Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)

NCT02709655 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 12709A2008-005353-38
• Study Type: interventional
• Target: 683
• Locations: 18 countries
• Sites: 97

Brief Summary

Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).

Conditions

Depressive Disorder, Major

Keywords

paediatric

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B

  The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). Least square (LS) mean was estimated using a restricted maximum likelihood (REML)-based Mixed Model Repeated Measurements (MMRM) approach.

  Baseline (Week 4 of Phase A), Week 8 of Phase B

Secondary Outcomes (20)

• Change From Baseline in CDRS-R Total Score at Weeks 2, 4, and 6 of Phase B

  Baseline (Week 4 of Phase A), Weeks 2, 4, and 6 of Phase B

• Change From Baseline in CDRS-R Subscores (Mood, Somatic, Subjective, and Behaviour) at Weeks 2, 4, 6, and 8 of Phase B

  Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B

• Percentage of Participants With CDRS-R Response

  Weeks 2, 4, 6, and 8 of Phase B

• Percentage of Participants With CDRS-R Remission

  Weeks 2, 4, 6, and 8 of Phase B

• Change From Baseline in General Behaviour Inventory (GBI) Depression Subscale Score, Using the 10-Item Depression Subscale Assessed by Parent (PGBI-10D) and Child (CGBI-10D) at Weeks 2, 4, 6, and 8 of Phase B

  Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B

Study Arms (4)

Vortioxetine 10 mg/day

EXPERIMENTAL

Drug: Vortioxetine 10 mg/day

Vortioxetine 20 mg/day

EXPERIMENTAL

Drug: Vortioxetine 20 mg/day

Fluoxetine 20 mg/day,

ACTIVE COMPARATOR

A decision has been taken to stop recruitment into this treatment arm.

Drug: Fluoxetine 20mg/day

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Vortioxetine 10 mg/day DRUG

10 mg/day, encapsulated tablet, orally (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

Also known as: Brintellix ®, Lu AA21004

Vortioxetine 10 mg/day

Vortioxetine 20 mg/day DRUG

20 mg/day, encapsulated tablet, orally (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

Also known as: Brintellix ®, Lu AA21004

Vortioxetine 20 mg/day

Fluoxetine 20mg/day DRUG

20 mg/day, encapsulated tablet, orally (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

Fluoxetine 20 mg/day,

Placebo OTHER

Encapsulated tablet, orally

Placebo

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™).
• The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
• The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.
• The participant is a boy or girl, aged ≥7 and \<12 years at Screening Visit
• The participant has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

You may not qualify if:

• The participant has participated in a clinical study \<30 days prior to the Screening Visit.
• The participant has previously participated in a study with vortioxetine.

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Takeda: collaborator

Study Sites (98)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Sun Valley Research Center

Imperial, California, 92251, United States

Location

Synergy Clinical Research Center

Lemon Grove, California, 91945, United States

Location

Alliance for Wellness dba Alliance for Research

Long Beach, California, 90807, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Asclepes Research Center

Panorama City, California, 91402, United States

Location

Children's National Medical Center Merge

Washington D.C., District of Columbia, 20010, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

American Medical Research, Inc.

Chicago, Illinois, 60612, United States

Location

AMR- Baber Research, Inc.

Naperville, Illinois, 60563, United States

Location

AMR Conventions Research

Warrenville, Illinois, 60555, United States

Location

Kansas University School of Medicine-Wichita

Wichita, Kansas, 67214, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Millennium Psychiatric Associates, LLC

St Louis, Missouri, 63132, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Manhattan Behavioral Medicine

New York, New York, 10036, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry

Cleveland, Ohio, 44012, United States

Location

North Star Medical Research, LLC

Middleburg Heights, Ohio, 44130, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73106, United States

Location

Paradigm Research Professionals, LLC

Oklahoma City, Oklahoma, 73118, United States

Location

Research Strategies Of Memphis, Llc

Memphis, Tennessee, 38119, United States

Location

BioBehavioral Research of Austin

Austin, Texas, 78759, United States

Location

AIM Trials, LLC

Plano, Texas, 75093, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Westside Medical

Clinton, Utah, 84015, United States

Location

Aspen Clinical Research, LLC

Orem, Utah, 84058, United States

Location

MHAT Targovishte AD

Targovisthe, 7700, Bulgaria

Location

Diagnostic Consultative Center Mladost-M Varna OOD

Varna, 9020, Bulgaria

Location

Paediatric Sleep Research Inc.

Toronto, Ontario, M5S 3A3, Canada

Location

E.S.E. Hospital Mental de Antioquia HOMO

Bello, Antioquia, 51050, Colombia

Location

Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.

Barranquilla, Atlántico, 80020, Colombia

Location

Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS

Bogotá, DC, 111166, Colombia

Location

Psynapsis Salud Mental S.A.

Pereira, Risaralda Department, Colombia

Location

Marienthali Kliinik

Tallinn, 11315, Estonia

Location

Cabinet Psyche

Douai, Nord, 59500, France

Location

Centre Medical Ambroise Pare

Élancourt, 78990, France

Location

CHU de Nantes - Hopital Hotel Dieu

Nantes, 44093, France

Location

Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri

Mainz, 55122, Germany

Location

Vadaskert Alapitvany

Budapest, 1021, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Gyula, 5700, Hungary

Location

Shalvata Mental Health Center

Hod HaSharon, 4534708, Israel

Location

Ramat Chen - Mental Health Clinic

Tel Aviv, 6435807, Israel

Location

The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital

Tel Litwinsky, 5262000, Israel

Location

Scientific Institute Fondazione Stella Maris

Calambrone Pisa, Pisa, 56026, Italy

Location

Sciaf Ulss 16 Padova

Padua, Regione Veneto, 35143, Italy

Location

University Federico II Of Naples

Napoli, 80131, Italy

Location

Linda Keruze's Psychiatric Center, LLC

Liepāja, LV-3401, Latvia

Location

Children Hospilal -Gailezers

Riga, 1079, Latvia

Location

Centro Investigacion Medico Biologica Y Terapia Avanzada

Guadalajara, Jalisco, 44130, Mexico

Location

Clinica Cemelli

Guadalajara, Jalisco, 44200, Mexico

Location

Roberto Zepeda Sanchez

Guadalajara, Jalisco, 44690, Mexico

Location

Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

Mexico City, Mexico City, 04530, Mexico

Location

CRI Centro Regiomontano de Investigacion SC

Monterrey, Nuevo León, 64060, Mexico

Location

Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C

Culiacan de Rosales, Sinaloa, 80230, Mexico

Location

B & B Investigaciones Medicas, SC

Mazatlán, Sinaloa, 82140, Mexico

Location

ICARO Investigaciones en Medicina S.A. de C.V.

Chihuahua City, 31000, Mexico

Location

BIND Investigaciones S.C

San Luis Potosí City, 78213, Mexico

Location

Prywatne Gabinety Lekarskie Promedicus

Bialystok, Podlaskie Voivodeship, 15879, Poland

Location

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, 80-546, Poland

Location

Przychodnia Syntonia Poradnia Zdrowia Psychicznego

Kielce, 25-103, Poland

Location

Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny

Lublin, 20-884, Poland

Location

Filip Rybakowski Specjalistyczna Praktyka Lekarska

Poznan, 60-744, Poland

Location

Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu

Wałbrzych, 58300, Poland

Location

Medicorehabilitation Research Center Phoenix

Rostov-on-Don, Rostov State, 344010, Russia

Location

Stavropol Region Psychiatric Hospital No.2

Stavropol, Stavropol Kray, 357034, Russia

Location

Arkhangelsk Regional Clinical Mental Hospital

Arkhangelsk, 163530, Russia

Location

GUZ Engels Psychiatric Hospital

Engel's, 413124, Russia

Location

State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...

Krasnodar, 350007, Russia

Location

LLC City Neurological Center Sibneuromed

Novosibirsk, 630091, Russia

Location

Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

Rostov-on-Don, 344022, Russia

Location

City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov

Saint Petersburg, 197341, Russia

Location

Saratov State Medical University

Saratov, 410028, Russia

Location

Guz Saratov Regional Psychiatric Hospital St. Sofii

Saratov, 410060, Russia

Location

Nebbiolo LLC

Tomsk, 634009, Russia

Location

Yaroslavl Regional Clinical Psychiatry Hospital

Yaroslavl, 150003, Russia

Location

State Budgetary Healthcare Institution of Sverdlovsk Region ¿Sverdlovsk Regional Clinical Psychi...

Yekaterinburg, 620030, Russia

Location

Child and Adolescent Neurology and Psychiatry Clinic

Belgrade, 11000, Serbia

Location

Institute of Mental Health

Belgrade, 11000, Serbia

Location

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Clinical Center of Vojvodina - Clinic of Psychiatry

Novi Sad, 21000, Serbia

Location

Daily Hospital for Children and Adolescents

Pantelej-Nis, 18000, Serbia

Location

Cape Trial Centre

Bellville, Cape Town, 7530, South Africa

Location

Tara Hospital

Sandhurst, Gauteng, 2196, South Africa

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo

Torremolinos, Malaga, 29620, Spain

Location

Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...

Kyiv, 04080, Ukraine

Location

Odessa Regional Medical Centre of Mental Health

Odesa, 65006, Ukraine

Location

Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...

Poltava, 36013, Ukraine

Location

Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...

Ternopil, 46000, Ukraine

Location

Related Publications (1)

• Huss M, Findling RL, DelBello MP, Necking O, Petersen ML, Schmidt SN, Rosen M. Vortioxetine for Major Depressive Disorder in Children: 12-Week Randomized, Placebo-Controlled Study. JAACAP Open. 2024 Nov 22;3(3):736-748. doi: 10.1016/j.jaacop.2024.11.002. eCollection 2025 Sep.

  PMID: 40922774 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine; Fluoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Study Officials

• Email contact via Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

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 18, 2016
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: September 22, 2022
• Results First Posted: September 22, 2022

Record last verified: 2022-08

Locations

ES (2); LA (2); PL (6); BU (2); UA (4); RU (13); HU (2); IL (3); SE (5); KR (1); US (34); IT (3); FR (3); DE (1); CA (1); CO (4); ME (9); ZA (2)