ID

13865

Description

VA Augmentation and Switching Treatments for Improving Depression Outcomes; ODM derived from: https://clinicaltrials.gov/show/NCT01421342

Link

https://clinicaltrials.gov/show/NCT01421342

Keywords

Versions (1)
  1. 3/13/16 3/13/16 -
Uploaded on

March 13, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT01421342

English

Eligibility Major Depressive Disorder NCT01421342

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
dsm-iv diagnosis of single or recurrent, non-psychotic, major depressive disorder
Description

dsm-iv; major depressive disorder

Data type

boolean

Alias
UMLS CUI [1]
C0220952
UMLS CUI [2]
C1269683
currently taking a selective serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitor (snri) or mirtazapine for major depressive disorder
Description

selective serotonin reuptake inhibitor; serotonin-norepinephrine reuptake inhibitor; mirtazapine

Data type

boolean

Alias
UMLS CUI [1]
C0360105
UMLS CUI [2]
C3537213
UMLS CUI [3]
C0049506
need for "next-step" treatment based on documented suboptimal outcome from current antidepressant treatment for major depressive episode (at least 6 weeks treatment with a qids-c16 >= 16 or at least 8 weeks with a qids-c16 >= 11; and at least 3 weeks at a stable "optimal" dose
Description

antidepressant; therapy major depressive episode

Data type

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0154409
age: 18 years of age or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior inadequate response after an adequate treatment trial or clear cut intolerance to either of the study medications (aripiprazole or bupropion)
Description

hypersensitivity study drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0008972
current treatment with bupropion, aripiprazole or any other antipsychotic agent
Description

antipsychotic agent bupropion aripiprazole

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0085208
UMLS CUI [1,3]
C0299792
lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis not otherwise specified
Description

bipolar disorder; schizophrenia; psychosis

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033975
current diagnosis of dementia
Description

dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
current diagnosis of an eating disorder or a seizure disorder
Description

eating disorder; seizure disorder

Data type

boolean

Alias
UMLS CUI [1]
C0013473
UMLS CUI [2]
C0014544
high suicide risk currently requiring acute intervention (other than outpatient treatment of depression)
Description

High suicide risk

Data type

boolean

Alias
UMLS CUI [1]
C1271074
unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care
Description

comorbidity; hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0019993
requiring immediate hospitalization for psychiatric disorders
Description

hospitalization psychiatric disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004936
physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion criteria)
Description

drug detoxification; Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0025516
UMLS CUI [2]
C0038586
taking any concomitant medication that contraindicates any of treatment options or augmenting agents known to have an antidepressant effect
Description

concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
concurrent or recent participation (within the last 30 days) in another conflicting clinical trial with a mental health, investigational drug, or medical device intervention
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
female - pregnant or lactating or planning to become pregnant
Description

pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient was not able or willing to provide informed consent; or changed mind about participating prior to randomization
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient was not referred to the study
Description

Clinical Research

Data type

boolean

Alias
UMLS CUI [1]
C0008972
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Similar models

Eligibility Major Depressive Disorder NCT01421342

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
dsm-iv; major depressive disorder
Item
dsm-iv diagnosis of single or recurrent, non-psychotic, major depressive disorder
boolean
C0220952 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
selective serotonin reuptake inhibitor; serotonin-norepinephrine reuptake inhibitor; mirtazapine
Item
currently taking a selective serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitor (snri) or mirtazapine for major depressive disorder
boolean
C0360105 (UMLS CUI [1])
C3537213 (UMLS CUI [2])
C0049506 (UMLS CUI [3])
antidepressant; therapy major depressive episode
Item
need for "next-step" treatment based on documented suboptimal outcome from current antidepressant treatment for major depressive episode (at least 6 weeks treatment with a qids-c16 >= 16 or at least 8 weeks with a qids-c16 >= 11; and at least 3 weeks at a stable "optimal" dose
boolean
C0003289 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0154409 (UMLS CUI [2,2])
age
Item
age: 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hypersensitivity study drugs
Item
prior inadequate response after an adequate treatment trial or clear cut intolerance to either of the study medications (aripiprazole or bupropion)
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
antipsychotic agent bupropion aripiprazole
Item
current treatment with bupropion, aripiprazole or any other antipsychotic agent
boolean
C0040615 (UMLS CUI [1,1])
C0085208 (UMLS CUI [1,2])
C0299792 (UMLS CUI [1,3])
bipolar disorder; schizophrenia; psychosis
Item
lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis not otherwise specified
boolean
C0005586 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
dementia
Item
current diagnosis of dementia
boolean
C0497327 (UMLS CUI [1])
eating disorder; seizure disorder
Item
current diagnosis of an eating disorder or a seizure disorder
boolean
C0013473 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
High suicide risk
Item
high suicide risk currently requiring acute intervention (other than outpatient treatment of depression)
boolean
C1271074 (UMLS CUI [1])
comorbidity; hospitalization
Item
unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care
boolean
C0009488 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
hospitalization psychiatric disorders
Item
requiring immediate hospitalization for psychiatric disorders
boolean
C0019993 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
drug detoxification; Substance Use Disorder
Item
physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion criteria)
boolean
C0025516 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
concomitant medication
Item
taking any concomitant medication that contraindicates any of treatment options or augmenting agents known to have an antidepressant effect
boolean
C2347852 (UMLS CUI [1])
Study Subject Participation Status
Item
concurrent or recent participation (within the last 30 days) in another conflicting clinical trial with a mental health, investigational drug, or medical device intervention
boolean
C2348568 (UMLS CUI [1])
pregnancy; lactating
Item
female - pregnant or lactating or planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
informed consent
Item
patient was not able or willing to provide informed consent; or changed mind about participating prior to randomization
boolean
C0021430 (UMLS CUI [1])
Clinical Research
Item
patient was not referred to the study
boolean
C0008972 (UMLS CUI [1])
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