Vortioxetine to Prevent Return of Symptoms in Children With Depression
Study Details
Study Description
Brief Summary
The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 3 |
Detailed Description
The study consists of a 12-week open-label, flexible-dose treatment period with vortioxetine, followed by a 26-week, randomized, double-blind, fixed-dose, placebo-controlled relapse-prevention period. There will be a safety follow up 4 weeks after the end of the 26-week double-blind treatment period.
The study population will include 'de novo' patients as well as 'rollover' patients from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Vortioxetine -open label treatment period Vortioxetine - 5, 10, 15, and 20 mg/day, film-coated tablets, orally once daily. Patients will receive a targeted dose of 10 mg/day vortioxetine, however the investigator has the possibility to adjust the dose in case of unsatisfactory response or in case of dose-limiting adverse events. |
Drug: Vortioxetine
Tablets
Other Names:
|
Experimental: Vortioxetine -double-blind relapse prevention period Vortioxetine - 5, 10, 15, and 20 mg/day, encapsulated film-coated tables, orally once daily. In the double-blind period, the patients will continue on the same fixed dose as during the end of the open label period |
Drug: Vortioxetine
Tablets
Other Names:
|
Placebo Comparator: Placebo -double-blind relapse prevention period Placebo - encapsulated tablets, orally once daily. |
Drug: Placebo
Tablets
|
Outcome Measures
Primary Outcome Measures
- Time to relapse [Baseline/Randomisation to week 26 in the double-blind treatment period]
Relapse defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) total score with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician
Secondary Outcome Measures
- Relapse rate [Baseline/Randomisation to week 26 in the double-blind treatment period]
Relapse defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) total score with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician
- Change from baseline to Week 26 in the CDRS-R total score [Baseline/Randomisation to week 26 in the double-blind treatment period]
- Change from baseline to Week 26 in the Clinical Global Impression - Severity of Illness (CGI-S) score [Baseline/Randomisation to week 26 in the double-blind treatment period]
- Clinical Global Impression - Global Improvement (CGI-I) score at Week 26 [Week 26 in the double-blind treatment period]
- Change from baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) - Patient rated [Baseline/Randomisation to week 26 in the double-blind treatment period]
- Plasma concentration of vortioxetine [Baseline/Randomisation to week 26 in the double-blind treatment period]
Eligibility Criteria
Criteria
Inclusion Criteria:
De novo patients
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The patient has a primary diagnosis of MDD according to DSM-5™ although co-morbid anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and Obsessive Compulsive Disorder (OCD)).
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The patient has a CDRS-R total score ≥45 at the Screening and Baseline Visits.
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The patient has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit
Exclusion Criteria:
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The patient receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.
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The patient presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or Schizophrenia or Schizoaffective Disorder.
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The patient has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum of 4 weeks prior to the study treatment.
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The patient has attempted suicide or is at significant risk of suicide
Other inclusion and exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alliance for Research | Long Beach | California | United States | 90807 |
2 | Atlanta Center for Medical Research | Atlanta | Georgia | United States | 30331 |
3 | AIM Trials, LLC | Plano | Texas | United States | 75093 |
4 | Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS. | Barranquilla | Atlantico | Colombia | 80020 |
5 | Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS | Bogota | DC | Colombia | 111166 |
6 | Psynapsis Salud Mental S.A. | Pereira | Risaralda | Colombia | 660001 |
7 | Linda Keruze's Psychiatric Center, LLC | Liepaja | Latvia | 3401 | |
8 | CRI Centro Regiomontano de Investigacion SC | Monterrey | Nuevo Leon | Mexico | 64060 |
9 | BIND Investigaciones S.C | San Luis Potosi | San Luis Potosí | Mexico | 78213 |
10 | SINACOR - Centro para el Desarrollo de la Medicina Y De Asistencia Medica Especializada S.C | Culiacan De Rosales | Sinaloa | Mexico | 80230 |
11 | Przychodnia Syntonia Izabela Chojnowska-Cwiakala | Kielce | Poland | 25-103 | |
12 | Indywidualna Specjalistyczna Praktyka Lekarska | Poznan | Poland | 60744 | |
13 | Medicorehabilitation Research Center Phoenix | Rostov-On-Don | Rostov State | Russian Federation | 344010 |
14 | GUZ Engels Psychiatric Hospital | Engels | Russian Federation | 413124 | |
15 | Rostov State Medical University of the Minzdravsotsrazvitiya of Russia | Rostov-on-Don | Russian Federation | 344002 | |
16 | Nebbiolo LLC | Tomsk | Russian Federation | 634009 | |
17 | Odessa Regional Psychiatry Hospital No. 2 | Odessa | Ukraine | 65128 |
Sponsors and Collaborators
- H. Lundbeck A/S
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13546A