Depressive Disorder, MajorPhase 3NCT03108625
Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
A Phase 3 study testing Vortioxetine in people with Depressive Disorder, Major, run by H. Lundbeck A/S at 31 sites in 13 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Vortioxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 31 sitesin 13 countries
- Study dates
- 1 Mar 2017to 16 Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
31 sites in 13 countries.
31 sites in 13 countries
Russia9 sites
Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health
Krasnodar
Lipetsk Regional Psychoneurological Hospital
Lipetsk
Nizhny Novgorod Region State Institution Of Healthcare
Nizhny Novgorod
Medicorehabilitation Research Center "Phoenix"
Rostov-on-Don
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
Rostov-on-Don
Guz "Saratov Regional Psychiatric Hospital St. Sofii"
Saratov
Saratov State Medical University
Saratov
State Budgetary Healthcare Institution
Tonnel'nyy
State Budgetary Healthcare Institution of Sverdlovsk Region
Yekaterinburg
Poland6 sites
Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak
Bialystok
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk
Przychodnia Syntonia Poradnia Zdrowia Psychicznego
Kielce
SPECTRUM Centrum Neurologii i Psychiatrii
Lublin
Filip Rybakowski Specjalistyczna Praktyka Lekarska
Poznan
Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED"
Wroclaw
Hungary2 sites
Vadaskert Alapitvany
Budapest
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula
Italy2 sites
Scientific Institute Fondazione Stella Maris
Calambrone
Universita degli Studi di Messina - Facolta di Medicina e Chirurgia
Messina
Serbia2 sites
Clinic of Neurology and Psychiatry for Children and Adolescents
Belgrade
Clinical Center of Vojvodina - Clinic of Psychiatry
Novi Sad
Spain2 sites
Hospital General Universitario Gregorio Maranon
Madrid
Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
Torremolinos
About this study
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
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
- Conditions
- Depressive Disorder, Major
- Being tested
- Vortioxetine
- Keywords
- children, adolescent
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called Brintellix, Lu AA21004
Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | Once daily dosing of vortioxetine (oral tablets) for 78 weeks. Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety)
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
Measured: Up to Week 104
Secondary outcomes (11)
Change in CDRS-R total score
Children Depression Rating Scale, revised version
Measured: Change from study 12712A baseline to Week 104
Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)
Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)
Measured: Up to Week 104
Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)
Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)
Measured: Up to Week 104
Change in CGI-S score
Clinical Global Impression - Severity of Illness
Measured: Change from study 12712A baseline to Week 104
CGI-I score
Clinical Global Impression - Global Improvement
Measured: Week 104
Children (7-11 years): change in BRIEF using the Global Executive Composite score
Behaviour Rating Inventory of Executive Function
Measured: Change from study 12712A baseline to Week 104
Children (7-11 years): change in BRIEF using the Megacognition Index
Behaviour Rating Inventory of Executive Function
Measured: Change from study 12712A baseline to Week 104
Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score
Behaviour Rating Inventory of Executive Function, Self-report version
Measured: Change from study 12712A baseline to Week 104
Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index
Behaviour Rating Inventory of Executive Function, Self-report version
Measured: Change from study 12712A baseline to Week 104
Change in CGAS score
Children's Global Assessment Scale
Measured: Change from study 12712A baseline to Week 104
Change in PedsQL VAS score
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales
Measured: Change from study 12712A baseline to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Mar 2017
- Primary completion16 Apr 2020
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108625
- Sponsor's protocol ID
- 12712B
- Other IDs
- 2015-002658-11, 2015
- Status last verified
- Jun 2021
- First submitted
- 10 Mar 2017
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03108625
- Acronym / sponsor ID
- 12712B
- Conditions
- Depressive Disorder, Major
- Keywords
- children, adolescent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Experimental | Drug: VortioxetineOnce daily dosing of vortioxetine (oral tablets) for 78 weeks. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VortioxetineAlso: Brintellix, Lu AA21004Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day. | Drug | Vortioxetine |
Primary outcome
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
11 secondary outcomes
Change in CDRS-R total score
Time frame: Change from study 12712A baseline to Week 104
Number of relapses (CDRS-R ≥40 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)
Time frame: Up to Week 104
Change in CGI-S score
Time frame: Change from study 12712A baseline to Week 104
CGI-I score
Time frame: Week 104
Children (7-11 years): change in BRIEF using the Global Executive Composite score
Time frame: Change from study 12712A baseline to Week 104
Children (7-11 years): change in BRIEF using the Megacognition Index
Time frame: Change from study 12712A baseline to Week 104
Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score
Time frame: Change from study 12712A baseline to Week 104
Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index
Time frame: Change from study 12712A baseline to Week 104
Change in CGAS score
Time frame: Change from study 12712A baseline to Week 104
Change in PedsQL VAS score
Time frame: Change from study 12712A baseline to Week 104
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
Related trials for Depressive Disorder, Major
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
31 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vortioxetine in people with Depressive Disorder, Major, run by H. Lundbeck A/S at 31 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Russia, Poland, Bulgaria, Hungary, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety) (time frame: Up to Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.