Vortioxetine to Prevent Return of Symptoms in Children With Depression
- Registration Number
- NCT05014919
- Lead Sponsor
- H. Lundbeck A/S
- 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.
- 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' participants as well as 'rollover' participants from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
De novo participants
- The participant 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)).
- The participant has a CDRS-R total score ≥45 at the Screening and Baseline Visits.
- The participant has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit
- The participant receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.
- The participant 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.
- The participant 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.
- The participant has attempted suicide or is at significant risk of suicide
Other inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo -double-blind relapse prevention period Placebo Placebo - encapsulated tablets, orally once daily. Vortioxetine -double-blind relapse prevention period Vortioxetine 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 Vortioxetine -open label treatment period Vortioxetine 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.
- Primary Outcome Measures
Name Time Method Time to Relapse in the Double-blind Period From randomization to Week 26 in the double-blind treatment period Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26 Baseline, Week 26 The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse From randomization to Week 26 in the double-blind treatment period Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26 Week 26 The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26 Baseline, Week 26 The PQ-LES-Q is a participant-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows participants to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction.
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26 Baseline, Week 26 The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants).
Plasma Concentration of Vortioxetine From randomization to Week 26 in the double-blind treatment period
Trial Locations
- Locations (17)
Linda Keruze's Psychiatric Center, LLC
🇱🇻Liepaja, Latvia
AIM Trials, LLC
🇺🇸Plano, Texas, United States
Medicorehabilitation Research Center Phoenix
🇷🇺Rostov-On-Don, Rostov State, Russian Federation
SINACOR - Centro para el Desarrollo de la Medicina Y De Asistencia Medica Especializada S.C
🇲🇽Culiacan De Rosales, Sinaloa, Mexico
GUZ Engels Psychiatric Hospital
🇷🇺Engels, Russian Federation
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
🇷🇺Rostov-on-Don, Russian Federation
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Alliance for Research
🇺🇸Long Beach, California, United States
Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.
🇨🇴Barranquilla, Atlantico, Colombia
Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS
🇨🇴Bogota, DC, Colombia
Psynapsis Salud Mental S.A.
🇨🇴Pereira, Risaralda, Colombia
Nebbiolo LLC
🇷🇺Tomsk, Russian Federation
Przychodnia Syntonia Izabela Chojnowska-Cwiakala
🇵🇱Kielce, Poland
Indywidualna Specjalistyczna Praktyka Lekarska
🇵🇱Poznan, Poland
BIND Investigaciones S.C
🇲🇽San Luis Potosi, San Luis Potosí, Mexico
CRI Centro Regiomontano de Investigacion SC
🇲🇽Monterrey, Nuevo Leon, Mexico
Odessa Regional Psychiatry Hospital No. 2
🇺🇦Odessa, Ukraine