Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03108625
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03108625
Recruitment Status : Active, not recruiting
First Posted : April 11, 2017
Last Update Posted : September 20, 2019
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
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 : March 1, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Change from study 12712A baseline to Week 104 ]
    Clinical Global Impression - Severity of Illness

  5. CGI-I score [ Time Frame: Week 104 ]
    Clinical Global Impression - Global Improvement

  6. Children (7-11 years): change in BRIEF using the Global Executive Composite score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from study 12712A baseline to Week 104 ]
    Behaviour Rating Inventory of Executive Function, Self-report version

  10. Change in CGAS score [ Time Frame: Change from study 12712A baseline to Week 104 ]
    Children's Global Assessment Scale

  11. Change in PedsQL VAS score [ Time Frame: Change from study 12712A baseline to Week 104 ]
    Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales



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.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 17 Years   (Child)
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 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


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): NCT03108625


  Show 31 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Layout table for investigator information
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03108625     History of Changes
Other Study ID Numbers: 12712B
2015-002658-11 ( EudraCT Number )
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
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:
Layout table for MeSH terms
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
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