NCT04937829

A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication

Randomized, Double-blind (Patient, Investigator), Placebo-controlled, Parallel Group, Single Dosing Study on Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of BI 1569912 as Adjunctive Therapy in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults between 18 and 65 years of age who have depression (major depressive disorder). People with a current depressive episode lasting between 2 months and one and a half years can join the study. This study is for people for whom existing treatments for depression do not work sufficiently. The purpose of this study is to test how well a medicine called BI 1569912 is tolerated and whether it may help people with depression. It is planned to test 4 different dosages of BI 1569912 in this study. Each participant gets either one BI 1569912 dosage or placebo. It is decided randomly, which means by chance, who gets which treatment. Participants take BI 1569912 or placebo as tablets once during the study. Placebo tablets look like BI 1569912 tablets but do not contain any medicine. Participants also continue taking their usual medicine for depression throughout the study. Participants are in the study for about 5 weeks. During this time, they visit the study site 4 times, with a stay at the study site for 9 days. The doctors check the health of the participants and note any health problems that could have been caused by BI 1569912. The participants fill in questionnaires about their depression symptoms.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	BI 1569912	BI 1569912
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-07-20
• Primary completion: 2023-11-16
• Completion: 2023-11-16
• First posted: 2021-06-24
• Last updated: 2023-11-30

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study