ID

43937

Description

Modafinil for Atypical Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00215176

Link

https://clinicaltrials.gov/show/NCT00215176

Keywords

Versions (2)
  1. 7/4/16 7/4/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Atypical Depression NCT00215176

English

Eligibility Atypical Depression NCT00215176

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults 18-65 years of age
Description

Age | Adult

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0001675
dsm-iv criteria for major depressive episode with atypical features as assessed by the atypical depression diagnostic scale
Description

major depressive episode | Symptoms Atypical

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0205182
minimum score of 18 on the hamilton depression scale (29-item version) at baseline
Description

Hamilton rating scale for depression | Score Minimum

Data type

boolean

Alias
UMLS CUI [1]
C0451203
UMLS CUI [2,1]
C0449820
UMLS CUI [2,2]
C1524031
baseline clinical global impressions severity score of 4 or more
Description

Clinical Global Impression Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3639708
written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
negative serum pregnancy test for women of childbearing potential
Description

Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any current primary dsm-iv axis i disorder other than depression
Description

Axis I diagnosis | Depressive disorder

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0011581
history of dsm-iv diagnosis of bipolar i disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
Description

Bipolar I disorder | Schizophrenia | Psychotic Disorders | Mental Retardation | Pervasive Development Disorder | Cognition Disorders Due to medical condition General

Data type

boolean

Alias
UMLS CUI [1]
C0853193
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0025362
UMLS CUI [5]
C0524528
UMLS CUI [6,1]
C0009241
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C3843040
UMLS CUI [6,4]
C0205246
history of substance abuse or dependence within the last 3 months
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
suicide risk or serious suicide attempt with the last year
Description

At risk for suicide | Suicide attempt Serious

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0038663
UMLS CUI [2,2]
C0205404
clinically significant medical condition or laboratory or ekg abnormality
Description

medical condition Clinical Significance | Laboratory test result abnormal | ECG abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0438215
UMLS CUI [3]
C0522055
history of non-response to three prior adequate trials of antidepressants
Description

Clinical Trials | Antidepressive Agents Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1]
C0008976
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0205269
women of childbearing potential who are unwilling to practice an acceptable method of contraception
Description

Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
history of hypersensitivity to modafinil
Description

Hypersensitivity modafinil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0066677
use of an investigational medication within the last 28 days
Description

Investigational New Drugs Use

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1524063
use of antidepressant medication with 28 days of screening
Description

Antidepressive Agents Use

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1524063
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Similar models

Eligibility Atypical Depression NCT00215176

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Adult
Item
adults 18-65 years of age
boolean
C0001779 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
major depressive episode | Symptoms Atypical
Item
dsm-iv criteria for major depressive episode with atypical features as assessed by the atypical depression diagnostic scale
boolean
C0024517 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0205182 (UMLS CUI [2,2])
Hamilton rating scale for depression | Score Minimum
Item
minimum score of 18 on the hamilton depression scale (29-item version) at baseline
boolean
C0451203 (UMLS CUI [1])
C0449820 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
Clinical Global Impression Questionnaire
Item
baseline clinical global impressions severity score of 4 or more
boolean
C3639708 (UMLS CUI [1])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
negative serum pregnancy test for women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Depressive disorder
Item
any current primary dsm-iv axis i disorder other than depression
boolean
C0270287 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
Bipolar I disorder | Schizophrenia | Psychotic Disorders | Mental Retardation | Pervasive Development Disorder | Cognition Disorders Due to medical condition General
Item
history of dsm-iv diagnosis of bipolar i disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
boolean
C0853193 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0025362 (UMLS CUI [4])
C0524528 (UMLS CUI [5])
C0009241 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C3843040 (UMLS CUI [6,3])
C0205246 (UMLS CUI [6,4])
Substance Use Disorders | Substance Dependence
Item
history of substance abuse or dependence within the last 3 months
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
At risk for suicide | Suicide attempt Serious
Item
suicide risk or serious suicide attempt with the last year
boolean
C0563664 (UMLS CUI [1])
C0038663 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
medical condition Clinical Significance | Laboratory test result abnormal | ECG abnormality
Item
clinically significant medical condition or laboratory or ekg abnormality
boolean
C3843040 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
Clinical Trials | Antidepressive Agents Unresponsive to Treatment
Item
history of non-response to three prior adequate trials of antidepressants
boolean
C0008976 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods Unwilling
Item
women of childbearing potential who are unwilling to practice an acceptable method of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Hypersensitivity modafinil
Item
history of hypersensitivity to modafinil
boolean
C0020517 (UMLS CUI [1,1])
C0066677 (UMLS CUI [1,2])
Investigational New Drugs Use
Item
use of an investigational medication within the last 28 days
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Antidepressive Agents Use
Item
use of antidepressant medication with 28 days of screening
boolean
C0003289 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
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