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Trial record 1 of 1 for:    NCT02871297
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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 : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Vortioxetine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Non-Randomized
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
Actual Study Start Date : August 2016
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vortioxetine tablets
Vortioxetine 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

Experimental: Vortioxetine
Single dose of vortioxetine oral drops (only a subset of patients)
Drug: Vortioxetine
5, 10, 15 or 20 mg
Other Names:
  • Brintellix (R)
  • Lu AA21004




Primary Outcome Measures :
  1. Number of participants with Treatment-Emergent Adverse Events [ Time Frame: Baseline to Week 26 ]
    Safety based on paediatric adverse event rating scale (PAERS), safety assessments (clinical safety laboratory tests, vital signs, weight, height, Tanner score, menstrual cycle, ECG parameters)


Secondary Outcome Measures :
  1. Change in CDRS-R total score [ Time Frame: 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 Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: from baseline to Week 26 ]
    Clinical Global Impression - Severity of Illness

  5. Clinical Global Impression - Global Improvement (CGI-I) score [ Time Frame: Week 26 ]
    Clinical Global Impression - Global Improvement

  6. Children (7-11 years): Change in Behaviour Rating Inventory of Executive Function (BRIEF) using the Global Executive Composite score [ Time Frame: 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: from baseline to Week 26 ]
    Behaviour Rating Inventory of Executive Function

  8. Adolescents (12-18 years): Change in BRIEF-Self-report (SR) using the Global Executive Composite score [ Time Frame: 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: from baseline to Week 26 ]
    Behaviour Rating Inventory of Executive Function - Self-report version

  10. Change in Children's Global Assessment Scale (CGAS) score [ Time Frame: from baseline to Week 26 ]
    Children's Global Assessment Scale

  11. Change in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) score [ Time Frame: from baseline to Week 26 ]
    Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales

  12. Absolute value of palatability scores [ Time Frame: At Visit 5, 7, 9 or 11 ]
    Palatability is evaluated using 5-point facial hedonic scales (FHS) for 4 different attributes: taste, mouthfeel, aftertaste and smell. Palatability item scores will be summarized using descriptive statistics. That is, the item scores will be summarized for each of the four palatability assessments.

  13. Absolute value of acceptability item scores in number of percentage [ Time Frame: At Visit 5, 7, 9 or 11 ]
    Acceptability assessment is based on 3 items: acceptability of the taste, whether the formulation was perceived as easy to take and willingness to take the formulation every day. Acceptability item scores will be summarized using descriptive statistics'. Number with percentage will be presented for each item of 'acceptability'.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02871297    
Other Study ID Numbers: 12712A
2008-005356-25 ( EudraCT Number )
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Keywords provided by H. Lundbeck A/S:
adolescent
children
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists