Vortioxetine to Prevent Return of Symptoms in Children With Depression

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT05014919
Collaborator
(none)
35
17
3
8.6
2.1
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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' patients as well as 'rollover' patients from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 10, 2021
Actual Primary Completion Date :
Mar 31, 2022
Actual Study Completion Date :
Apr 28, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Time to relapse [Baseline/Randomisation to week 26 in the double-blind treatment period]

      Relapse defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) total score with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician

    Secondary Outcome Measures

    1. Relapse rate [Baseline/Randomisation to week 26 in the double-blind treatment period]

      Relapse defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) total score with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician

    2. Change from baseline to Week 26 in the CDRS-R total score [Baseline/Randomisation to week 26 in the double-blind treatment period]

    3. Change from baseline to Week 26 in the Clinical Global Impression - Severity of Illness (CGI-S) score [Baseline/Randomisation to week 26 in the double-blind treatment period]

    4. Clinical Global Impression - Global Improvement (CGI-I) score at Week 26 [Week 26 in the double-blind treatment period]

    5. Change from baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) - Patient rated [Baseline/Randomisation to week 26 in the double-blind treatment period]

    6. Plasma concentration of vortioxetine [Baseline/Randomisation to week 26 in the double-blind treatment period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    De novo patients

    • The patient 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 patient has a CDRS-R total score ≥45 at the Screening and Baseline Visits.

    • The patient has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit

    Exclusion Criteria:
    • The patient receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.

    • The patient 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 patient 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 patient has attempted suicide or is at significant risk of suicide

    Other inclusion and exclusion criteria may apply.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • H. Lundbeck A/S

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Lundbeck A/S
    ClinicalTrials.gov Identifier:
    NCT05014919
    Other Study ID Numbers:
    • 13546A
    First Posted:
    Aug 20, 2021
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2022