Depressive Disorder, Major
Conditions
Keywords
children, adolescent
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
Interventions
DRUGVortioxetine
Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration) | Up to Week 104 | Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration) |
| Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration) | Up to Week 104 | Loss of remission (CDRS-R \<28 with a history of 2 weeks of clinical deterioration) |
| Change in CGI-S score | Change from study 12712A baseline to Week 104 | Clinical Global Impression - Severity of Illness |
| CGI-I score | Week 104 | Clinical Global Impression - Global Improvement |
| Children (7-11 years): change in BRIEF using the Global Executive Composite score | Change from study 12712A baseline to Week 104 | Behaviour Rating Inventory of Executive Function |
| Change in CDRS-R total score | Change from study 12712A baseline to Week 104 | Children Depression Rating Scale, revised version |
| Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score | Change from study 12712A baseline to Week 104 | Behaviour Rating Inventory of Executive Function, Self-report version |
| Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index | Change from study 12712A baseline to Week 104 | Behaviour Rating Inventory of Executive Function, Self-report version |
| Change in CGAS score | Change from study 12712A baseline to Week 104 | Children's Global Assessment Scale |
| Change in PedsQL VAS score | Change from study 12712A baseline to Week 104 | Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales |
| Children (7-11 years): change in BRIEF using the Megacognition Index | Change from study 12712A baseline to Week 104 | Behaviour Rating Inventory of Executive Function |
Countries
Bulgaria, Estonia, France, Germany, Hungary, Italy, Latvia, Poland, Russia, Serbia, South Africa, Spain, United Kingdom
Outcome results
None listed