Vortioxetine to Prevent Return of Symptoms in Children With Depression

Lundbeck

Status and phase: Terminated; Phase 3

Conditions: Depression

Treatments: Drug: Vortioxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05014919

13546A

2010-020493-42 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 3 patient groups, including a placebo group

Vortioxetine -open label treatment period

Experimental group

Description:

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.

Treatment:

Drug: Vortioxetine

Vortioxetine -double-blind relapse prevention period

Experimental group

Description:

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

Treatment:

Drug: Vortioxetine

Placebo -double-blind relapse prevention period

Placebo Comparator group

Description:

Placebo - encapsulated tablets, orally once daily.

Treatment:

Drug: Placebo