Vortioxetine to Prevent Return of Symptoms in Children With Depression

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Depression

In brief

The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.

Key facts

Study ID

NCT05014919

Run by

H. Lundbeck A/S

People needed

35

Starts

2021-08-10

Expected to finish

2022-04-28

Last updated by the study team

2023-01-05

Who can join

Age: 7 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• De novo participants
• The participant has a primary diagnosis of MDD according to DSM-5™ although co-morbid anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and Obsessive Compulsive Disorder (OCD)).
• The participant has a CDRS-R total score ≥45 at the Screening and Baseline Visits.
• The participant has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit

You may not qualify if…

• The participant receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.
• The participant presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or Schizophrenia or Schizoaffective Disorder.
• The participant has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum of 4 weeks prior to the study treatment.
• The participant has attempted suicide or is at significant risk of suicide
• Other inclusion and exclusion criteria may apply.

Where it is running

• Alliance for Research — Long Beach, California, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• AIM Trials, LLC — Plano, Texas, United States
• 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
• Linda Keruze's Psychiatric Center, LLC — Liepāja, Latvia
• CRI Centro Regiomontano de Investigacion SC — Monterrey, Nuevo León, Mexico
• BIND Investigaciones S.C — San Luis Potosí City, San Luis Potosí, Mexico
• SINACOR - Centro para el Desarrollo de la Medicina Y De Asistencia Medica Especializada S.C — Culiacan de Rosales, Sinaloa, Mexico
• Przychodnia Syntonia Izabela Chojnowska-Cwiakala — Kielce, Poland
• Indywidualna Specjalistyczna Praktyka Lekarska — Poznan, Poland
• Medicorehabilitation Research Center Phoenix — Rostov-on-Don, Rostov State, Russia
• GUZ Engels Psychiatric Hospital — Engel's, Russia
• Rostov State Medical University of the Minzdravsotsrazvitiya of Russia — Rostov-on-Don, Russia
• Nebbiolo LLC — Tomsk, Russia
• Odessa Regional Psychiatry Hospital No. 2 — Odesa, Ukraine

Full record on ClinicalTrials.gov

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