Clinical trial NCT05014919: Vortioxetine to Prevent Return of Symptoms in Children With Depression
Official title: A Double-blind, Randomized, Placebo-controlled, Multicentre, Relapse-prevention Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Depression
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-08-20
Enrollment: 35
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Time to Relapse in the Double-blind Period
timeFrame: From randomization to Week 26 in the double-blind treatment period
Secondary outcomes:
measure: Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse
timeFrame: From randomization to Week 26 in the double-blind treatment period
measure: Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26
timeFrame: Baseline, Week 26
measure: Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26
timeFrame: Week 26
measure: Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26
timeFrame: Baseline, Week 26
measure: Plasma Concentration of Vortioxetine
timeFrame: From randomization to Week 26 in the double-blind treatment period
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Alliance for Research
state: California
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: Barranquilla
country: Colombia
facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.
state: Atlantico
city: Bogota
country: Colombia
facility: Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS
state: DC
city: Pereira
country: Colombia
facility: Psynapsis Salud Mental S.A.
state: Risaralda
city: Liepaja
country: Latvia
facility: Linda Keruze's Psychiatric Center, LLC
city: Monterrey
country: Mexico
facility: CRI Centro Regiomontano de Investigacion SC
state: Nuevo Leon
city: San Luis Potosi
country: Mexico
facility: BIND Investigaciones S.C
state: San Luis Potosí
city: Culiacan De Rosales
country: Mexico
facility: SINACOR - Centro para el Desarrollo de la Medicina Y De Asistencia Medica Especializada S.C
state: Sinaloa
city: Kielce
country: Poland
facility: Przychodnia Syntonia Izabela Chojnowska-Cwiakala
city: Poznan
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska
city: Rostov-On-Don
country: Russian Federation
facility: Medicorehabilitation Research Center Phoenix
state: Rostov State
city: Engels
country: Russian Federation
facility: GUZ Engels Psychiatric Hospital
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
city: Tomsk
country: Russian Federation
facility: Nebbiolo LLC
city: Odessa
country: Ukraine
facility: Odessa Regional Psychiatry Hospital No. 2
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via Lundbeck A/S
role: STUDY_DIRECTOR
References: