Clinical trial NCT02709746: Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: paediatric patients
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Takeda
First posted: 2016-03-16
Enrollment: 784
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* The patient has participated in a clinical study \<30 days prior to the Screening Visit.

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment
timeFrame: From Randomization to Week 8
Secondary outcomes:
measure: Change in CDRS-R Total Score During Treatment (at Week 2)
timeFrame: At week 2
measure: Change in CDRS-R Total Score During Treatment (at Week 4)
timeFrame: At week 4
measure: Change in CDRS-R Total Score During Treatment (at Week 6)
timeFrame: At week 6
measure: Change in CDRS-R Mood Score
timeFrame: From randomization to Week 8
measure: Change in CDRS-R Somatic Score
timeFrame: From Randomization to Week 8
measure: Change in CDRS-R Subjective Score
timeFrame: From Randomization to Week 8
measure: Change in CDRS-R Behaviour Score
timeFrame: From Randomization to Week 8
measure: CDRS-R Response
timeFrame: From Randomization to Week 8
measure: CDRS-R Remission
timeFrame: From Randomization to Week 8
measure: Change in General Behaviour Inventory (GBI) Depression Sub Scale Score Assessed by the Parents
timeFrame: From randomization to week 8
measure: Change General Behaviour Inventory (GBI) Depression Subscale Score Assessed by the Child
timeFrame: From randomization to Week 8
measure: Parent Global Assessment-Global Improvement (PGA) Score
timeFrame: From Randomization to Week 8
measure: Change in Symbol Digit Modalities Test (SDMT)
timeFrame: From Randomization to Week 8
measure: Change in Clinical Global Impression Severity of Illness (CGI-S) Score
timeFrame: From Randomization to Week 8
measure: Clinical Global Impression - Global Improvement (CGI-I) Score
timeFrame: From Randomization to Week 8
measure: CGI-S Remission
timeFrame: From Randomization to Week 8
measure: Change in Children's Global Assessment Scale (CGAS) Score
timeFrame: From Randomization to Week 8
measure: Change in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score
timeFrame: From Randomization to Week 8
measure: Change in PedsQL VAS: Sad or Blue (Sadness) Score
timeFrame: From Randomization to Week 8
measure: Change in PedsQL VAS: Angry Score
timeFrame: From Randomization to Week 8
measure: Change in PedsQL VAS: Worry Score
timeFrame: From Randomization to Week 8
measure: Change in PedsQL VAS: Tired (Fatigue) Score
timeFrame: From Randomization to week 8
measure: Change in PedsQL VAS: Pain or Hurt Score
timeFrame: From Randomization to Week 8
measure: Change in PedsQL VAS Total Average Score
timeFrame: From Randomization to week 8
measure: Change in PedsQL Emotional Distress Summary Average Score
timeFrame: From Randomization to week 8
measure: Change in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Scores
timeFrame: From Randomization to Week 8
measure: Change in PQ-LES-Q Overall Score
timeFrame: From Randomization to Week 8
Other outcomes:
Locations:
city: Dothan
country: United States
facility: US1369
state: Alabama
city: Tucson
country: United States
facility: US1333
state: Arizona
city: Little Rock
country: United States
facility: US1310
state: Arkansas
city: Costa Mesa
country: United States
facility: US1062
state: California
city: Downey
country: United States
facility: US1387
state: California
city: Escondido
country: United States
facility: US1114
state: California
city: Glendale
country: United States
facility: US1118
state: California
city: Imperial
country: United States
facility: US1123
state: California
city: Long Beach
country: United States
facility: US1160 Renew Behavioral Health, Inc.
state: California
city: Orange
country: United States
facility: US1368
state: California
city: Panorama City
country: United States
facility: US1370
state: California
city: Wildomar
country: United States
facility: US1351
state: California
city: Washington
country: United States
facility: US1133
state: District of Columbia
city: Gainesville
country: United States
facility: US1217
state: Florida
city: Orange City
country: United States
facility: US1229
state: Florida
city: Atlanta
country: United States
facility: US1009
state: Georgia
city: Marietta
country: United States
facility: US1313
state: Georgia
city: Naperville
country: United States
facility: US1311
state: Illinois
city: Naperville
country: United States
facility: US1315
state: Illinois
city: Oak Brook
country: United States
facility: US1103
state: Illinois
city: Wichita
country: United States
facility: US1386
state: Kansas
city: Lake Charles
country: United States
facility: US1261
state: Louisiana
city: Baltimore
country: United States
facility: US1015
state: Maryland
city: Clinton
country: United States
facility: US1385 Ericksen Research And Development
state: Mississippi
city: Creve Coeur
country: United States
facility: US1064
state: Missouri
city: O'Fallon
country: United States
facility: US1314
state: Missouri
city: Saint Charles
country: United States
facility: US1266
state: Missouri
city: Berlin
country: United States
facility: US1312
state: New Jersey
city: Princeton
country: United States
facility: US1222
state: New Jersey
city: New York
country: United States
facility: US1317
state: New York
city: Rochester
country: United States
facility: US1171
state: New York
city: Staten Island
country: United States
facility: US1190
state: New York
city: Cincinnati
country: United States
facility: US1051
state: Ohio
city: Cleveland
country: United States
facility: US1054
state: Ohio
city: Middleburg Heights
country: United States
facility: US1334
state: Ohio
city: Oklahoma City
country: United States
facility: US1323
state: Oklahoma
city: Oklahoma City
country: United States
facility: US1329
state: Oklahoma
city: Austin
country: United States
facility: US1328
state: Texas
city: Plano
country: United States
facility: US1320
state: Texas
city: San Antonio
country: United States
facility: US1162
state: Texas
city: Orem
country: United States
facility: US1308
state: Utah
city: Richmond
country: United States
facility: US1309
state: Virginia
city: Targovishte
country: Bulgaria
facility: BG1023
city: Varna
country: Bulgaria
facility: BG1025
city: Calgary
country: Canada
facility: CA1036 University of Calgary
city: Toronto
country: Canada
facility: CA1038
city: Barranquilla
country: Colombia
facility: CO1003
city: Bello
country: Colombia
facility: CO1001
city: Bogotá
country: Colombia
facility: CO1004
city: Pereira
country: Colombia
facility: CO1002
city: Tallinn
country: Estonia
facility: EE1007
city: Viljandi
country: Estonia
facility: EE1015
city: Douai
country: France
facility: FR1041
city: Elancourt
country: France
facility: FR1017
city: Nantes
country: France
facility: FR1009
city: Freiburg
country: Germany
facility: DE1078
city: Mainz
country: Germany
facility: DE1034
city: Mannheim
country: Germany
facility: DE1077
city: Maulbronn
country: Germany
facility: DE1081
city: Tübingen
country: Germany
facility: DE1076
city: Budapest
country: Hungary
facility: HU1023
city: Gyula
country: Hungary
facility: HU1020
city: Cagliari
country: Italy
facility: IT1075
city: Genova
country: Italy
facility: IT1073
city: Messina
country: Italy
facility: IT1029
city: Napoli
country: Italy
facility: IT1068
city: Padova
country: Italy
facility: IT1074
city: Pisa
country: Italy
facility: IT1070
city: Rome
country: Italy
facility: IT1072 Osppedale Bambin gesu
city: Cheonan
country: Korea, Republic of
facility: KR1035
city: Gyeongsang
country: Korea, Republic of
facility: UA1037
city: Seoul
country: Korea, Republic of
facility: KR1032
city: Seoul
country: Korea, Republic of
facility: KR1038
city: Jelgava
country: Latvia
facility: LV1002
city: Liepaja
country: Latvia
facility: LV1008
city: Riga
country: Latvia
facility: LV1009
city: Sigulda
country: Latvia
facility: LV1007
city: Ciudad de mexico
country: Mexico
facility: MX1003
city: Culiacán
country: Mexico
facility: MX1014
city: Guadalajara
country: Mexico
facility: MX1011
city: Guadalajara
country: Mexico
facility: MX1013
city: Guadalajara
country: Mexico
facility: MX1022
city: Mazatlán
country: Mexico
facility: MX1023
city: Nuevo León
country: Mexico
facility: MX1001
city: Bialystok
country: Poland
facility: PL1002
city: Gdansk
country: Poland
facility: PL1050
city: Kielce
country: Poland
facility: PL1068
city: Lublin
country: Poland
facility: PL1057
city: Poznan
country: Poland
facility: PL1052
city: Wroclaw
country: Poland
facility: PL1051
city: Wąbrzeźno
country: Poland
facility: PL1054
city: Arkhangel'sk
country: Russian Federation
facility: RU1009
city: Ekaterinburg
country: Russian Federation
facility: RU1016
city: Engel's
country: Russian Federation
facility: RU1059
city: Krasnodar
country: Russian Federation
facility: RU1046
city: Lipetsk
country: Russian Federation
facility: RU1011
city: Nizhniy Novgorod
country: Russian Federation
facility: RU1004
city: Novosibirsk
country: Russian Federation
facility: RU1010
city: Rostov on Don
country: Russian Federation
facility: RU1012
city: Rostov-na-Donu
country: Russian Federation
facility: RU1044
city: Saratov
country: Russian Federation
facility: RU1013
city: Saratov
country: Russian Federation
facility: RU1038
city: St.Petersburg
country: Russian Federation
facility: RU1030
city: Tomsk
country: Russian Federation
facility: RU1057
city: Tonnel'nyy
country: Russian Federation
facility: RU1048
city: Belgrade
country: Serbia
facility: RS1006 Clinic of Neurology and Psychiatry for Children and Adolescents
city: Belgrad
country: Serbia
facility: RS1010
city: Kragujevac
country: Serbia
facility: RS1011
city: Niš
country: Serbia
facility: RS1003
city: Novi Sad
country: Serbia
facility: RS1007
city: Cape Town
country: South Africa
facility: ZA1019
city: Randburg
country: South Africa
facility: ZA1022
city: Sandton
country: South Africa
facility: ZA1023
city: Alcorcon
country: Spain
facility: ES1041
city: Madrid
country: Spain
facility: ES1044
city: Pamplona
country: Spain
facility: ES1043
city: Sabadell
country: Spain
facility: ES1018 Hospital de Sabadell
city: Torremolinos
country: Spain
facility: ES1040
city: Kyiv
country: Ukraine
facility: UA1002
city: Odessa
country: Ukraine
facility: UA1019
city: Poltava
country: Ukraine
facility: UA1001
city: Ternopil'
country: Ukraine
facility: UA1004
city: Glasgow
country: United Kingdom
facility: GB1051
city: Liverpool
country: United Kingdom
facility: GB1047
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.