Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

Stopped early · Phase 3

Conditions studied: Depressive Disorder, Major

In brief

Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.

Key facts

Study ID

NCT02871297

Run by

H. Lundbeck A/S

People needed

662

Starts

2016-08-17

Expected to finish

2022-04-19

Last updated by the study team

2022-12-28

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant is a male or female child aged ≥7 and <12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A).
• The participant must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
• The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
• The participant is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
• For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able to understand the Informed Assent Form, and parent(s)/legal representative(s) are able to read and understand the Informed Consent Form.
• For participants who turned 18 years during the lead-in study 12710A; the participant has signed the Informed Consent Form.

You may not qualify if…

• The participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
• The participant has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.
• Other protocol-defined inclusion and exclusion criteria may apply

Where it is running

• Kansas University School of Medicine-Wichita — Wichita, Kansas, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry — Cleveland, Ohio, United States
• MHAT Targovishte AD — Targovishte, Bulgaria
• Diagnostic Consultative Center Mladost-M Varna OOD — Varna, Bulgaria
• Paediatric Sleep Research Inc. — Toronto, Ontario, Canada
• E.S.E. Hospital Mental de Antioquia HOMO — Bello, Antioquia, Colombia
• Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS. — Barranquilla, Atlántico, Colombia
• Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS — Bogotá, DC, Colombia
• Psynapsis Salud Mental S.A. — Pereira, Risaralda Department, Colombia
• Marienthali Kliinik — Tallinn, Estonia
• Cabinet Psyche — Douai, Nord, France
• Centre Medical Ambroise Pare — Élancourt, France
• CHU de Nantes - Hopital Hotel Dieu — Nantes, France
• Univ. Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri — Mainz, Germany
• Klinik fur Kinderneurologie und Sozialpadiatrie Kinderzentrum Maulbronn gGmbH — Maulbronn, Germany
• University Hospital Tuebingen - — Tübingen, Germany
• Vadaskert Child Psychiatric Hospital and Outpatient — Budapest, Hungary
• Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza — Gyula, Hungary
• Ramat Chen - Mental Health Clinic — Tel Aviv, Israel
• Scientific Institute Fondazione Stella Maris — Calambrone, Pisa, Italy
• Sciaf Ulss 16 Padova — Padova, Regione Veneto, Italy
• Hospital Trust-University of Cagliari — Cagliari, Italy
• The University of Arizona Sarver Heart Center (SHC) — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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