Vortioxetine to Prevent Return of Symptoms in Children With Depression

A Double-blind, Randomized, Placebo-controlled, Multicentre, Relapse-prevention Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder

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.

Study Overview

• Status: Terminated
• Conditions: Depression
• Intervention / Treatment: Drug: Placebo; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 80020
      • Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.
  • DC
    • Bogota, DC, Colombia, 111166
      • Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS
  • Risaralda
    • Pereira, Risaralda, Colombia, 660001
      • Psynapsis Salud Mental S.A.
• Latvia
  • Liepaja, Latvia, 3401
    • Linda Keruze's Psychiatric Center, LLC
• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64060
      • CRI Centro Regiomontano de Investigacion SC
  • San Luis Potosí
    • San Luis Potosi, San Luis Potosí, Mexico, 78213
      • BIND Investigaciones S.C
  • Sinaloa
    • Culiacan De Rosales, Sinaloa, Mexico, 80230
      • SINACOR - Centro para el Desarrollo de la Medicina Y De Asistencia Medica Especializada S.C
• Poland
  • Kielce, Poland, 25-103
    • Przychodnia Syntonia Izabela Chojnowska-Cwiakala
  • Poznan, Poland, 60744
    • Indywidualna Specjalistyczna Praktyka Lekarska
• Russian Federation
  • Engels, Russian Federation, 413124
    • GUZ Engels Psychiatric Hospital
  • Rostov-on-Don, Russian Federation, 344002
    • Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
  • Tomsk, Russian Federation, 634009
    • Nebbiolo LLC
  • Rostov State
    • Rostov-On-Don, Rostov State, Russian Federation, 344010
      • Medicorehabilitation Research Center Phoenix
• Ukraine
  • Odessa, Ukraine, 65128
    • Odessa Regional Psychiatry Hospital No. 2
• United States
  • California
    • Long Beach, California, United States, 90807
      • Alliance for Research
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
  • Texas
    • Plano, Texas, United States, 75093
      • AIM Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Vortioxetine; Tablets; Other Names: Brintellix; Trintellix
Experimental: 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	Drug: Vortioxetine; Tablets; Other Names: Brintellix; Trintellix
Placebo Comparator: Placebo -double-blind relapse prevention period; Placebo - encapsulated tablets, orally once daily.	Drug: Placebo; Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Relapse in the Double-blind Period	Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).	From randomization to Week 26 in the double-blind treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse	Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).	From randomization to Week 26 in the double-blind treatment period
Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26	The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).	Baseline, Week 26
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26	The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants).	Baseline, Week 26
Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26	The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).	Week 26
Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26	The PQ-LES-Q is a participant-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows participants to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction.	Baseline, Week 26
Plasma Concentration of Vortioxetine		From randomization to Week 26 in the double-blind treatment period

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine
• Other Study ID Numbers: 13546A; 2010-020493-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No