ID

36339

Beschreibung

Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT02431806

Link

https://clinicaltrials.gov/show/NCT02431806

Stichworte

Versionen (1)
  1. 04.05.19 04.05.19 -
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See clinicaltrials.gov

Hochgeladen am

4. Mai 2019

DOI

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Eligibility Major Depressive Disorder (MDD) NCT02431806

Englisch

Eligibility Major Depressive Disorder (MDD) NCT02431806

1 Formulare  
Criteria
Beschreibung

Criteria

1. male or female outpatients;12-17 years of age
Beschreibung

Outpatients | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
2. meet diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for major depressive disorder (mdd) , confirmed by kiddie schedule for affective disorders and schizophrenia for school-age children--present and lifetime (k-sads-pl)
Beschreibung

Major Depressive Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
3. score ≥ 40 on the children's depression rating scale-revised (cdrs-r) at visits 1 and 2
Beschreibung

Depression in children Rating scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3826462
UMLS CUI [1,2]
C0681889
4. clinical global impressions-severity (cgi-s) score ≥ 4 at visits 1 and 2
Beschreibung

CGI - Severity of Illness

Datentyp

boolean

Alias
UMLS CUI [1]
C3639887
5. reliable caregiver
Beschreibung

Caregiver reliable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C3858758
6. physical examination, vital signs, clinical laboratory tests, and ecg normal or not clinically significant
Beschreibung

Physical examination normal | Normal vital signs | Laboratory test normal | ECG normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0855737
UMLS CUI [2]
C0277803
UMLS CUI [3]
C1096215
UMLS CUI [4]
C0522054
key psychiatric exclusion criteria:
Beschreibung

Exclusion Criteria Psychiatric Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205487
UMLS CUI [1,3]
C1542147
1. dsm-iv-tr-based diagnosis of an axis i disorder other than mdd that is the primary focus of treatment
Beschreibung

Primary therapy Axis I diagnosis | Exception Major Depressive Disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1269683
2. mental retardation or amnestic or other cognitive disorders
Beschreibung

Mental Retardation | Amnestic Disorder | Cognition Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2]
C0002625
UMLS CUI [3]
C0009241
3) significant suicide risk:
Beschreibung

At risk for suicide

Datentyp

boolean

Alias
UMLS CUI [1]
C0563664
suicide attempt within the past year or
Beschreibung

Suicide attempt

Datentyp

boolean

Alias
UMLS CUI [1]
C0038663
investigator judgment (based on psychiatric interview and c-ssrs)
Beschreibung

Investigator Judgment Columbia suicide severity rating scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C3888485
key treatment-related exclusion criteria:
Beschreibung

Exclusion Criteria Main Relationship Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0087111
1. allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitors (snri)
Beschreibung

Hypersensitivity Levomilnacipran | Intolerance to Levomilnacipran | Hypersensitivity Milnacipran | Intolerance to Milnacipran | Fluoxetine allergy | Intolerance to Fluoxetine | Selective serotonin re-uptake inhibitor allergy | Intolerance to Selective Serotonin Reuptake Inhibitors | Hypersensitivity Serotonin and Norepinephrine Reuptake Inhibitor | Intolerance to Serotonin and Norepinephrine Reuptake Inhibitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3541367
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C3541367
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1533126
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C1533126
UMLS CUI [5]
C0570770
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0016365
UMLS CUI [7]
C0570765
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0360105
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C3537213
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C3537213
2. use of prohibited concomitant medication that cannot be discontinued
Beschreibung

Illicit medication use | Illicit medication use Discontinue Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2,1]
C0281875
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1272705
other key medical exclusion criteria:
Beschreibung

Exclusion Criteria Medical Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C1542147
1. any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect patient safety
Beschreibung

Medical condition Interferes with Completion of clinical trial | Medical condition Interferes with Interpretation Research results | Medical condition Affecting Patient safety

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0683954
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1113679
2. liver enzyme tests (aspartate aminotransferase) ast and/or alanine aminotransferase (alt) > 2x the upper limit of normal (uln)
Beschreibung

Liver enzyme test | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0428321
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
3. clinically significant cardiovascular disorders
Beschreibung

Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
4. seizure disorder or risk of seizure
Beschreibung

Epilepsy | At risk Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0014544
5. drug or alcohol abuse or dependence (within the past year)
Beschreibung

Substance Use Disorders | Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
6. positive urine drug screen or blood alcohol
Beschreibung

Urine drug screen positive | Blood alcohol test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0948726
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Ähnliche Modelle

Eligibility Major Depressive Disorder (MDD) NCT02431806

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Outpatients | Age
Item
1. male or female outpatients;12-17 years of age
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Major Depressive Disorder
Item
2. meet diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for major depressive disorder (mdd) , confirmed by kiddie schedule for affective disorders and schizophrenia for school-age children--present and lifetime (k-sads-pl)
boolean
C1269683 (UMLS CUI [1])
Depression in children Rating scale
Item
3. score ≥ 40 on the children's depression rating scale-revised (cdrs-r) at visits 1 and 2
boolean
C3826462 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
CGI - Severity of Illness
Item
4. clinical global impressions-severity (cgi-s) score ≥ 4 at visits 1 and 2
boolean
C3639887 (UMLS CUI [1])
Caregiver reliable
Item
5. reliable caregiver
boolean
C0085537 (UMLS CUI [1,1])
C3858758 (UMLS CUI [1,2])
Physical examination normal | Normal vital signs | Laboratory test normal | ECG normal
Item
6. physical examination, vital signs, clinical laboratory tests, and ecg normal or not clinically significant
boolean
C0855737 (UMLS CUI [1])
C0277803 (UMLS CUI [2])
C1096215 (UMLS CUI [3])
C0522054 (UMLS CUI [4])
Exclusion Criteria Psychiatric Main
Item
key psychiatric exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Primary therapy Axis I diagnosis | Exception Major Depressive Disorder
Item
1. dsm-iv-tr-based diagnosis of an axis i disorder other than mdd that is the primary focus of treatment
boolean
C1708063 (UMLS CUI [1,1])
C0270287 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
Mental Retardation | Amnestic Disorder | Cognition Disorders
Item
2. mental retardation or amnestic or other cognitive disorders
boolean
C0025362 (UMLS CUI [1])
C0002625 (UMLS CUI [2])
C0009241 (UMLS CUI [3])
At risk for suicide
Item
3) significant suicide risk:
boolean
C0563664 (UMLS CUI [1])
Suicide attempt
Item
suicide attempt within the past year or
boolean
C0038663 (UMLS CUI [1])
Investigator Judgment Columbia suicide severity rating scale
Item
investigator judgment (based on psychiatric interview and c-ssrs)
boolean
C0035173 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C3888485 (UMLS CUI [1,3])
Exclusion Criteria Main Relationship Treatment
Item
key treatment-related exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Hypersensitivity Levomilnacipran | Intolerance to Levomilnacipran | Hypersensitivity Milnacipran | Intolerance to Milnacipran | Fluoxetine allergy | Intolerance to Fluoxetine | Selective serotonin re-uptake inhibitor allergy | Intolerance to Selective Serotonin Reuptake Inhibitors | Hypersensitivity Serotonin and Norepinephrine Reuptake Inhibitor | Intolerance to Serotonin and Norepinephrine Reuptake Inhibitor
Item
1. allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitors (snri)
boolean
C0020517 (UMLS CUI [1,1])
C3541367 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C3541367 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1533126 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C1533126 (UMLS CUI [4,2])
C0570770 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0016365 (UMLS CUI [6,2])
C0570765 (UMLS CUI [7])
C1744706 (UMLS CUI [8,1])
C0360105 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C3537213 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C3537213 (UMLS CUI [10,2])
Illicit medication use | Illicit medication use Discontinue Unsuccessful
Item
2. use of prohibited concomitant medication that cannot be discontinued
boolean
C0281875 (UMLS CUI [1])
C0281875 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Exclusion Criteria Medical Main
Item
other key medical exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Medical condition Interferes with Completion of clinical trial | Medical condition Interferes with Interpretation Research results | Medical condition Affecting Patient safety
Item
1. any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect patient safety
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
Liver enzyme test | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
2. liver enzyme tests (aspartate aminotransferase) ast and/or alanine aminotransferase (alt) > 2x the upper limit of normal (uln)
boolean
C0428321 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Cardiovascular Disease
Item
3. clinically significant cardiovascular disorders
boolean
C0007222 (UMLS CUI [1])
Epilepsy | At risk Epilepsy
Item
4. seizure disorder or risk of seizure
boolean
C0014544 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0014544 (UMLS CUI [2,2])
Substance Use Disorders | Substance Dependence
Item
5. drug or alcohol abuse or dependence (within the past year)
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Urine drug screen positive | Blood alcohol test positive
Item
6. positive urine drug screen or blood alcohol
boolean
C0743300 (UMLS CUI [1])
C0948726 (UMLS CUI [2])
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