ID

33890

Description

A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01098240

Link

https://clinicaltrials.gov/show/NCT01098240

Keywords

Versions (1)
  1. 1/5/19 1/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT01098240

English

Eligibility Major Depressive Disorder NCT01098240

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
medically healthy males or females aged 18-65 (inclusive).
Description

Healthy | Age

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0001779
patients must have a primary current diagnosis of mdd without psychotic features.
Description

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0743081
UMLS CUI [1,2]
C0205225
patients must be receiving ongoing antidepressant therapy at the time of screening. duration of the current episode of mdd must be at least 8 weeks prior to enrollment without adequate response to treatment.
Description

Antidepressant therapy | Major depressive episode Duration | Response to treatment Adequate Absent

Data type

boolean

Alias
UMLS CUI [1]
C1096649
UMLS CUI [2,1]
C0024517
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0521982
UMLS CUI [3,2]
C0205411
UMLS CUI [3,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with other psychiatric disorders.
Description

Mental disorders Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205394
patients who use tobacco products.
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
alcohol or substance abuse or dependence.
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
treatment with a monoamine oxidase inhibitor within 10 weeks of enrollment.
Description

Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0026457
pregnancy or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
clinically significant abnormalities on laboratory tests, electrocardiogram, or physical or neurologic examination.
Description

Laboratory test result abnormal | Electrocardiogram abnormal | Physical examination abnormal | Neurological examination abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0522055
UMLS CUI [3]
C0747585
UMLS CUI [4]
C1112537
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Similar models

Eligibility Major Depressive Disorder NCT01098240

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy | Age
Item
medically healthy males or females aged 18-65 (inclusive).
boolean
C3898900 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Primary
Item
patients must have a primary current diagnosis of mdd without psychotic features.
boolean
C0743081 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Antidepressant therapy | Major depressive episode Duration | Response to treatment Adequate Absent
Item
patients must be receiving ongoing antidepressant therapy at the time of screening. duration of the current episode of mdd must be at least 8 weeks prior to enrollment without adequate response to treatment.
boolean
C1096649 (UMLS CUI [1])
C0024517 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0521982 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Mental disorders Other
Item
patients with other psychiatric disorders.
boolean
C0004936 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Tobacco use
Item
patients who use tobacco products.
boolean
C0543414 (UMLS CUI [1])
Substance Use Disorders | Substance Dependence
Item
alcohol or substance abuse or dependence.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Monoamine Oxidase Inhibitors
Item
treatment with a monoamine oxidase inhibitor within 10 weeks of enrollment.
boolean
C0026457 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Laboratory test result abnormal | Electrocardiogram abnormal | Physical examination abnormal | Neurological examination abnormal
Item
clinically significant abnormalities on laboratory tests, electrocardiogram, or physical or neurologic examination.
boolean
C0438215 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C0747585 (UMLS CUI [3])
C1112537 (UMLS CUI [4])
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