エビリファイ徐放性水性懸濁液筋注用（BPにおける気分エピソードの再発抑制）の特定使用成績調査

基本情報

NCT ID: NCT04812379
ステータス: 完了
試験のフェーズ: -
試験タイプ: 観察
目標被験者数: 535
治験依頼者名: Otsuka Pharmaceutical Co., Ltd.

概要

To investigate the safety for an observation period of 52 weeks with use of Abilify prolonged release aqueous suspension for intramuscular (IM) injection in patients with bipolar I disorder for prevention of recurrence/relapse of mood episodes in the routine clinical setting. The early stage safety after the switching from oral aripiprazole to this IM injection is investigated including extrapyramidal syndrome and malignant syndrome. Information regarding efficacy is collected as well.

対象疾患

Bipolar Disorder I

介入

Abilify prolonged release aqueous suspension for IM injection (Aripiprazole)(DRUG)

依頼者（Sponsor）

大塚製薬株式会社(INDUSTRY)

実施施設 (1)

Pharmacovigilance Department

Osaka, Osaka, Japan