Vortioxetine to Prevent Return of Symptoms in Children With Depression

NCT05014919 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: 13546A2010-020493-42
• Study Type: interventional
• Target: 35
• Locations: 7 countries
• Sites: 17

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse

  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

  Baseline, Week 26

• Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26

  Baseline, Week 26

• Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26

  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

  Baseline, Week 26

Study Arms (3)

Vortioxetine -open label treatment period

EXPERIMENTAL

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

Vortioxetine -double-blind relapse prevention period

EXPERIMENTAL

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

Placebo -double-blind relapse prevention period

PLACEBO COMPARATOR

Placebo - encapsulated tablets, orally once daily.

Drug: Placebo

Interventions

Vortioxetine DRUG

Tablets

Also known as: Brintellix, Trintellix

Vortioxetine -double-blind relapse prevention period; Vortioxetine -open label treatment period

Placebo DRUG

Tablets

Placebo -double-blind relapse prevention period

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (17)

Alliance for Research

Long Beach, California, 90807, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

AIM Trials, LLC

Plano, Texas, 75093, United States

Location

Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.

Barranquilla, Atlántico, 80020, Colombia

Location

Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS

Bogotá, DC, 111166, Colombia

Location

Psynapsis Salud Mental S.A.

Pereira, Risaralda Department, 660001, Colombia

Location

Linda Keruze's Psychiatric Center, LLC

Liepāja, 3401, Latvia

Location

CRI Centro Regiomontano de Investigacion SC

Monterrey, Nuevo León, 64060, Mexico

Location

BIND Investigaciones S.C

San Luis Potosí City, San Luis Potosí, 78213, Mexico

Location

SINACOR - Centro para el Desarrollo de la Medicina Y De Asistencia Medica Especializada S.C

Culiacan de Rosales, Sinaloa, 80230, Mexico

Location

Przychodnia Syntonia Izabela Chojnowska-Cwiakala

Kielce, 25-103, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska

Poznan, 60744, Poland

Location

Medicorehabilitation Research Center Phoenix

Rostov-on-Don, Rostov State, 344010, Russia

Location

GUZ Engels Psychiatric Hospital

Engel's, 413124, Russia

Location

Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

Rostov-on-Don, 344002, Russia

Location

Nebbiolo LLC

Tomsk, 634009, Russia

Location

Odessa Regional Psychiatry Hospital No. 2

Odesa, 65128, Ukraine

Location

MeSH Terms

Conditions

Depression

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was terminated based on new efficacy data from another study. The main primary and secondary efficacy objectives were not assessed due to termination of the study and the limited number of participants who completed the double-blind period.

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Study Officials

• Email contact via Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: August 10, 2021
• Primary Completion: March 31, 2022
• Study Completion: April 28, 2022
• Last Updated: January 5, 2023
• Results First Posted: January 5, 2023

Record last verified: 2022-12

Locations

RU (4); UA (1); ME (3); US (3); LA (1); CO (3); PL (2)