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NCT06558344
A Study to Test Different Doses of BI 1569912 in People With Depression
Phase 2 trial testing BI 1569912 in Depressive Disorder, Major in 224 participants. Completed in 12 May 2025.
2 May 2025
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 224 |
| Start date | 1 October 2024 |
| Primary completion | 2 May 2025 |
| Estimated completion | 12 May 2025 |
| Sites | 41 locations across Japan, United States |
Drugs / interventions tested
- BI 1569912 — full drug profile →
- Placebo matching BI 1569912 — full drug profile →
Conditions studied
- Depressive Disorder, Major — all drugs for Depressive Disorder, Major →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
Adults 18 to 65, any sex, with Depressive Disorder, Major. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety and Efficacy of the NMDA-2b-Selective Negative Allosteric Modulator BI 1569912: A Phase Ib Randomized Trial in Major Depressive Disorder.
McIntyre RS, Sanacora G, Walling DP, Cohen EA, et al · · 2025 · PMID 40810366 · DOI 10.1002/cpt.70018
Verify or expand the search:
- PubMed search for NCT06558344
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BI 1569912
Trials testing the same drug.
- NCT06367153 — A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropio · Phase 1 · completed
- NCT06280235 — A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine · Phase 2 · completed
- NCT04978506 — A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated · Phase 1 · completed
- NCT04958252 — A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are · Phase 1 · unknown
- NCT04937829 — A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Wh · Phase 1 · completed
Other recruiting trials for Depressive Disorder, Major
Currently open trials in the same condition.
- NCT07227454 — A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder · Phase 3 · recruiting
- NCT07258485 — A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major · recruiting
- NCT07059234 — The Motor Activity - Subjective Energy (MASE) Project · NA · recruiting
- NCT06982820 — Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia · NA · recruiting
- NCT05553353 — Dosing rTMS for Depression Post-SCI · NA · recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
- NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
- NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
- NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
- NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
- NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06558344 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
- Last refreshed: 6 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06558344.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing