| Статус: |
Прекращено
|
| Протокол № | 3112-301-001 |
| Тип: | ММКИ |
| Фаза: | III |
| РКИ № | 345 от 6 июля 2021 г. |
| Начало: | 6 июля 2021 г. |
| Окончание: | 21 июля 2024 г. |
| Пациентов: | 224 |
| Наименование протокола: | 6-недельное многоцентровое рандомизированное двойное слепое, проводимое в параллельных группах, плацебо-контролируемое исследование эффективности и безопасности препарата карипразин, применяемого у детей (10–17 лет) для лечения депрессивных эпизодов, ассоциированных с биполярным расстройством I типа |
| Цель исследования: | Оценка эффективности и безопасности препарата карипразин, применяемого у детей (10–17 лет) для лечения депрессивных эпизодов, ассоциированных с биполярным расстройством I типа |
| Препарат(ы): | Карипразин (RGH-188) |
| Лекарственная форма: | Капсулы 0,5 мг, 0,75 мг, 1,5 мг, 3 мг |
| Разработчик: | ЭббВи Инк (AbbVie Inc.) |
| Страна: | США |
| CRO: | Общество с ограниченной ответственностью "Синеос Хелс РУС", 115114, г Москва, г Москва, ул Летниковская, дом 2, строение 3, эт. 4, пом. 1, ком. 1, Россия |
| Терапевтические области: | Педиатрия;Психиатрия; |
Дополнительная информация:
ClinicalTrials.gov A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
| Статус: | Recruiting |
| Фаза: | Phase 3 |
| Начало: | 28 апреля 2021 г. |
| Окончание: | 29 января 2025 г. |
| Описание: | Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population. Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide. Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. |
| смотреть на ClinicalTrials.gov |