ID

30499

Description

Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00707980

Link

https://clinicaltrials.gov/show/NCT00707980

Keywords

Versions (1)
  1. 6/8/18 6/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00707980

English

Eligibility Major Depressive Disorder NCT00707980

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has completed the double blind treatment period of either study lu aa21004_304 (nct00672620) or luaa21004_305 (nct00735709) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol).
Description

Double-Blind Method Therapeutic procedure Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0013072
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205197
suffers from a major depressive episode as the primary diagnosis according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria (classification code 296.xx) at entry into the prior lu aa21004_304 or lu aa21004_305 study.
Description

Major depressive episode Principal diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0332137
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
in addition to meeting the exclusion criteria for studies lu aa21004_304 or lu aa21004_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to lu aa21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply:
Description

Exception Exposure to Lu AA21004 | Exception Exposure to Investigational New Drugs | Exception Raised intraocular pressure | Exception Angle Closure Glaucoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C3180953
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0234708
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0017605
has major depressive disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
Description

Major Depressive Disorder | Mental disorders Clinical Trial Previous | Manic Disorder | Bipolar Disorder | Schizophrenia | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205156
UMLS CUI [3]
C0024713
UMLS CUI [4]
C0005586
UMLS CUI [5]
C0036341
UMLS CUI [6]
C0033975
the participant, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the montgomery åsberg depression rating scale.
Description

At risk for suicide | Feeling suicidal Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0424000
UMLS CUI [2,2]
C4054475
the participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Description

Protocol Compliance Unlikely | Study Subject Unsuitable for other reasons

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C3844399
has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
Description

Moderate Adverse Event Investigational New Drugs | Adverse event Severe Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1513374
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0013230
has used/uses disallowed concomitant medication.
Description

Illicit medication use

Data type

boolean

Alias
UMLS CUI [1]
C0281875
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Similar models

Eligibility Major Depressive Disorder NCT00707980

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Double-Blind Method Therapeutic procedure Completed
Item
has completed the double blind treatment period of either study lu aa21004_304 (nct00672620) or luaa21004_305 (nct00735709) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol).
boolean
C0013072 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Major depressive episode Principal diagnosis
Item
suffers from a major depressive episode as the primary diagnosis according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria (classification code 296.xx) at entry into the prior lu aa21004_304 or lu aa21004_305 study.
boolean
C0024517 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exception Exposure to Lu AA21004 | Exception Exposure to Investigational New Drugs | Exception Raised intraocular pressure | Exception Angle Closure Glaucoma
Item
in addition to meeting the exclusion criteria for studies lu aa21004_304 or lu aa21004_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to lu aa21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply:
boolean
C1705847 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C3180953 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0234708 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0017605 (UMLS CUI [4,2])
Major Depressive Disorder | Mental disorders Clinical Trial Previous | Manic Disorder | Bipolar Disorder | Schizophrenia | Psychotic Disorders
Item
has major depressive disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
boolean
C1269683 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0024713 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
At risk for suicide | Feeling suicidal Montgomery-Asberg Depression Rating Scale Questionnaire
Item
the participant, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the montgomery åsberg depression rating scale.
boolean
C0563664 (UMLS CUI [1])
C0424000 (UMLS CUI [2,1])
C4054475 (UMLS CUI [2,2])
Protocol Compliance Unlikely | Study Subject Unsuitable for other reasons
Item
the participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C3844399 (UMLS CUI [2,2])
Moderate Adverse Event Investigational New Drugs | Adverse event Severe Investigational New Drugs
Item
has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
boolean
C1513374 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Illicit medication use
Item
has used/uses disallowed concomitant medication.
boolean
C0281875 (UMLS CUI [1])
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