ID

16910

Description

Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00608543

Link

https://clinicaltrials.gov/show/NCT00608543

Keywords

Versions (1)
  1. 8/13/16 8/13/16 -
Uploaded on

August 13, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00608543

English

Eligibility Major Depressive Disorder NCT00608543

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
primary diagnosis of major depressive disorder (mdd)
Description

Major depressive disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
completion of at least 8-12 weeks (and no longer than 6 months) of treatment with escitalopram, citalopram, or sertraline, with at least 6 weeks at an adequate dose (i.e., 20 mg escitalopram; 40 mg citalopram; 150 mg sertraline)
Description

Antidepressant therapy

Data type

boolean

Alias
UMLS CUI [1]
C1099456
UMLS CUI [2]
C0008845
UMLS CUI [3]
C0074393
hamilton rating scale for depression, 17-item (hrsd17) score less than or equal to 14 and/or clinical global impression - severity (cgi-s) score less than or equal to 3
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
self-reported difficulties with cognition and/or concentration, and an inventory for depressive symptomatology clinician-rated, 30-item (ids-c30) item #16 (concentration and decision making) score less than or equal to 2
Description

Difficulties with cognition and/or concentration

Data type

boolean

Alias
UMLS CUI [1]
C0009240
UMLS CUI [2]
C0424098
ability to read and write in english (required because instructions for cognitive testing and several questionnaires are available only in english)
Description

Language

Data type

boolean

Alias
UMLS CUI [1]
C1145677
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of untreated or unstable comorbid medical condition based on physician information or evidence at examination, such as hypertension, diabetes, hypothyroidism.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
presence of known cardiovascular disease or seizure disorder.
Description

Cardiovascular disease or seizure disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0014544
presence of other primary psychiatric disorders or conditions (including depression due to medical conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (i, ii, or not otherwise specified [nos]), schizophrenia, schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse or dependence within the last 6 months)
Description

Other primary psychiatric disorders or conditions

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0520618
UMLS CUI [3]
C0438696
UMLS CUI [4]
C0033975
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0036341
UMLS CUI [7]
C0036337
UMLS CUI [8]
C0003125
UMLS CUI [9]
C0006370
UMLS CUI [10]
C0028768
presence of organic brain injury or dementia, based on a cutoff score of < 20 on the mini mental status examination (mmse).
Description

organic brain injury or dementia

Data type

boolean

Alias
UMLS CUI [1]
C0270611
UMLS CUI [2,1]
C0497327
UMLS CUI [2,2]
C0451306
concomitant pharmacological or psychotherapeutic treatment (in addition to one ssri as described in inclusion criteria) including but not limited to anxiolytics, neuroleptics, mood stabilizers
Description

Concomitant pharmacological or psychotherapeutic treatment

Data type

boolean

Alias
UMLS CUI [1]
C1707479
Hospitalization for mental illness within the past year.
Description

Hospitalization for mental illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004936
for women, currently pregnant or planning to become pregnant in the next year.
Description

pregnant or planning to become pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C2081645
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Similar models

Eligibility Major Depressive Disorder NCT00608543

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-65
boolean
C0001779 (UMLS CUI [1])
Major depressive disorder
Item
primary diagnosis of major depressive disorder (mdd)
boolean
C1269683 (UMLS CUI [1])
Antidepressant therapy
Item
completion of at least 8-12 weeks (and no longer than 6 months) of treatment with escitalopram, citalopram, or sertraline, with at least 6 weeks at an adequate dose (i.e., 20 mg escitalopram; 40 mg citalopram; 150 mg sertraline)
boolean
C1099456 (UMLS CUI [1])
C0008845 (UMLS CUI [2])
C0074393 (UMLS CUI [3])
Hamilton rating scale for depression
Item
hamilton rating scale for depression, 17-item (hrsd17) score less than or equal to 14 and/or clinical global impression - severity (cgi-s) score less than or equal to 3
boolean
C0451203 (UMLS CUI [1])
Difficulties with cognition and/or concentration
Item
self-reported difficulties with cognition and/or concentration, and an inventory for depressive symptomatology clinician-rated, 30-item (ids-c30) item #16 (concentration and decision making) score less than or equal to 2
boolean
C0009240 (UMLS CUI [1])
C0424098 (UMLS CUI [2])
Language
Item
ability to read and write in english (required because instructions for cognitive testing and several questionnaires are available only in english)
boolean
C1145677 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity
Item
presence of untreated or unstable comorbid medical condition based on physician information or evidence at examination, such as hypertension, diabetes, hypothyroidism.
boolean
C0009488 (UMLS CUI [1])
Cardiovascular disease or seizure disorder
Item
presence of known cardiovascular disease or seizure disorder.
boolean
C0007222 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Other primary psychiatric disorders or conditions
Item
presence of other primary psychiatric disorders or conditions (including depression due to medical conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (i, ii, or not otherwise specified [nos]), schizophrenia, schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse or dependence within the last 6 months)
boolean
C0004936 (UMLS CUI [1])
C0520618 (UMLS CUI [2])
C0438696 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0036341 (UMLS CUI [6])
C0036337 (UMLS CUI [7])
C0003125 (UMLS CUI [8])
C0006370 (UMLS CUI [9])
C0028768 (UMLS CUI [10])
organic brain injury or dementia
Item
presence of organic brain injury or dementia, based on a cutoff score of < 20 on the mini mental status examination (mmse).
boolean
C0270611 (UMLS CUI [1])
C0497327 (UMLS CUI [2,1])
C0451306 (UMLS CUI [2,2])
Concomitant pharmacological or psychotherapeutic treatment
Item
concomitant pharmacological or psychotherapeutic treatment (in addition to one ssri as described in inclusion criteria) including but not limited to anxiolytics, neuroleptics, mood stabilizers
boolean
C1707479 (UMLS CUI [1])
Hospitalization for mental illness
Item
Hospitalization for mental illness within the past year.
boolean
C0019993 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
pregnant or planning to become pregnant
Item
for women, currently pregnant or planning to become pregnant in the next year.
boolean
C0032961 (UMLS CUI [1])
C2081645 (UMLS CUI [2])
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