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])
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])