Vortioxetine to Prevent Return of Symptoms in Children With Depression

NCT ID: NCT05014919

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2022-04-28

Brief Summary

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.

Detailed Description

The study consists of a 12-week open-label, flexible-dose treatment period with vortioxetine, followed by a 26-week, randomized, double-blind, fixed-dose, placebo-controlled relapse-prevention period. There will be a safety follow up 4 weeks after the end of the 26-week double-blind treatment period.

The study population will include 'de novo' participants as well as 'rollover' participants from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vortioxetine -open label treatment period

Vortioxetine - 5, 10, 15, and 20 mg/day, film-coated tablets, orally once daily.

Patients will receive a targeted dose of 10 mg/day vortioxetine, however the investigator has the possibility to adjust the dose in case of unsatisfactory response or in case of dose-limiting adverse events.

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Tablets

Vortioxetine -double-blind relapse prevention period

Vortioxetine - 5, 10, 15, and 20 mg/day, encapsulated film-coated tables, orally once daily.

In the double-blind period, the patients will continue on the same fixed dose as during the end of the open label period

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Tablets

Placebo -double-blind relapse prevention period

Placebo - encapsulated tablets, orally once daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets

Interventions

Vortioxetine

Tablets

Intervention Type: DRUG

Placebo

Tablets

Intervention Type: DRUG

Other Intervention Names

Brintellix; Trintellix

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

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

Countries

United States; Colombia; Latvia; Mexico; Poland; Russia; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2010-020493-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13546A

Identifier Type: -

Identifier Source: org_study_id