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
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ClinicalTrials.gov Identifier: NCT02871297 |
Recruitment Status
:
Enrolling by invitation
First Posted
: August 18, 2016
Last Update Posted
: March 22, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depressive Disorder, Major | Drug: Vortioxetine | Phase 3 |
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 : | April 2019 |
Estimated Study Completion Date : | April 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Vortioxetine
Once daily dosing of vortioxetine (oral tablets) for 26 weeks.
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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:
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- 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)
- Change in CDRS-R total score [ Time Frame: Change from baseline to Week 26 ]Children Depression Rating Scale - Revised version
- 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
- 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
- Change in CGI-S score [ Time Frame: Change from baseline to Week 26 ]Clinical Global Impression - Severity of Illness
- CGI-I score [ Time Frame: Week 26 ]Clinical Global Impression - Global Improvement
- 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
- 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
- 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
- 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
- Change in CGAS score [ Time Frame: Change from baseline to Week 26 ]Children's Global Assessment Scale
- Change in in PedsQL VAS score [ Time Frame: Change from baseline to Week 26 ]Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales

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Ages Eligible for Study: | 7 Years to 18 Years (Child, Adult) |
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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871297

Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com |
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 Key Record Dates |
Last Update Posted: | March 22, 2018 |
Last Verified: | March 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 |