ID

28836

Description

Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00619619

Link

https://clinicaltrials.gov/show/NCT00619619

Keywords

Versions (1)
  1. 2/7/18 2/7/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 7, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00619619

English

Eligibility Depression NCT00619619

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00619619
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatient between 7 and 17 years of age at baseline who meet diagnostic and statistic manual of mental disorders, fourth edition, text revision criteria for major depressive disorder.
Description

Outpatients | Age | Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1269683
children's depression rating scale --revised (cdrs-r) score greater than 40 at the screening and study day -1 (baseline) visits and clinical global impressions scale--severity (cgi-s) score of greater than or equal to 4 at the screening and study day -1 (baseline) visits.
Description

Depression in children rating scale | CGI

Data type

boolean

Alias
UMLS CUI [1,1]
C3826462
UMLS CUI [1,2]
C0681889
UMLS CUI [2]
C3639708
depression of at least moderate severity with symptoms for at least 1 month before screening and that could, in the investigator`s opinion, respond to therapy with antidepressant(s) alone (without concomitant psychotherapy).
Description

Moderate depression | Severe depression | Depressive Symptoms Duration | Antidepressive Agents | Psychotherapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0588007
UMLS CUI [2]
C0588008
UMLS CUI [3,1]
C0086132
UMLS CUI [3,2]
C0449238
UMLS CUI [4]
C0003289
UMLS CUI [5,1]
C0033968
UMLS CUI [5,2]
C0332197
other inclusion criteria apply.
Description

Inclusion criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or current evidence of a medical condition known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs; history or presence of any other medical condition that might confound the study or put the study participant at greater risk during participation; known hypersensitivity to venlafaxine.
Description

Medical condition Interferes with Drug absorption | Medical condition Interferes with Drug elimination | Operative Surgical Procedure Interferes with Drug absorption | Operative Surgical Procedure Interferes with Drug elimination | Medical condition Interferes with Clinical Trial | Medical condition Study Subject Participation Status At risk Increased | Venlafaxine allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683141
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0678745
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683141
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0008976
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C1444641
UMLS CUI [6,4]
C0205217
UMLS CUI [7]
C0570764
history of suicide attempt or gesture in which the intent was suicide or serious self-harm or acute suicidality to such a degree that precaution against suicide must be exercised.
Description

Suicide attempt | Suicidal behavior | Self-Injurious Behavior | Suicidality Requirement Suicide prevention

Data type

boolean

Alias
UMLS CUI [1]
C0038663
UMLS CUI [2]
C1760428
UMLS CUI [3]
C0085271
UMLS CUI [4,1]
C3166387
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0204732
current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a diagnosis of bipolar disorder or psychotic disorder or current (within 12 months before baseline) generalized anxiety disorder, panic disorder, social anxiety disorder, or attention deficit hyperactivity disorder (adhd) if considered by the investigator to be primary (causing a higher degree of distress or impairment than mdd) or presence (within 12 months before baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, or narcissistic) as assessed during the psychiatric evaluations or history or presence of mdd with psychotic features.
Description

Psychoactive substance abuse | Psychoactive substance dependence | Alcohol abuse | Alcoholic Intoxication, Chronic | Manic episode | Post-Traumatic Stress Disorder | Obsessive-Compulsive Disorder | Bipolar Disorder | Psychotic Disorders | Generalized Anxiety Disorder | Panic Disorder | Phobia, Social | Attention deficit hyperactivity disorder Primary | Personality Disorders | Antisocial Personality Disorder | Schizotypal Personality Disorder | Histrionic Personality Disorder | Borderline Personality Disorder | Narcissistic Personality Disorder | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE

Data type

boolean

Alias
UMLS CUI [1]
C0033880
UMLS CUI [2]
C2062765
UMLS CUI [3]
C0085762
UMLS CUI [4]
C0001973
UMLS CUI [5]
C0349208
UMLS CUI [6]
C0038436
UMLS CUI [7]
C0028768
UMLS CUI [8]
C0005586
UMLS CUI [9]
C0033975
UMLS CUI [10]
C0270549
UMLS CUI [11]
C0030319
UMLS CUI [12]
C0031572
UMLS CUI [13,1]
C1263846
UMLS CUI [13,2]
C0205225
UMLS CUI [14]
C0031212
UMLS CUI [15]
C0003431
UMLS CUI [16]
C0036363
UMLS CUI [17]
C0019681
UMLS CUI [18]
C0006012
UMLS CUI [19]
C0027402
UMLS CUI [20]
C0743080
other exclusion criteria apply.
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Depression NCT00619619

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00619619
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age | Major Depressive Disorder
Item
male or female outpatient between 7 and 17 years of age at baseline who meet diagnostic and statistic manual of mental disorders, fourth edition, text revision criteria for major depressive disorder.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1269683 (UMLS CUI [3])
Depression in children rating scale | CGI
Item
children's depression rating scale --revised (cdrs-r) score greater than 40 at the screening and study day -1 (baseline) visits and clinical global impressions scale--severity (cgi-s) score of greater than or equal to 4 at the screening and study day -1 (baseline) visits.
boolean
C3826462 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
C3639708 (UMLS CUI [2])
Moderate depression | Severe depression | Depressive Symptoms Duration | Antidepressive Agents | Psychotherapy Absent
Item
depression of at least moderate severity with symptoms for at least 1 month before screening and that could, in the investigator`s opinion, respond to therapy with antidepressant(s) alone (without concomitant psychotherapy).
boolean
C0588007 (UMLS CUI [1])
C0588008 (UMLS CUI [2])
C0086132 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0003289 (UMLS CUI [4])
C0033968 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Inclusion criteria Additional
Item
other inclusion criteria apply.
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical condition Interferes with Drug absorption | Medical condition Interferes with Drug elimination | Operative Surgical Procedure Interferes with Drug absorption | Operative Surgical Procedure Interferes with Drug elimination | Medical condition Interferes with Clinical Trial | Medical condition Study Subject Participation Status At risk Increased | Venlafaxine allergy
Item
history or current evidence of a medical condition known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs; history or presence of any other medical condition that might confound the study or put the study participant at greater risk during participation; known hypersensitivity to venlafaxine.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683141 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0678745 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0008976 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0205217 (UMLS CUI [6,4])
C0570764 (UMLS CUI [7])
Suicide attempt | Suicidal behavior | Self-Injurious Behavior | Suicidality Requirement Suicide prevention
Item
history of suicide attempt or gesture in which the intent was suicide or serious self-harm or acute suicidality to such a degree that precaution against suicide must be exercised.
boolean
C0038663 (UMLS CUI [1])
C1760428 (UMLS CUI [2])
C0085271 (UMLS CUI [3])
C3166387 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0204732 (UMLS CUI [4,3])
Psychoactive substance abuse | Psychoactive substance dependence | Alcohol abuse | Alcoholic Intoxication, Chronic | Manic episode | Post-Traumatic Stress Disorder | Obsessive-Compulsive Disorder | Bipolar Disorder | Psychotic Disorders | Generalized Anxiety Disorder | Panic Disorder | Phobia, Social | Attention deficit hyperactivity disorder Primary | Personality Disorders | Antisocial Personality Disorder | Schizotypal Personality Disorder | Histrionic Personality Disorder | Borderline Personality Disorder | Narcissistic Personality Disorder | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE
Item
current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a diagnosis of bipolar disorder or psychotic disorder or current (within 12 months before baseline) generalized anxiety disorder, panic disorder, social anxiety disorder, or attention deficit hyperactivity disorder (adhd) if considered by the investigator to be primary (causing a higher degree of distress or impairment than mdd) or presence (within 12 months before baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, or narcissistic) as assessed during the psychiatric evaluations or history or presence of mdd with psychotic features.
boolean
C0033880 (UMLS CUI [1])
C2062765 (UMLS CUI [2])
C0085762 (UMLS CUI [3])
C0001973 (UMLS CUI [4])
C0349208 (UMLS CUI [5])
C0038436 (UMLS CUI [6])
C0028768 (UMLS CUI [7])
C0005586 (UMLS CUI [8])
C0033975 (UMLS CUI [9])
C0270549 (UMLS CUI [10])
C0030319 (UMLS CUI [11])
C0031572 (UMLS CUI [12])
C1263846 (UMLS CUI [13,1])
C0205225 (UMLS CUI [13,2])
C0031212 (UMLS CUI [14])
C0003431 (UMLS CUI [15])
C0036363 (UMLS CUI [16])
C0019681 (UMLS CUI [17])
C0006012 (UMLS CUI [18])
C0027402 (UMLS CUI [19])
C0743080 (UMLS CUI [20])
Exclusion Criteria Additional
Item
other exclusion criteria apply.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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