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

Phase 1

Waitlist Available

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 15

Summary

This trial tests a new medicine called BI 1569912 for adults with depression who haven't improved with other treatments. Participants will take either the medicine or another substance while continuing their usual medication. The study will check if BI 1569912 helps reduce depression symptoms and is safe to use.

Eligible Conditions

Major Depressive Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum decrease from baseline (peak decrease) in Montgomery-Åsberg Depression Rating Scale (MADRS) at any day within a 7 days-interval

Secondary study objectives

Montgomery-Åsberg Depression Rating Scale Area under the response curve from pre-dose to the last measurement during inpatient stay at 166:30 hours (MADRS AUC0-166:30)