Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00429169

Link

https://clinicaltrials.gov/show/NCT00429169

Keywords

Versions (3)
  1. 8/23/16 8/23/16 -
  2. 8/23/16 8/23/16 -
  3. 8/24/16 8/24/16 -
Uploaded on

August 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00429169

English

Eligibility Depression NCT00429169

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00429169
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
currently suffering from a major depressive episode (unipolar only)
Description

Single major depressive episode Unipolar

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0443340
history of a past suicide attempt or score greater than 2 on the hamilton depression rating scale (hdrs) item #3 (suicide) at in-person screening interview. patients with suicidal plan or intent will only be enrolled as inpatients if independent inpatient treatment team agrees.
Description

Suicide attempt Past | Hamilton rating scale for depression | Planning suicide | Suicidal intent | Inpatient treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0038663
UMLS CUI [1,2]
C1444637
UMLS CUI [2]
C0451203
UMLS CUI [3]
C0424001
UMLS CUI [4]
C0582496
UMLS CUI [5]
C0019993
patients 60 years of age and older must score at least 25 on mmse at screening.
Description

Age | Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0451306
patients 60 years of age and older must have a normal ecg within the past year.
Description

Age | ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0522054
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any of the following conditions: bipolar disorder; current psychotic symptoms; bulimia or anorexia that is current or within the past year, or current purging at least twice a week for three months; already taking selective serotonin reuptake inhibitors (ssris) or bupropion for other indications (such as anxiety disorders)
Description

Bipolar Disorder | Psychotic symptom | Bulimia | Anorexia | Purging | Selective Serotonin Reuptake Inhibitors | Bupropion | Indication Anxiety Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0871189
UMLS CUI [3]
C0006370
UMLS CUI [4]
C0003123
UMLS CUI [5]
C0855227
UMLS CUI [6]
C0360105
UMLS CUI [7]
C0085208
UMLS CUI [8,1]
C3146298
UMLS CUI [8,2]
C0003469
primary disorder is an anxiety disorder (e.g., panic disorder, general anxiety disorder, obsessive compulsive disorder, social anxiety disorder), with secondary depression
Description

Anxiety Disorder Primary | Panic Disorder | Anxiety Disorders General | Obsessive-Compulsive Disorder | Phobia, Social | Depressive disorder Secondary

Data type

boolean

Alias
UMLS CUI [1,1]
C0003469
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0030319
UMLS CUI [3,1]
C0003469
UMLS CUI [3,2]
C0205246
UMLS CUI [4]
C0028768
UMLS CUI [5]
C0031572
UMLS CUI [6,1]
C0011581
UMLS CUI [6,2]
C0175668
drug or alcohol dependence within 6 months prior to study entry (current drug or alcohol abuse may be permitted if study officials determine that the abuse is of lesser importance than the major depressive episode)
Description

Substance Dependence | Substance Use Disorders | Single major depressive episode

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0024517
systolic blood pressure greater than or equal to 140 mm hg or diastolic blood pressure greater than or equal to 90 mm hg
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
significant active physical illness, particularly those that may affect the brain or serotonergic system (e.g., blood dyscrasias lymphomas, hypersplenism, endocrinopathies, kidney failure, severe chronic obstructive lung disease, autonomic neuropathies, active malignancy)
Description

physical illness Significant Affecting Brain | physical illness Significant Affecting Serotonergic Neurons System | Hematological Disease | Lymphoma | Hypersplenism | Endocrine System Diseases | Kidney Failure | Severe chronic obstructive pulmonary disease | Autonomic neuropathy | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0683323
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0006104
UMLS CUI [2,1]
C0683323
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C3178783
UMLS CUI [2,5]
C0449913
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0024299
UMLS CUI [5]
C0020532
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0035078
UMLS CUI [8]
C0730607
UMLS CUI [9]
C0259749
UMLS CUI [10]
C0006826
active medical problems
Description

Medical Problems

Data type

boolean

Alias
UMLS CUI [1]
C1254481
requires antipsychotic medication
Description

Antipsychotic Agents Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0686904
history of hypomania or mania while taking antidepressants
Description

Hypomania | Manic Disorder During Antidepressive Agents Intake

Data type

boolean

Alias
UMLS CUI [1]
C0241934
UMLS CUI [2,1]
C0024713
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0003289
UMLS CUI [2,4]
C1512806
any condition that may make the use of an ssri or bupropion medically inadvisable
Description

Condition Unfavorable Use of Selective Serotonin Reuptake Inhibitors | Condition Unfavorable Use of Bupropion

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C3640815
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C0360105
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C3640815
UMLS CUI [2,3]
C1524063
UMLS CUI [2,4]
C0085208
currently using zyban
Description

Zyban

Data type

boolean

Alias
UMLS CUI [1]
C0751626
failure to respond to adequate trials of three ssris, paroxetine, or bupropion within 2 years prior to study entry (failure to respond to therapeutic trial defined as at least 2/3 maximal daily dose [pdr] for at least 6 weeks)
Description

Selective Serotonin Reuptake Inhibitors Quantity Unresponsive to Treatment | Paroxetine Unresponsive to Treatment | Bupropion Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0360105
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C0070122
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C0085208
UMLS CUI [3,2]
C0205269
pregnant, breastfeeding, or plans to become pregnant during the course of study participation
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
currently on effective treatment, requires adjunctive antipsychotic or mood stabilizing medication, or is unlikely to respond to single agent treatment for depression
Description

Therapeutic procedure Effective | Antipsychotic Agents Adjunctive treatment Patient need for | Mood stabilizing drug Adjunctive treatment Patient need for | Antidepressive Agent Single Unresponsive to Treatment Probable

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1280519
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C3858690
UMLS CUI [2,3]
C0686904
UMLS CUI [3,1]
C1276998
UMLS CUI [3,2]
C3858690
UMLS CUI [3,3]
C0686904
UMLS CUI [4,1]
C0003289
UMLS CUI [4,2]
C0205171
UMLS CUI [4,3]
C0205269
UMLS CUI [4,4]
C0033204
patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes mri, will be excluded.
Description

presence of metallic implant | Claustrophobia Excludes Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1]
C3693688
UMLS CUI [2,1]
C0008909
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0024485
patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.
Description

Accept Unlikely Delay Start Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1272684
UMLS CUI [1,2]
C0750558
UMLS CUI [1,3]
C0205421
UMLS CUI [1,4]
C0439659
UMLS CUI [1,5]
C0087111
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Similar models

Eligibility Depression NCT00429169

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00429169
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Single major depressive episode Unipolar
Item
currently suffering from a major depressive episode (unipolar only)
boolean
C0024517 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
Suicide attempt Past | Hamilton rating scale for depression | Planning suicide | Suicidal intent | Inpatient treatment
Item
history of a past suicide attempt or score greater than 2 on the hamilton depression rating scale (hdrs) item #3 (suicide) at in-person screening interview. patients with suicidal plan or intent will only be enrolled as inpatients if independent inpatient treatment team agrees.
boolean
C0038663 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0451203 (UMLS CUI [2])
C0424001 (UMLS CUI [3])
C0582496 (UMLS CUI [4])
C0019993 (UMLS CUI [5])
Age | Mini-mental state examination
Item
patients 60 years of age and older must score at least 25 on mmse at screening.
boolean
C0001779 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
Age | ECG normal
Item
patients 60 years of age and older must have a normal ecg within the past year.
boolean
C0001779 (UMLS CUI [1])
C0522054 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Bipolar Disorder | Psychotic symptom | Bulimia | Anorexia | Purging | Selective Serotonin Reuptake Inhibitors | Bupropion | Indication Anxiety Disorders
Item
any of the following conditions: bipolar disorder; current psychotic symptoms; bulimia or anorexia that is current or within the past year, or current purging at least twice a week for three months; already taking selective serotonin reuptake inhibitors (ssris) or bupropion for other indications (such as anxiety disorders)
boolean
C0005586 (UMLS CUI [1])
C0871189 (UMLS CUI [2])
C0006370 (UMLS CUI [3])
C0003123 (UMLS CUI [4])
C0855227 (UMLS CUI [5])
C0360105 (UMLS CUI [6])
C0085208 (UMLS CUI [7])
C3146298 (UMLS CUI [8,1])
C0003469 (UMLS CUI [8,2])
Anxiety Disorder Primary | Panic Disorder | Anxiety Disorders General | Obsessive-Compulsive Disorder | Phobia, Social | Depressive disorder Secondary
Item
primary disorder is an anxiety disorder (e.g., panic disorder, general anxiety disorder, obsessive compulsive disorder, social anxiety disorder), with secondary depression
boolean
C0003469 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0030319 (UMLS CUI [2])
C0003469 (UMLS CUI [3,1])
C0205246 (UMLS CUI [3,2])
C0028768 (UMLS CUI [4])
C0031572 (UMLS CUI [5])
C0011581 (UMLS CUI [6,1])
C0175668 (UMLS CUI [6,2])
Substance Dependence | Substance Use Disorders | Single major depressive episode
Item
drug or alcohol dependence within 6 months prior to study entry (current drug or alcohol abuse may be permitted if study officials determine that the abuse is of lesser importance than the major depressive episode)
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0024517 (UMLS CUI [3])
Systolic Pressure | Diastolic blood pressure
Item
systolic blood pressure greater than or equal to 140 mm hg or diastolic blood pressure greater than or equal to 90 mm hg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
physical illness Significant Affecting Brain | physical illness Significant Affecting Serotonergic Neurons System | Hematological Disease | Lymphoma | Hypersplenism | Endocrine System Diseases | Kidney Failure | Severe chronic obstructive pulmonary disease | Autonomic neuropathy | Malignant Neoplasms
Item
significant active physical illness, particularly those that may affect the brain or serotonergic system (e.g., blood dyscrasias lymphomas, hypersplenism, endocrinopathies, kidney failure, severe chronic obstructive lung disease, autonomic neuropathies, active malignancy)
boolean
C0683323 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0006104 (UMLS CUI [1,4])
C0683323 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C3178783 (UMLS CUI [2,4])
C0449913 (UMLS CUI [2,5])
C0018939 (UMLS CUI [3])
C0024299 (UMLS CUI [4])
C0020532 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0035078 (UMLS CUI [7])
C0730607 (UMLS CUI [8])
C0259749 (UMLS CUI [9])
C0006826 (UMLS CUI [10])
Medical Problems
Item
active medical problems
boolean
C1254481 (UMLS CUI [1])
Antipsychotic Agents Patient need for
Item
requires antipsychotic medication
boolean
C0040615 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Hypomania | Manic Disorder During Antidepressive Agents Intake
Item
history of hypomania or mania while taking antidepressants
boolean
C0241934 (UMLS CUI [1])
C0024713 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0003289 (UMLS CUI [2,3])
C1512806 (UMLS CUI [2,4])
Condition Unfavorable Use of Selective Serotonin Reuptake Inhibitors | Condition Unfavorable Use of Bupropion
Item
any condition that may make the use of an ssri or bupropion medically inadvisable
boolean
C0348080 (UMLS CUI [1,1])
C3640815 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0360105 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C3640815 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
C0085208 (UMLS CUI [2,4])
Zyban
Item
currently using zyban
boolean
C0751626 (UMLS CUI [1])
Selective Serotonin Reuptake Inhibitors Quantity Unresponsive to Treatment | Paroxetine Unresponsive to Treatment | Bupropion Unresponsive to Treatment
Item
failure to respond to adequate trials of three ssris, paroxetine, or bupropion within 2 years prior to study entry (failure to respond to therapeutic trial defined as at least 2/3 maximal daily dose [pdr] for at least 6 weeks)
boolean
C0360105 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0070122 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0085208 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant, breastfeeding, or plans to become pregnant during the course of study participation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Therapeutic procedure Effective | Antipsychotic Agents Adjunctive treatment Patient need for | Mood stabilizing drug Adjunctive treatment Patient need for | Antidepressive Agent Single Unresponsive to Treatment Probable
Item
currently on effective treatment, requires adjunctive antipsychotic or mood stabilizing medication, or is unlikely to respond to single agent treatment for depression
boolean
C0087111 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2,1])
C3858690 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C1276998 (UMLS CUI [3,1])
C3858690 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
C0003289 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
C0205269 (UMLS CUI [4,3])
C0033204 (UMLS CUI [4,4])
presence of metallic implant | Claustrophobia Excludes Magnetic Resonance Imaging
Item
patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes mri, will be excluded.
boolean
C3693688 (UMLS CUI [1])
C0008909 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Accept Unlikely Delay Start Therapeutic procedure
Item
patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.
boolean
C1272684 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C0205421 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,5])
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