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

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03108625
• Collaborator: (none)
• Enrollment: 94
• Locations: 31
• Arm: 1
• Actual Duration (Months): 37.5
• Patients Per Site: 3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major	Drug: Vortioxetine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Apr 16, 2020
• Actual Study Completion Date: Apr 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vortioxetine Once daily dosing of vortioxetine (oral tablets) for 78 weeks.	Drug: Vortioxetine; 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

Outcome Measures

Primary Outcome Measures

1. 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

1. Change in CDRS-R total score [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) [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) [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 [Change from study 12712A baseline to Week 104]

   Clinical Global Impression - Severity of Illness

5. CGI-I score [Week 104]

   Clinical Global Impression - Global Improvement

6. 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

7. 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

8. 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

9. 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

10. Change in CGAS score [Change from study 12712A baseline to Week 104]

    Children's Global Assessment Scale

11. Change in PedsQL VAS score [Change from study 12712A baseline to Week 104]

    Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MHAT "Targovishte" AD	Targovishte		Bulgaria
2	DCC Mladost-M	Varna		Bulgaria
3	Marienthal Center of Psychiatry and Psychology	Tallinn		Estonia
4	CHU de Nantes - Hopital Hotel Dieu	Nantes		France
5	Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri	Mainz		Germany
6	Vadaskert Alapitvany	Budapest		Hungary
7	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza	Gyula		Hungary
8	Scientific Institute Fondazione Stella Maris	Calambrone		Italy
9	Universita degli Studi di Messina - Facolta di Medicina e Chirurgia	Messina		Italy
10	Linda Keruze's Psychiatric Center, LLC	Liepāja		Latvia
11	Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak	Białystok		Poland
12	Centrum Badan Klinicznych PI-House Sp. z o.o.	Gdańsk		Poland
13	Przychodnia Syntonia Poradnia Zdrowia Psychicznego	Kielce		Poland
14	SPECTRUM Centrum Neurologii i Psychiatrii	Lublin		Poland
15	Filip Rybakowski Specjalistyczna Praktyka Lekarska	Poznań		Poland
16	Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED"	Wrocław		Poland
17	State Budgetary Healthcare Institution of Sverdlovsk Region	Ekaterinburg		Russian Federation
18	Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health	Krasnodar		Russian Federation
19	Lipetsk Regional Psychoneurological Hospital	Lipetsk		Russian Federation
20	Nizhny Novgorod Region State Institution Of Healthcare	Nizhny Novgorod		Russian Federation
21	Medicorehabilitation Research Center "Phoenix"	Rostov-on-Don		Russian Federation
22	Rostov State Medical University of the Minzdravsotsrazvitiya of Russia	Rostov-on-Don		Russian Federation
23	Guz "Saratov Regional Psychiatric Hospital St. Sofii"	Saratov		Russian Federation
24	Saratov State Medical University	Saratov		Russian Federation
25	State Budgetary Healthcare Institution	Tonnel'nyy		Russian Federation
26	Clinic of Neurology and Psychiatry for Children and Adolescents	Belgrade		Serbia
27	Clinical Center of Vojvodina - Clinic of Psychiatry	Novi Sad		Serbia
28	Cape Trial Centre	Bellville		South Africa
29	Hospital General Universitario Gregorio Maranon	Madrid		Spain
30	Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo	Torremolinos		Spain
31	Alder Hey Childrens Hospital	Liverpool		United Kingdom

Sponsors and Collaborators

• H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT03108625
• Other Study ID Numbers: 12712B; 2015-002658-11
• First Posted: Apr 11, 2017
• Last Update Posted: Jun 24, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by H. Lundbeck A/S: children; adolescent
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Vortioxetine

Study Results

No Results Posted as of Jun 24, 2021