Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)

Официальное название

Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial

Обзор

This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment.

Подробное описание

This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment. Adolescents ages 12 to 17, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) at least 8 weeks and still experiencing depression, participate in a 8-week randomized treatment study that includes one of three conditions: (1) switching to sertraline , (2) switching to duloxetine , (3) augmentation of their original SSRI with aripiprazole.

Вмешательства

• Препарат Sertraline
  Commonly used oral antipsychotics intervention therapy.
• Препарат Agomelatine
  Commonly used oral antipsychotics intervention therapy.
• Препарат Aripiprazole
  Commonly used oral antipsychotics intervention therapy.

Первичные конечные точки

• response rate of Children's Depression Rating Scale (CDRS-R) scores [Срок оценки: Baseline of treatment period, 4 weeks, 8 weeks]

Вторичные конечные точки (4)

• Change in Baker Depression Scale（BDI-II) scores from baseline [Срок оценки: Baseline of treatment period, 4 weeks, 8 weeks]
• Change in The Screen for Child Anxiety-Related Emotional Disorders (SCARED) scores from baseline [Срок оценки: Baseline of treatment period, 4 weeks，8 weeks]
• Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline [Срок оценки: Baseline of treatment period, 4 weeks, 8 weeks,]
• Adverse Event (AE) or Serious Adverse Event (SAE) [Срок оценки: Baseline of treatment period, 1 month, 2 months,]

Критерии участия

Критерии включения

• Aged 12-17;
• As assessed by K-SADS-PL, it meets the DSM-5 criteria for MDD;
• CDRS-R≥45;
• CGI-S≥4;
• Failed to respond to an initial SSRI trial: the trial at least 8 weeks, with the last of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent.

Критерии исключения

• Current or lifetime diagnosis of bipolar disorder, schizophrenia, autism, attention-deficit/hyperactivity disorder or obsessive-compulsive disorder or psychosis not otherwise specified;
• MDD with psychotic symptoms;
• YMRS>13;
• Current or lifetime diagnosis of serious neurologic diseases such as epilepsy, brain trauma or other serious physical illnesses;
• Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length (at least 8 weeks, with the last 4 of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent);
• History of clear-cut intolerability of, or lack of effect with, an adequate trial of sertraline, agomelatine, or aripiprazole;
• Current depressive episode with clear suicidal plans or behaviors;
• Received modified electroconvulsive therapy within 3 months;
• Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment;
• Substance abuse or dependence;
• Female patients with pregnancy.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT07011693 · 1stChongqingCQMU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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