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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 : Recruiting
First Posted : August 18, 2016
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE August 15, 2016
First Posted Date  ICMJE August 18, 2016
Last Update Posted Date September 23, 2021
Actual Study Start Date  ICMJE August 17, 2016
Estimated Primary Completion Date July 29, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
Safety [ Time Frame: Baseline to Week 26 ]
Safety evalution 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 C-SSRS.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
  • Change in CDRS-R total score [ Time Frame: 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 Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: from baseline to Week 26 ]
    Clinical Global Impression - Severity of Illness
  • Clinical Global Impression - Global Improvement (CGI-I) score [ Time Frame: Week 26 ]
    Clinical Global Impression - Global Improvement
  • 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
  • Children (7-11 years): Change in BRIEF using the Metacognition Index [ Time Frame: from baseline to Week 26 ]
    Behaviour Rating Inventory of Executive Function
  • 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
  • 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
  • Change in Children's Global Assessment Scale (CGAS) score [ Time Frame: from baseline to Week 26 ]
    Children's Global Assessment Scale
  • 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
  • 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.
  • 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'.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
  • Change in CDRS-R total score [ Time Frame: Change from baseline to Week 26 ]
    Children Depression Rating Scale - Revised version
  • Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration) [ Time Frame: Up to Week 26 ]
    Children Depression Rating Scale - Revised version
  • 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 ]
  • 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 ]
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • 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
  • Drug: Vortioxetine
    5, 10, 15 or 20 mg
    Other Names:
    • Brintellix (R)
    • Lu AA21004
Study Arms  ICMJE
  • Experimental: Vortioxetine tablets
    Vortioxetine tablets for 26 weeks
    Intervention: Drug: Vortioxetine
  • Experimental: Vortioxetine
    Single dose of vortioxetine oral drops (only a subset of patients)
    Intervention: Drug: Vortioxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2021)
696
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2016)
850
Estimated Study Completion Date  ICMJE July 29, 2022
Estimated Primary Completion Date July 29, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com
Listed Location Countries  ICMJE Bulgaria,   Canada,   Colombia,   Estonia,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Mexico,   Poland,   Russian Federation,   Serbia,   South Africa,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02871297
Other Study ID Numbers  ICMJE 12712A
2008-005356-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP