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Идёт набор NCT04245436

Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)

Фаза IV С лечением Anxiety Depressive Symptoms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Duloxetine, Escitalopram.
Кому может быть актуально
Состояния в реестре: Anxiety, Depressive Symptoms. Базовые параметры: 12 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up.

Обзор

Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.

Подробное описание

To identify predictors of the magnitude and trajectory of response to flexibly-dosed duloxetine and escitalopram response in adolescents with anxiety, including those with depressive symptoms. And also to examine long-term predictors of sustained response and relapse in adolescents. To examine predictors of developing depressive disorders in anxious adolescents.

Вмешательства

  • Препарат Duloxetine
    Encapsulated duloxetine 30 mg, 60 mg; once-daily
  • Препарат Escitalopram
    Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily

Первичные конечные точки

  • Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score [Срок оценки: Baseline to Week 24 months (Early Term)]
  • Change from Baseline in the Clinical Global Impression of Severity (CGI-S) [Срок оценки: Baseline to Week 10 (Early Term)]

Критерии участия

Критерии включения

  • Written, informed assent and consent.
  • Patients, parent/guardian/LAR must be fluent in the English.
  • 12 to 17 years of age, inclusive, at Screening.
  • Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI-KID.
  • Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of the investigational product.
  • No clinically significant abnormalities on physical examination.
  • Negative pregnancy test at Screening in females.
  • Negative urine drug screen at Screening.
  • Sexually active patients must practice a reliable method of contraception (Section 15.0) that will continue for the duration of the study and for a minimum of 30 days following the end of study participation. Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted:
  • Surgical sterilization
  • Oral contraceptives (e.g. estrogren-progestin combination or progestin)
  • Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
  • Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
  • An intrauterine device
  • Diaphragm plus condom.

Критерии исключения

  • DSM-512 diagnosis other than generalized anxiety, social anxiety, separation anxiety or panic disorder(s) that is the primary focus of treatment.
  • A history of intellectual disability.
  • Suicide risk as determined by either: (1) any suicide attempt within the past 6 months and/or (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator.
  • Allergy, intolerance, non-response or hypersensitivity to escitalopram or duloxetine.
  • Subjects taking other medications that require a taper or washout of more than 5 days.
  • Patients who have initiated/terminated psychotherapy/behavior therapy within 1 month before Visit 2 (Baseline), or who plan to initiate/change said therapies during the course of the study will be excluded; if the patient is engaged in psychotherapy, it must have been stable for 1 month prior to baseline.
  • A clinically-significant medical illness.
  • QTc >450 in males / >460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG81
  • Alcohol or substance use disorder within the past 6 months (nicotine use is permitted).
  • Positive urine pregnancy test/pregnancy or breast feeding.
  • A positive urine drug screen.
  • Patients who are unable to swallow capsules.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Cincinnati — Cincinnati

Идентификаторы

NCT: NCT04245436 · Strawn AtLAS-A

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗