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BI 1358894の様々な投与量を試験し、境界性パーソナリティ障害患者の症状を軽減するかどうかを調べる研究

基本情報

NCT ID
NCT04566601
ステータス
完了
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
390
治験依頼者名
Boehringer Ingelheim

概要

This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study. Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups and the placebo group are then compared. The doctors also regularly check the general health of the participants.

対象疾患

Borderline Personality Disorder

介入

BI 1358894(DRUG)
Placebo(DRUG)

実施施設 (7)

きしろメンタルクリニック

Kanagawa, Kawasaki, Japan

Kokoro no Clinic Hirao

Fukuoka, Fukuoka, Japan

i Kokoro Clinic Nihonbashi

Tokyo, Chuo-ku, Japan

Hiyoshi Hospital

Kanagawa, Yokohama, Japan

広田クリニック

Fukuoka, Kurume, Japan

公立大学法人 奈良県立医科大学附属病院

Nara, Kashihara, Japan

市ヶ谷ひもろぎクリニック

Tokyo, Shinjuku-ku, Japan