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Depressive Disorder, Major / 5 mg BI 1569912 / 20 mg BI 1569912 · Phase 1 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a completed Phase 1 randomized placebo-controlled trial of BI 1569912 in adults with major depressive disorder inadequately responsive to current antidepressants. No efficacy or safety results are posted in this registry entry, so no evidence-based conclusions can yet be drawn.
Phase 1, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Depressive Disorder, Major; age from 18 Years; to 65 Years. Intervention: 5 mg BI 1569912; 20 mg BI 1569912. Compared with: Placebo — Placebo Comparator. n = 59. 10 sites: United States.
This is a registry record for a completed Phase 1 randomized placebo-controlled trial of BI 1569912 in adults with major depressive disorder inadequately responsive to current antidepressants. No efficacy or safety results are posted in this registry entry, so no evidence-based conclusions can yet be drawn.
Results are not posted in this registry record; efficacy and safety data cannot be assessed. Single-dose administration; does not inform repeated-dosing tolerability or efficacy in clinical practice.
The source did not state who this applies to in practice.
Phase 1 trial with completed enrollment testing tolerability and efficacy of an investigational antidepressant; no results posted in registry, so evidence strength cannot be assessed.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04937829). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 59 participants (ACTUAL). Conditions: Depressive Disorder, Major. Interventions: DRUG: 5 mg BI 1569912; DRUG: 20 mg BI 1569912; DRUG: Placebo. Primary outcome measures: Maximum Decrease From Baseline (Peak Decrease) in Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Any Day Within a 7-day Interval , Evaluations taken at baseline (day -63 to -3) and on day 1, 2, 4, 6 and 8 (with trial drug intake on day 1).; Number of Patients With Drug-related Adverse Events , The on treatment period + Follow up period, up to 15 days.. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.