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うつ病患者におけるBI 1569912の異なる用量を試験する研究

基本情報

NCT ID
NCT06558344
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
224
治験依頼者名
Boehringer Ingelheim

概要

This study is open to adults between 18 and 65 years of age with a type of depression called major depressive disorder. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants are put into 4 groups randomly, which means by chance. Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks. Participants are in the study for about 2.5 months. During this time, they visit the study site at least 7 times. At the visits, doctors and their staff ask participants about their depression symptoms. At the end of the study, the results are compared between the groups to see whether the treatment works. The doctors also regularly check the general health of participants and take note of any unwanted effects.

対象疾患

Depressive Disorder, Major

介入

BI 1569912(DRUG)
Placebo matching BI 1569912(DRUG)

実施施設 (6)

医療法人社団ひさわ会 久野マインズタワークリニック

Tokyo, Shibuya-ku, Japan

うえまつメンタルクリニック

Fukuoka, Chikugo, Japan

広田クリニック

Fukuoka, Kurume, Japan

市ヶ谷ひもろぎクリニック

Tokyo, Shinjuku-ku, Japan

医療法人裕和会ゆたか内科 消化器科クリニック

Kanagawa,Sagamihara, Japan

医療法人 新生会賀来メンタルクリニック

Fukuoka, Fukuoka, Japan