Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years, With Major Depressive Disorder (MDD)
2 other identifiers
interventional
784
18 countries
119
Brief Summary
Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2016
Typical duration for phase_3
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2019
CompletedResults Posted
Study results publicly available
August 19, 2020
CompletedAugust 19, 2020
August 1, 2020
3.2 years
March 11, 2016
May 26, 2020
August 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).
From Randomization to Week 8
Secondary Outcomes (27)
Change in CDRS-R Total Score During Treatment (at Week 2)
At week 2
Change in CDRS-R Total Score During Treatment (at Week 4)
At week 4
Change in CDRS-R Total Score During Treatment (at Week 6)
At week 6
Change in CDRS-R Mood Score
From randomization to Week 8
Change in CDRS-R Somatic Score
From Randomization to Week 8
- +22 more secondary outcomes
Study Arms (4)
Vortioxetine 10 mg/day
EXPERIMENTALVortioxetine 20 mg/day
EXPERIMENTALFluoxetine 20 mg/day,
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed
Eligibility Criteria
You may qualify if:
- The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who turn 18 years during the study will be allowed to continue in the study).
- The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.
- The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45 at the Screening Visit and at the Baseline.
- The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at the Screening Visit and at the Baseline
- The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
You may not qualify if:
- The patient has participated in a clinical study \<30 days prior to the Screening Visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
- Takedacollaborator
Study Sites (124)
US1369
Dothan, Alabama, United States
US1333
Tucson, Arizona, United States
US1310
Little Rock, Arkansas, United States
US1062
Costa Mesa, California, United States
US1387
Downey, California, United States
US1114
Escondido, California, United States
US1118
Glendale, California, United States
US1123
Imperial, California, United States
US1160 Renew Behavioral Health, Inc.
Long Beach, California, United States
US1368
Orange, California, United States
US1370
Panorama City, California, United States
US1351
Wildomar, California, United States
US1133
Washington D.C., District of Columbia, United States
US1217
Gainesville, Florida, United States
US1229
Orange City, Florida, United States
US1009
Atlanta, Georgia, United States
US1313
Marietta, Georgia, United States
US1311
Naperville, Illinois, United States
US1315
Naperville, Illinois, United States
US1103
Oak Brook, Illinois, United States
US1386
Wichita, Kansas, United States
US1261
Lake Charles, Louisiana, United States
US1015
Baltimore, Maryland, United States
US1385 Ericksen Research And Development
Clinton, Mississippi, United States
US1064
Creve Coeur, Missouri, United States
US1314
O'Fallon, Missouri, United States
US1266
Saint Charles, Missouri, United States
US1312
Berlin, New Jersey, United States
US1222
Princeton, New Jersey, United States
US1317
New York, New York, United States
US1171
Rochester, New York, United States
US1190
Staten Island, New York, United States
US1051
Cincinnati, Ohio, United States
US1054
Cleveland, Ohio, United States
US1334
Middleburg Heights, Ohio, United States
US1323
Oklahoma City, Oklahoma, United States
US1329
Oklahoma City, Oklahoma, United States
US1328
Austin, Texas, United States
US1320
Plano, Texas, United States
US1162
San Antonio, Texas, United States
US1308
Orem, Utah, United States
US1309
Richmond, Virginia, United States
BG1023
Targovishte, Bulgaria
BG1025
Varna, Bulgaria
CA1036 University of Calgary
Calgary, Canada
CA1038
Toronto, Canada
CO1003
Barranquilla, Colombia
CO1001
Bello, Colombia
CO1004
Bogotá, Colombia
CO1002
Pereira, Colombia
EE1007
Tallinn, Estonia
EE1015
Viljandi, Estonia
FR1041
Douai, France
FR1017
Élancourt, France
FR1009
Nantes, France
DE1078
Freiburg im Breisgau, Germany
DE1034
Mainz, Germany
DE1077
Mannheim, Germany
DE1081
Maulbronn, Germany
DE1076
Tübingen, Germany
HU1023
Budapest, Hungary
HU1020
Gyula, Hungary
IT1075
Cagliari, Italy
IT1073
Genova, Italy
IT1029
Messina, Italy
IT1068
Napoli, Italy
IT1074
Padua, Italy
IT1070
Pisa, Italy
IT1072 Osppedale Bambin gesu
Rome, Italy
LV1002
Jelgava, Latvia
LV1008
Liepāja, Latvia
LV1009
Riga, Latvia
LV1007
Sigulda, Latvia
MX1014
Culiacán, Mexico
MX1011
Guadalajara, Mexico
MX1013
Guadalajara, Mexico
MX1022
Guadalajara, Mexico
MX1023
Mazatlán, Mexico
MX1003
Mexico City, Mexico
MX1001
Nuevo León, Mexico
PL1002
Bialystok, Poland
PL1050
Gdansk, Poland
PL1068
Kielce, Poland
PL1057
Lublin, Poland
PL1052
Poznan, Poland
PL1054
Wąbrzeźno, Poland
PL1051
Wroclaw, Poland
RU1009
Arkhangelsk, Russia
RU1059
Engel's, Russia
RU1046
Krasnodar, Russia
RU1011
Lipetsk, Russia
RU1004
Nizhny Novgorod, Russia
RU1010
Novosibirsk, Russia
RU1012
Rostov-on-Don, Russia
RU1044
Rostov-on-Don, Russia
RU1030
Saint Petersburg, Russia
RU1013
Saratov, Russia
RU1038
Saratov, Russia
RU1057
Tomsk, Russia
RU1048
Tonnel’nyy, Russia
RU1016
Yekaterinburg, Russia
RS1006 Clinic of Neurology and Psychiatry for Children and Adolescents
Belgrade, Serbia
RS1010
Belgrade, Serbia
RS1011
Kragujevac, Serbia
RS1003
Niš, Serbia
RS1007
Novi Sad, Serbia
ZA1019
Cape Town, South Africa
ZA1022
Randburg, South Africa
ZA1023
Sandton, South Africa
KR1035
Cheonan, South Korea
UA1037
Gyeongsang, South Korea
KR1032
Seoul, South Korea
KR1038
Seoul, South Korea
ES1041
Alcorcón, Spain
ES1044
Madrid, Spain
ES1043
Pamplona, Spain
ES1018 Hospital de Sabadell
Sabadell, Spain
ES1040
Torremolinos, Spain
UA1002
Kyiv, Ukraine
UA1019
Odesa, Ukraine
UA1001
Poltava, Ukraine
UA1004
Ternopil, Ukraine
GB1051
Glasgow, United Kingdom
GB1047
Liverpool, United Kingdom
Related Publications (1)
Findling RL, DelBello MP, Zuddas A, Emslie GJ, Ettrup A, Petersen ML, Schmidt SN, Rosen M. Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study. J Am Acad Child Adolesc Psychiatry. 2022 Sep;61(9):1106-1118.e2. doi: 10.1016/j.jaac.2022.01.004. Epub 2022 Jan 13.
PMID: 35033635DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Email contact via
- Organization
- H. Lundbeck A/S
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2016
First Posted
March 16, 2016
Study Start
May 1, 2016
Primary Completion
July 2, 2019
Study Completion
July 30, 2019
Last Updated
August 19, 2020
Results First Posted
August 19, 2020
Record last verified: 2020-08