| Спонсоры |
Ведущий спонсор: H. Lundbeck A/S |
|---|---|
| Источник | H. Lundbeck A/S |
| Краткое содержание | 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. |
| Подробное описание | 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. |
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| Общий статус | Recruiting | ||||||||||||||
| Дата начала | 2021-08-10 | ||||||||||||||
| Дата завершения | 2024-03-05 | ||||||||||||||
| Дата первичного завершения | 2024-03-05 | ||||||||||||||
| Фаза | Phase 3 | ||||||||||||||
| Тип исследования | Interventional | ||||||||||||||
| Первичный результат |
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| Вторичный результат |
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| Регистрация | 150 |
| Состояние |
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| Вмешательство |
Тип вмешательства: Drug Название вмешательства: Vortioxetine Описание: Tablets Тип вмешательства: Drug Название вмешательства: Placebo Описание: Tablets Этикетка Arm Group: Placebo -double-blind relapse prevention period |
| Приемлемость |
Критерии: Inclusion Criteria: De novo patients - 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)). - The patient has a CDRS-R total score ≥45 at the Screening and Baseline Visits. - The patient has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit Exclusion Criteria: - The patient receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed. - 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. - 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. - The patient has attempted suicide or is at significant risk of suicide Other inclusion and exclusion criteria may apply. Пол: All Минимальный возраст: 7 Years Максимальный возраст: 11 Years Здоровые волонтеры: No |
| Общий контакт |
Фамилия: Email contact via H. Lundbeck A/S Телефон: +45 36301311 |
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| Расположение |
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| Расположение Страны |
Colombia Mexico Poland Russian Federation Ukraine United States |
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| Дата проверки |
2022-01-01 |
| Ответственная сторона |
Тип: Sponsor |
| Имеет расширенный доступ | No |
| Состояние Просмотр |
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| Количество рук | 3 |
| Группа вооружений |
Метка: Vortioxetine -open label treatment period Тип: Experimental Описание: 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. Метка: Vortioxetine -double-blind relapse prevention period Тип: Experimental Описание: 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 Метка: Placebo -double-blind relapse prevention period Тип: Placebo Comparator Описание: Placebo - encapsulated tablets, orally once daily. |
| Данные пациента | Undecided |
| Информация о дизайне исследования |
Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |