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NCT06558344 · ClinicalTrials.gov registry record · Phase 2

A Study to Test Different Doses of BI 1569912 in People With Depression

A Phase 2 study of Depressive Disorder, Major, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
224
Enrollment target
20
Study locations

NCT06558344 is a Phase 2 study of Depressive Disorder, Major that has completed, run by Boehringer Ingelheim. The registered enrollment target is 224 participants, roughly in line with the 238-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The trial reports 20 study locations across 5 states.

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The verdict

NCT06558344, a Phase 2 study of Depressive Disorder, Major, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
224 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG BI 1569912
  • DRUG Placebo matching BI 1569912

Study Locations (20)

California

  • Clinical Innovations, Inc - Bellflower
  • ASCLEPES Research Centers, P.C. dba Alliance Research - Long Beach
  • Excell Research Inc. - Oceanside
  • CiTrials-Riverside-63180 - Riverside
  • Artemis Institute for Clinical Research, LLC - San Diego
  • Lumos Clinical Research - San Jose
  • California Neuroscience Research - Sherman Oaks
  • Pacific Clinical Research Management Group LLC - Upland

Florida

  • Research Centers of America-Hollywood-67537 - Hollywood
  • Clinical Neuroscience Solutions, Inc-Jacksonville-62642 - Jacksonville
  • CCM Clinical Research Group, LLC-Miami-68482 - Miami
  • Optimus U Corporation-Miami-69452 - Miami
  • Clinical Neuroscience Solutions, Inc-Orlando-62685 - Orlando

Georgia

  • Advanced Discovery Research LLC - Atlanta
  • iResearch Atlanta - Decatur
  • Psych Atlanta, PC - Marietta

Massachusetts

  • Copley Clinical - Boston
  • Boston Clinical Trials - Roslindale
  • Adams Clinical - Watertown

Maryland

  • Pharmasite Research, Incorporated - Baltimore

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2024-10-01
Est. Completion 2025-05-12
Phase Phase 2

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT06558344

The ClinicalTrials.gov registry entry for NCT06558344 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 238-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions - of which BI 1569912 is the first listed.

NCT06558344 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT06558344 about?

NCT06558344 is a clinical study titled "A Study to Test Different Doses of BI 1569912 in People With Depression". 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. Thre...

What is the current status of trial NCT06558344?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2024-10-01. Estimated completion is 2025-05-12.

What conditions does trial NCT06558344 study?

This clinical trial studies the following conditions: Depressive Disorder, Major.

What interventions are being tested in trial NCT06558344?

The interventions under investigation include: BI 1569912 (DRUG), Placebo matching BI 1569912 (DRUG).

Who is sponsoring clinical trial NCT06558344?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06558344 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.