BI 1569912 for Depression

No longer recruiting at 57 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Antidepressants

Disqualifiers: Schizophrenia, Bipolar, Seizure disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, BI 1569912, to determine its effectiveness for major depressive disorder, a type of long-lasting depression. Participants are divided into four groups: three groups receive different doses of the medicine, and one group receives a placebo, a pill with no active medicine. The trial lasts about 2.5 months, with participants taking a pill daily for 6 weeks and attending regular check-ins to discuss symptoms and health. This trial suits those who have experienced major depression for at least 8 weeks but no more than 24 months. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that BI 1569912 is likely safe for people. One study found it usually does not cause dissociative or heart-related side effects, common concerns with similar treatments. Another study suggested it is generally safe, as most participants did not experience serious side effects. These findings support further research on BI 1569912 for treating depression. Although more studies are needed, the current safety data is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Researchers are excited about BI 1569912 for depression because it offers a potentially novel approach compared to existing treatments like SSRIs or SNRIs. Unlike these standard medications, which often target serotonin and norepinephrine, BI 1569912 may work through a different mechanism, possibly affecting other pathways in the brain. This could lead to quicker onset of relief or benefit patients who haven't responded well to traditional therapies. Additionally, with multiple dosing strategies being explored (low, medium, and high doses), there's potential for personalized treatment plans that optimize efficacy and minimize side effects.

What evidence suggests that BI 1569912 might be an effective treatment for depression?

Research suggests that BI 1569912 might help treat major depressive disorder by affecting a specific part of the brain's NMDA receptor involved in mood regulation. It targets the NR2B subunit, which is believed to quickly relieve depression symptoms with fewer side effects, such as feeling disconnected or experiencing heart problems. Early studies showed that BI 1569912 is safe and initially effective, indicating it could be a promising new option for people with depression. Participants in this trial will receive either a low, medium, or high dose of BI 1569912, or a placebo. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults aged 18-65 with major depressive disorder confirmed by MINI, experiencing a current depressive episode lasting ≥8 weeks but ≤24 months. They must have significant depression severity based on HDRS-17 and CGI-S scores, agree to use effective contraception if applicable, and provide informed consent.

Inclusion Criteria

Hamilton Depression Rating Scale-17 (HDRS-17) - Severity scale score ≥20

Clinical Global Impression- Severity Scale (CGI-S) score ≥4

Women of childbearing potential (WOCBP) must be ready and able to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly plus one additional barrier method

Exclusion Criteria

Diagnosis of a moderate to severe substance related disorder as defined by DSM-5 criteria within 6 months prior to screening visit (with exception of caffeine and tobacco)

Per Mini International Neuropsychiatric Interview (MINI), have ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder

Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder, or MDD with psychotic features as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of BI 1569912 or placebo for 6 weeks

6 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 1569912

Trial Overview

The trial tests the antidepressant BI 1569912 at different doses against a placebo in four randomly assigned groups. Participants take the tablets daily for six weeks while their depression symptoms are monitored over approximately 2.5 months through seven study site visits.

How Is the Trial Designed?

Group I: BI 1569912 (medium dose) Experimental Treatment 1 Intervention

Group II: BI 1569912 (low dose) Experimental Treatment 1 Intervention

Group III: BI 1569912 (high dose) Experimental Treatment 1 Intervention

Group IV: Placebo matching BI 1569912 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

In a study of severely depressed patients, combining lithium with desipramine showed a significant improvement in depression scores compared to desipramine alone, particularly noticeable within the first three weeks of treatment.

The combination therapy resulted in a higher number of responders compared to those receiving desipramine alone, indicating that lithium may enhance the efficacy of tricyclic antidepressants in treatment-resistant depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lithium and desipramine versus desipramine alone in the treatment of severe major depression: a preliminary study. Cappiello, A., McDougle, CJ., Delgado, PL., et al.[2019]

In a study of 71 in-patients with therapy-resistant depression, 52% responded positively to lithium augmentation within 4 weeks, indicating its efficacy as a treatment option.

Key predictors of a positive response included greater severity of depression, shorter duration of the current depressive episode, lower triiodothyronine serum levels, and less frequent use of neuroleptic medications or co-diagnosis of personality disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of response to lithium augmentation in tricyclic antidepressant-resistant depression. Bschor, T., Canata, B., Müller-Oerlinghausen, B., et al.[2019]

Lithium augmentation has shown substantial efficacy in treating major depression, with a meta-analysis of 10 randomized controlled trials revealing a significant positive effect compared to placebo, resulting in a response rate of 41.2% versus 14.4% for placebo.

Lithium is recommended as a first-line treatment strategy for patients with treatment-resistant depression, and its mechanisms of action may involve GABAergic, neurotrophic, and genetic effects, although further research is needed to fully understand its role in enhancing the effects of current antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of lithium augmentation in the management of major depressive disorder. Bauer, M., Adli, M., Ricken, R., et al.[2021]

In a study involving 617 patients with bipolar depression, early improvement (≥20% reduction in depression scores) after 2 to 3 weeks of aripiprazole treatment was a strong predictor of later response or remission, with high sensitivity (up to 94%) and negative predictive value (up to 91%).

The findings suggest that if patients show less than 20% improvement after 3 weeks of treatment, it is advisable to consider modifying their treatment plan, as they are unlikely to achieve significant improvement by the end of the 8-week study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive value of early improvement in bipolar depression trials: a post-hoc pooled analysis of two 8-week aripiprazole studies. Kemp, DE., Calabrese, JR., Eudicone, JM., et al.[2021]

In a study of 69 depressive patients treated with citalopram for 4 weeks, adding lithium carbonate significantly improved response rates in nonresponders, with 60% of the CIT-Li group responding compared to only 14% in the CIT-Pl group (p < 0.05).

The combination of citalopram and lithium was well tolerated, showing no pharmacokinetic interactions, and the study highlighted the importance of genetic factors in drug metabolism, particularly involving the CYP2D6 and CYP2C19 enzymes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled study of citalopram with and without lithium in the treatment of therapy-resistant depressive patients: a clinical, pharmacokinetic, and pharmacogenetic investigation. Baumann, P., Nil, R., Souche, A., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06280235

A Study to Test Different Doses of BI 1569912 in People ...

The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants continue their standard therapy ...

2.

ascpt.onlinelibrary.wiley.com

ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.70018

Safety and Efficacy of the NMDA‐2b‐Selective Negative ...

If effective, BI 1569912 may provide a rapid-acting, well-tolerated, oral NR2B NAM with minimal or no dissociative and cardiovascular effects.

3.

boehringer-ingelheim.com

boehringer-ingelheim.com/science-innovation/human-health-innovation/clinical-pipeline/bi-1569912-nr2b-nam

BI 1569912: NR2B NAM

BI 1569912 is an investigational oral NMDA subunit 2b-selective negative allosteric modulator (NR2B NAM) designed to rapidly relieve depressive symptoms in ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40810366/

A Phase Ib Randomized Trial in Major Depressive Disorder

The favorable safety profile and preliminary efficacy signals support continued development of BI 1569912 for adults with MDD. © 2025 Boehringer ...

5.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT04937829

A Study to Test How Well Different Doses of BI 1569912 ...

The possible total score could range from 0 to 60 (from normal with absence of symptoms to severe depression). Up to Day 15. Secondary Outcome Measures ...