Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	850 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Study Start Date :	August 2016
Estimated Primary Completion Date :	September 2019
Estimated Study Completion Date :	September 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Vortioxetine; Once daily dosing of vortioxetine (oral tablets) for 26 weeks.	Drug: Vortioxetine; Target dose is 10 mg/day, however, the dose can be down- or uptitrated to 5, 15, or 20 mg/day.; Other Names: Brintellix (R); Lu AA21004

Outcome Measures

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Primary Outcome Measures :

1. Safety [ Time Frame: Baseline to Week 26 ]
   Safety evaluation based on adverse events, paediatric adverse event rating scale (PAERS), clinical safety laboratory tests (including reproductive hormones), vital signs, weight, height, Tanner score, menstrual cycle, ECG, and Columbia Suicide Severity Rating Scale (C-SSRS)

Secondary Outcome Measures :

1. Change in CDRS-R total score [ Time Frame: Change from baseline to Week 26 ]
   Children Depression Rating Scale - Revised version
2. Time to first relapse (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration) [ Time Frame: Up to Week 26 ]
   Children Depression Rating Scale - Revised version
3. Time to first loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration) [ Time Frame: Up to Week 26 ]
   Children Depression Rating Scale - Revised version
4. Change in CGI-S score [ Time Frame: Change from baseline to Week 26 ]
   Clinical Global Impression - Severity of Illness
5. CGI-I score [ Time Frame: Week 26 ]
   Clinical Global Impression - Global Improvement
6. Children (7-11 years): Change in BRIEF using the Global Executive Composite score [ Time Frame: Change from baseline to Week 26 ]
   Behaviour Rating Inventory of Executive Function
7. Children (7-11 years): Change in BRIEF using the Metacognition Index [ Time Frame: Change from baseline to Week 26 ]
   Behaviour Rating Inventory of Executive Function
8. Adolescents (12-18 years): Change in BRIEF-SR using the Global Executive Composite score [ Time Frame: Change from baseline to Week 26 ]
   Behaviour Rating Inventory of Executive Function - Self-report version
9. Adolescents (12-18 years): Change in BRIEF-SR using the Metacognition Index [ Time Frame: Change from baseline to Week 26 ]
   Behaviour Rating Inventory of Executive Function - Self-report version
10. Change in CGAS score [ Time Frame: Change from baseline to Week 26 ]
    Children's Global Assessment Scale
11. Change in in PedsQL VAS score [ Time Frame: Change from baseline to Week 26 ]
    Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales

Eligibility Criteria

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Ages Eligible for Study:	7 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• The patient is a male or female child aged ≥7 and <12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A).
• The patient must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
• The patient had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
• The patient is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
• For patients aged ≥7 and ≤17 years at the Baseline visit; the patient is able to understand the Informed Assent Form, and parent(s)/legal representative(s) are able to read and understand the Informed Consent Form.
• For patients who turned 18 years during the lead-in study 12710A; the patient has signed the Informed Consent Form.

Exclusion Criteria:

• The patient has been diagnosed with another psychiatric disorder (for example mania,bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
• 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

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  Show 71 Study Locations

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:	Email contact via H. Lundbeck A/S	LundbeckClinicalTrials@Lundbeck.com

More Information

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Responsible Party:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT02871297 History of Changes
Other Study ID Numbers:	12712A; 2008-005356-25 ( EudraCT Number )
First Posted:	August 18, 2016
Last Update Posted:	September 5, 2018
Last Verified:	September 2018

Keywords provided by H. Lundbeck A/S:

adolescent; children

Additional relevant MeSH terms:

Depressive Disorder, Major; Neurotransmitter Uptake Inhibitors; Neurotransmitter Agents; Disease; Depressive Disorder; Depression; Pathologic Processes; Mood Disorders; Mental Disorders; Behavioral Symptoms; Vortioxetine; Anti-Anxiety Agents; Tranquilizing Agents	Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Serotonin Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT1 Receptor Antagonists; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists