A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine

Phase 2

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: BI 1569912; Drug: Placebo

• Registration Number: NCT06280235
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Study Start: 2024-03-27
• Primary Completion: 2025-02-26
• Study Completion: 2025-03-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1569912 low dose group	BI 1569912	-
BI 1569912 medium dose group	BI 1569912	-
BI 1569912 high dose group	BI 1569912	-
Placebo group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6	at baseline, at week 6	The MADRS evaluates core symptoms of depression. It is a clinician-rated measure of depression severity and consists of 10 items. MADRS items are rated on a 0-6 continuum (0 = no abnormality, 6 = severe).; The possible total score could range from 0 to 60 - from normal with absence of symptoms to severe depression.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in MADRS total score at Day 8	at baseline, at day 8
Response defined as ≥50% MADRS reduction from baseline at Day 8	at baseline, at day 8
Response defined as ≥50% MADRS reduction from baseline at Week 6	at baseline, at week 6
Remission defined as MADRS total score ≤10 at Week 6	up to 6 weeks
Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8	at baseline, at day 8	The SMDDS is a 16-item, patient-reported outcome (PRO) measure developed to capture the core symptoms of major depressive disorder (MDD).; Participants respond to each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always").; The total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology.; It is calculated by creating first a single score for items 11 and 12 by selecting the highest severity on either item, and then creating the sum of the 15 responses.
Change from baseline in SMDDS total score at Week 4	at baseline, at week 4

Trial Locations

Locations (53)

Hebei Mental Health Center; 🇨🇳 Baoding, China

Kaku Mental Clinic; 🇯🇵 Fukuoka-shi, Japan

Excell Research Inc.; 🇺🇸 Oceanside, California, United States

Southwest Biomedical Research, LLC; 🇺🇸 Tucson, Arizona, United States

NRC Research Institute; 🇺🇸 Orange, California, United States

Asclepes Research Centers-Panorama City-62905; 🇺🇸 Panorama City, California, United States

CT Clinical Research; 🇺🇸 Cromwell, Connecticut, United States

Galiz Research; 🇺🇸 Hialeah, Florida, United States

Premier Clinical Research Institute; 🇺🇸 Miami, Florida, United States

CCM Clinical Research Group, LLC-Miami-68482; 🇺🇸 Miami, Florida, United States

iResearch Atlanta; 🇺🇸 Decatur, Georgia, United States

Chicago Research Center, Incorporated; 🇺🇸 Chicago, Illinois, United States

ActivMed Practices & Research; 🇺🇸 Methuen, Massachusetts, United States

Boston Clinical Trials; 🇺🇸 Roslindale, Massachusetts, United States

Adams Clinical; 🇺🇸 Watertown, Massachusetts, United States

Hassman Research Institute-Marlton-66897; 🇺🇸 Marlton, New Jersey, United States

Neurobehavioral Research, Inc.; 🇺🇸 Cedarhurst, New York, United States

Midwest Clinical Research; 🇺🇸 Dayton, Ohio, United States

Neuro-Behavioral Clinical Research; 🇺🇸 North Canton, Ohio, United States

Sooner Clinical Research; 🇺🇸 Oklahoma City, Oklahoma, United States

Lehigh Center for Clinical Research; 🇺🇸 Allentown, Pennsylvania, United States

Houston Clinical Trials, LLC; 🇺🇸 Bellaire, Texas, United States

Grayline Research Center; 🇺🇸 Wichita Falls, Texas, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

Anima Research Center; 🇧🇪 Alken, Belgium

Universitair Psychiatrisch Centrum Duffel (UPC Duffel); 🇧🇪 Duffel, Belgium

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov; 🇧🇬 Cherven Bryag, Bulgaria

MHC - Ruse, EOOD; 🇧🇬 Rousse, Bulgaria

Medical Center "Sv.Naum"; 🇧🇬 Sofia, Bulgaria

DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan" OOD; 🇧🇬 Sofia, Bulgaria

Medical Center Hera EOOD; 🇧🇬 Sofia, Bulgaria

Medical Center Intermedica Ltd.; 🇧🇬 Sofia, Bulgaria

DCC Mladost-M Varna OOD; 🇧🇬 Varna, Bulgaria

Beijing Anding Hospital; 🇨🇳 Beijing, China

Peking University Sixth Hospital; 🇨🇳 Beijing, China

The Second Xiangya Hospital Of Central South University; 🇨🇳 Changsha, China

Shanghai Mental Health Center; 🇨🇳 Shanghai, China

Shenzhen Kangning Hospital; 🇨🇳 Shenzhen, China

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, China

Tianjin Anding Hospital; 🇨🇳 Tianjin, China

A-SHINE s.r.o; 🇨🇿 Plzen, Czechia

Clintrial s.r.o.; 🇨🇿 Praha, Czechia

Charite Universitätsmedizin Berlin KöR; 🇩🇪 Berlin, Germany

Somni Bene - Institut für Medizinische Forschung & Schlafmedizin Schwerin GmbH; 🇩🇪 Schwerin, Germany

Iwaki Clinic, Tokushima, Psychosomatic Medicine; 🇯🇵 Anan-shi, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka, Fukuoka, Japan

Aisakura Clinic; 🇯🇵 Fukuoka-shi, Japan

Mental Clinic Sakurazaka; 🇯🇵 Fukuoka-shi, Japan

Kuramitsu Hospital; 🇯🇵 Fukuoka-shi, Japan

Rainbow and Sea Hospital; 🇯🇵 Karatsu-shi, Japan

Hirota Clinic; 🇯🇵 Kurume-shi, Japan

Kyorin University Hospital; 🇯🇵 Mitaka-shi, Japan

Maynds Tower Mental Clinic; 🇯🇵 Shibuya-ku, Japan