A Study of the Change in Disease State and Safety of Oral Cariprazine Capsules in the Treatment of Depression in Pediatric Participants (10 to 17 Years of Age) With Bipolar I Disorder

Название протокола
Клинические исследование Depression: Cariprazine, Placebo - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Allergan

Источник Allergan
Краткое содержание

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.

Общий статус Recruiting
Дата начала 2021-04-28
Дата завершения 2024-01-18
Дата первичного завершения 2024-01-18
Фаза Phase 3
Тип исследования Interventional
Первичный результат
Мера Временное ограничение
Number of Participants with Adverse Events Baseline (Week 0) to Week 10
Abnormal Change from Baseline in Vital Signs Baseline (Week 0) to Week 10
Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results Baseline (Week 0) to Week 6
Change in Electrocardiogram (ECG) Baseline (Week 0) to Week 6
Change in Children's Depression Rating Scale - Revised (CDRS-S) Total Score Baseline (Week 0) to Week 10
Регистрация 380
Состояние
  • Depression
  • Bipolar I Disorder
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Cariprazine

Описание: Oral Capsule

Этикетка Arm Group: Cariprazine

Другое имя: Vraylar

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Oral Capsule

Этикетка Arm Group: Placebo

Приемлемость

Критерии:

Inclusion Criteria: - Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). - Current depressive episode is more than 4 weeks and less than 12 months in duration. - Participant has a lifetime history of at least one manic episode. - Children's Depression Rating Scale - Revised (CDRS-R) score > = 45 at Visit 1 and Visit 2. - Young-Mania Rating Scale (YMRS) score < = 12 with YMRS Item 1 (elevated mood) score < = 2 at Visit 1 and Visit 2. - Clinical Global Impression-Severity (CGI-S) scale score of > = 4 (moderately ill) at Visit 1 and Visit 2. Exclusion Criteria: - Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder. - Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder within the 3 months before Screening Visit 1. - History of serotonin syndrome or neuroleptic malignant syndrome. - Four or more episodes of a mood disturbance within the 12 months before Visit 1. - DSM-5 diagnosis of intellectual disability (IQ < 70), autism spectrum disorders, or documented history of chromosomal disorder with developmental impairment. - History of seizures, with the exception of febrile seizures. - Significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures. - Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitors or with any CYP3A4 inducers. - Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component. - Use of a depot antipsychotic within 2 cycles of their respective dosing interval prior to Screening Visit 1. - Treatment with clozapine in a dose of > 50 mg/d in the past 2 years.

Пол:

All

Минимальный возраст:

10 Years

Максимальный возраст:

17 Years

Здоровые волонтеры:

No

Общий Официальный
Фамилия Роль Присоединение
ALLERGAN INC. Study Director Allergan
Общий контакт

Фамилия: ABBVIE CALL CENTER

Телефон: 844-663-3742

Расположение
Объект: Положение дел:
Pillar Clinical Research /ID# 226504 | Bentonville, Arkansas, 72712, United States Recruiting
Advanced Research Center /ID# 227073 | Anaheim, California, 92805, United States Recruiting
Care Access Research /ID# 226316 | Beverly Hills, California, 90212, United States Recruiting
ProScience Research Group /ID# 226223 | Culver City, California, 90230-6632, United States Completed
Alliance Research /ID# 226522 | Long Beach, California, 90807, United States Recruiting
Prospective Research Innovations Inc /ID# 240774 | Rancho Cucamonga, California, 91730, United States Not yet recruiting
University of California, San Diego Department of Psychiatry /ID# 226463 | San Diego, California, 92103-8229, United States Recruiting
Pacific Clinical Research Management Group /ID# 227075 | Upland, California, 91786-3676, United States Recruiting
Advanced Research Institute of Miami /ID# 228222 | Homestead, Florida, 33030-4613, United States Recruiting Jessica Rodriguez 305-246-0001
South Florida Research Ph I-IV /ID# 240778 | Miami Springs, Florida, 33166-7225, United States Not yet recruiting
Columbus Clinical Services, Llc /Id# 229792 | Miami, Florida, 33125-5114, United States Recruiting Alida Reinoso 305-631-6991 
Florida Research Center, Inc. /ID# 240775 | Miami, Florida, 33174, United States Not yet recruiting
Atlanta Center for Medical Research /ID# 226480 | Atlanta, Georgia, 30331, United States Recruiting
iResearch Atlanta, LLC /ID# 228695 | Decatur, Georgia, 30030, United States Recruiting
Atlanta Behavioral Research, LLC /ID# 226486 | Dunwoody, Georgia, 30338, United States Recruiting
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371 | Stockbridge, Georgia, 30281, United States Recruiting
Baber Research Group /ID# 232279 | Naperville, Illinois, 60563-6502, United States Recruiting
The Kennedy Krieger Institute /ID# 226509 | Baltimore, Maryland, 21205, United States Not yet recruiting
NeuroCognitive and Behavioral Institute, Inc /ID# 227077 | Mount Arlington, New Jersey, 07856-1315, United States Recruiting
UB Department of Psychiatry /ID# 226373 | Buffalo, New York, 14215, United States Not yet recruiting Sevie Kandefer 716-898-4038 
Berma Research Group /ID# 229782 | Kinston, North Carolina, 28501-1603, United States Recruiting
Quest Therapeutics of Avon Lake /ID# 226349 | Avon Lake, Ohio, 44012, United States Recruiting
University of Cincinnati /ID# 226465 | Cincinnati, Ohio, 45219, United States Recruiting
CincyScience /ID# 226318 | West Chester, Ohio, 45069, United States Recruiting
IPS Research Company /ID# 227072 | Oklahoma City, Oklahoma, 73106, United States Recruiting
Sooner Clinical Research /ID# 226384 | Oklahoma City, Oklahoma, 73112, United States Recruiting
Cutting Edge Research Group /ID# 240777 | Oklahoma City, Oklahoma, 73116-1423, United States Not yet recruiting
BioBehavioral Research of Austin /ID# 227076 | Austin, Texas, 78759-5290, United States Recruiting
Relaro Medical Trials /ID# 227156 | Dallas, Texas, 75243, United States Recruiting
Southwest Biomed Research Center LLC /ID# 226340 | Houston, Texas, 77063, United States Completed
Red Oak Psychiatry Associates /ID# 240776 | Houston, Texas, 77090-2641, United States Not yet recruiting
AIM Trials /ID# 226367 | Plano, Texas, 75093, United States Recruiting
Family Psychiatry of The Woodlands /ID# 226290 | The Woodlands, Texas, 77381, United States Recruiting
Asociatia Comunitatea Oamenilor /ID# 226514 | Craiova, Dolj, 200157, Romania Not yet recruiting
Clinica de Neuropsihiatrie Infantila Timisoara /Id# 226347 | Timisoara, Timis, 300329, Romania Not yet recruiting
Institutul de Psihiatrie Socola Iasi /ID# 226200 | Iasi, 700282, Romania Not yet recruiting
Psychotherapeutics Center Podderzhka /ID# 226348 | Stavropol, Stavropol Skiy Kray, 355029, Russian Federation Recruiting
Clinica of Glazunova /ID# 229416 | Krasnodar, 350051, Russian Federation Recruiting
Scientific Centre of Personalized Medicine /ID# 226380 | Moscow, 105082, Russian Federation Recruiting
Central Clinical Psychiatric Hospital /ID# 226381 | Moscow, 127083, Russian Federation Not yet recruiting
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226 | Nizhny Novgorod, 603155, Russian Federation Recruiting
Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462 | Orenburg, 460006, Russian Federation Not yet recruiting
I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 226346 | Saint Petersburg, 197341, Russian Federation Not yet recruiting
Medgard Clinic /ID# 228598 | Saratov, 410028, Russian Federation Recruiting
Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222 | Saratov, 410028, Russian Federation Recruiting
Psychiatric hospital #1 /ID# 226516 | St. Petersburg, 190121, Russian Federation Recruiting
National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515 | St. Petersburg, 192019, Russian Federation Recruiting
University Clinical Center Kragujevac /ID# 229138 | Kragujevac, Sumadijski Okrug, 34000, Serbia Not yet recruiting
Clinical Center Vojvodina /ID# 226521 | Novi Sad, Vojvodina, 21000, Serbia Not yet recruiting
Clinic of Neurology and Psychiatry for Children and Youth /ID# 226513 | Belgrade, 11000, Serbia Not yet recruiting
Institute of Mental Health /ID# 227157 | Belgrade, 11108, Serbia Not yet recruiting
Center for mental health protection, Clinical Centre Nis /ID# 229137 | Nis, 18000, Serbia Not yet recruiting
SIC Institute of Health Care for Children and Adolescents of the NAMS of Ukraine /ID# 226506 | Kharkiv, 61153, Ukraine Not yet recruiting
CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 226461 | Lviv, 79021, Ukraine Not yet recruiting
MNCE Odesa Regional Medical Center for Mental Health /ID# 226231 | Odesa, 65006, Ukraine Not yet recruiting
MNCE Odesa Regional Medical Center for Mental Health /ID# 226382 | Odesa, 65006, Ukraine Not yet recruiting
Расположение Страны

Romania

Russian Federation

Serbia

Ukraine

United States

Дата проверки

2021-12-01

Ответственная сторона

Тип: Sponsor

Ключевые слова
  • Depression
  • RGH-188
  • Bipolar I Disorder
  • Vraylar
  • Cariprazine
Имеет расширенный доступ No
Состояние Просмотр
  • Disease
  • Depression
  • Depressive Disorder
Количество рук 2
Группа вооружений

Метка: Placebo

Тип: Placebo Comparator

Описание: Participants will receive Placebo over a 6 week treatment period.

Метка: Cariprazine

Тип: Experimental

Описание: Participants will receive flexible dose Cariprazine over a 6 week treatment period.

Данные пациента Yes
Информация о дизайне исследования

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: Triple (Participant, Investigator, Outcomes Assessor)