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抗うつ薬を服用しているうつ病患者を対象に、BI 1569912の異なる用量を試験する研究

基本情報

NCT ID
NCT06280235
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
84
治験依頼者名
Boehringer Ingelheim

概要

This study is open to adults between 18 and 65 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants continue their standard therapy throughout the study. Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 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 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms. The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants.

対象疾患

Depressive Disorder, Major

介入

BI 1569912(DRUG)
Placebo(DRUG)

実施施設 (10)

医療法人社団ひさわ会 久野マインズタワークリニック

Shibuya-ku, Japan

福岡大学病院

Fukuoka, Fukuoka, Japan

メンタルクリニック桜坂

Fukuoka, Japan

倉光病院

Fukuoka, Japan

三上心療内科・内科医院

Anan-shi, Japan

医療法人 ウェルライフアイさくらクリニック

Fukuoka, Japan

虹と海のホスピタル

Karatsu-shi, Japan

広田クリニック

Kurume-shi, Japan

杏林大学医学部付属病院

Mitaka-shi, Japan

医療法人 新生会賀来メンタルクリニック

Fukuoka, Japan