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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 : November 29, 2018
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

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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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


  Show 73 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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: November 29, 2018
Last Verified: November 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