A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression

Официальное название

A Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Treatment of Major Depressive Episode Associated With Bipolar I or II Disorder

Обзор

This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features. This study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.

Вмешательства

• Препарат Abilify 2, 5, 10, 15mg (Tablet)
  Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.
• Препарат Placebo of Abilify 2, 5, 10, 15mg (Tablet)
  Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.

Первичные конечные точки

• Mean change in the Montgomery-Åsberg Depression Rating Scale total score [Срок оценки: Week 8]

Вторичные конечные точки (4)

• Mean change in the Clinical Global Impression-BP version Severity of Illness (Depression) score [Срок оценки: Week 8]
• Response rate [Срок оценки: Week 8]
• Remission rate [Срок оценки: Week 8]
• Percentage of subjects with Clinical Global Impression-BP version Severity of Illness (Depression) score of 1 or 2 [Срок оценки: Week 8]

Критерии участия

Критерии включения

• Patients aged ≥ 19 and < 70 years at the time of informed consent
• Patients who are able to understand information required for providing a consent
• Patients who have received a mood stabilizer (lithium or valproic acid)
• Patients with bipolar I or II disorder accompanied by major depressive episode
• Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits

Критерии исключения

• Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features
• Patients considered to have a high risk of suicide during the study period by the investigator based on current psychotic symptom and the patient's past medical history

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

South Korea · 1 центр

• Seounl National University Hospital — Seoul

Идентификаторы

NCT: NCT03423680 · 031-402-00154

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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