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Completed

NCT Number: NCT03108625

Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MHAT "Targovishte" AD, Targovishte, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is a male or female child aged ≥7 and <12 years or an adolescent aged ≥12 and ≤17 years at Baseline in Study 12712B.
  • The patient must have completed extension Study 12712A immediately prior to enrolment into this extension study.
  • The patient had a primary diagnosis of a MDD at entry in Study 12709A or 12710A, diagnosed according to DSM-5™.
  • The patient is still indicated for long-term treatment with vortioxetine according to the clinical opinion of the investigator.

Exclusion criteria

  • The patient has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12712A.
  • The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

Other protocol-defined inclusion and exclusion criteria may apply

Treatment and study plan

Vortioxetine

Drug

Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.

Other names: Brintellix, Lu AA21004

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (Safety)

    Time frame: Up to Week 104

    Based on safety assessments (e.g. paediatric adverse event rating scale (PAERS), clinical safety laboratory tests (including reproductive hormones), vital signs, weight, height, Tanner score, menstrual cycle, ECG, and C-SSRS

Secondary outcomes

  1. Change in CDRS-R total score

    Time frame: Change from study 12712A baseline to Week 104

    Children Depression Rating Scale, revised version

  2. Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)

    Time frame: Up to Week 104

    Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)

  3. Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)

    Time frame: Up to Week 104

    Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)

  4. Change in CGI-S score

    Time frame: Change from study 12712A baseline to Week 104

    Clinical Global Impression - Severity of Illness

  5. CGI-I score

    Time frame: Week 104

    Clinical Global Impression - Global Improvement

  6. Children (7-11 years): change in BRIEF using the Global Executive Composite score

    Time frame: Change from study 12712A baseline to Week 104

    Behaviour Rating Inventory of Executive Function

  7. Children (7-11 years): change in BRIEF using the Megacognition Index

    Time frame: Change from study 12712A baseline to Week 104

    Behaviour Rating Inventory of Executive Function

  8. Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score

    Time frame: Change from study 12712A baseline to Week 104

    Behaviour Rating Inventory of Executive Function, Self-report version

  9. Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index

    Time frame: Change from study 12712A baseline to Week 104

    Behaviour Rating Inventory of Executive Function, Self-report version

  10. Change in CGAS score

    Time frame: Change from study 12712A baseline to Week 104

    Children's Global Assessment Scale

  11. Change in PedsQL VAS score

    Time frame: Change from study 12712A baseline to Week 104

    Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Long-term, Open-label, Flexible-dose, Continuation Extension Study With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2017
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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