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

Phase 3

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Vortioxetine

• Registration Number: NCT03108625
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Primary Completion: 2020-04-16
• Study Completion: 2020-04-16
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-22
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vortioxetine	Vortioxetine	Once daily dosing of vortioxetine (oral tablets) for 78 weeks.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (Safety)	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 Outcome Measures

Name	Time	Method
Change in CDRS-R total score	Change from study 12712A baseline to Week 104	Children Depression Rating Scale, revised version
Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)	Up to Week 104	Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)
Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)	Up to Week 104	Loss of remission (CDRS-R \<28 with a history of 2 weeks of clinical deterioration)
Change in CGI-S score	Change from study 12712A baseline to Week 104	Clinical Global Impression - Severity of Illness
CGI-I score	Week 104	Clinical Global Impression - Global Improvement
Children (7-11 years): change in BRIEF using the Global Executive Composite score	Change from study 12712A baseline to Week 104	Behaviour Rating Inventory of Executive Function
Children (7-11 years): change in BRIEF using the Megacognition Index	Change from study 12712A baseline to Week 104	Behaviour Rating Inventory of Executive Function
Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score	Change from study 12712A baseline to Week 104	Behaviour Rating Inventory of Executive Function, Self-report version
Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index	Change from study 12712A baseline to Week 104	Behaviour Rating Inventory of Executive Function, Self-report version
Change in CGAS score	Change from study 12712A baseline to Week 104	Children's Global Assessment Scale
Change in PedsQL VAS score	Change from study 12712A baseline to Week 104	Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales

Trial Locations

Locations (31)

MHAT "Targovishte" AD; 🇧🇬 Targovishte, Bulgaria

DCC Mladost-M; 🇧🇬 Varna, Bulgaria

Marienthal Center of Psychiatry and Psychology; 🇪🇪 Tallinn, Estonia

CHU de Nantes - Hopital Hotel Dieu; 🇫🇷 Nantes, France

Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri; 🇩🇪 Mainz, Germany

Vadaskert Alapitvany; 🇭🇺 Budapest, Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza; 🇭🇺 Gyula, Hungary

Scientific Institute Fondazione Stella Maris; 🇮🇹 Calambrone, Italy

Universita degli Studi di Messina - Facolta di Medicina e Chirurgia; 🇮🇹 Messina, Italy

Linda Keruze's Psychiatric Center, LLC; 🇱🇻 Liepāja, Latvia

Scroll for more (21 remaining)