BI 1569912 for Depression

No longer recruiting at 12 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must be taking: SSRI, SNRI

Must not be taking: Bupropion, Ketamine

Disqualifiers: Schizophrenia, Bipolar, Personality disorders, others

Compensation: Varies

Number of Visits: 4

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the tolerance and effectiveness of a new medicine, BI 1569912, for individuals with depression who are already on antidepressants. It tests four different doses of BI 1569912, with a placebo group for comparison. Participants should have depression that hasn't responded well to current treatments and be experiencing a depressive episode lasting between 2 months and 1.5 years. The trial lasts about 5 weeks, requiring participants to visit the study site four times and stay for 9 days. Health checks and questionnaires help researchers assess the treatment's impact on depression symptoms. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Will I have to stop taking my current medications?

No, you can continue taking your usual medicine for depression throughout the study.

Is there any evidence suggesting that BI 1569912 is likely to be safe for humans?

Research has shown that BI 1569912 is generally safe for humans. Early data from past studies indicated that participants did not experience severe side effects, even at varying doses. Other studies suggest that BI 1569912 is unlikely to cause feelings of disconnection from reality or heart-related issues, which reassures its safety.

These findings support its ongoing development for treating depression. Although this is a Phase 1 trial focused on safety, earlier research offers a positive outlook on how well participants might tolerate BI 1569912. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BI 1569912 because it offers a novel approach to treating depression. Unlike traditional antidepressants, which often target serotonin or norepinephrine pathways, BI 1569912 works by a different mechanism that may provide relief for individuals who don't respond to existing treatments. This new approach could also mean faster onset of effects, offering hope for quicker relief from depressive symptoms. Additionally, the potential for fewer side effects compared to standard medications makes BI 1569912 a promising option for enhancing patient comfort and adherence.

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

Research has shown that BI 1569912, which participants in this trial may receive, targets a specific part of the brain involved in mood regulation to help people with depression. Early studies suggest that BI 1569912 can quickly ease depression symptoms. For instance, a single 20 mg dose lowered depression scores within a week. This treatment alters the function of certain brain receptors, potentially improving mood. While more research is needed, these early results offer hope for those whose current treatments aren't effective. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

Established diagnosis of Major Depressive Disorder (MDD) as confirmed at the time of screening by the Mini International Neuropsychiatric Interview (MINI), with a duration of current depressive episode ≥ 8 weeks and ≤ 24 months at the time of screening visit.

Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Please note complete sexual abstinence is allowed when this is in line with the preferred and usual lifestyle of the patient (note: periodic abstinence such as calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) - (in this specific case the barrier methods, as mentioned below, are not applicable). Sexual abstinence as a contraceptive method will not be allowed for WOCBP who are heterosexually active.

At least moderate severity of MDD confirmed by a trained site-based rater, at screening and Visit 2 day 1 (i.e. prior to randomisation). For patients who are not on an SSRI at Visit 1, MDD must be confirmed additionally at Visit 1 A.

Exclusion Criteria

Diagnosis with antisocial, paranoid, schizoid, schizotypical or Borderline personality disorder as per DSM-5 criteria at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and is likely to impact trial participation, as per the judgement of investigator.

Patients with a Body Mass Index (weight [kg]/height [m]²) lower than 18 kg/m² at screening.

Stable treatment with benzodiazepines and/or nonbenzodiazepine hypnotics. (Note: As needed (PRN) use of benzodiazepines and/or nonbenzodiazepine hypnotics may be acceptable except for the trial period Day -1 to Day 2).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive a single dose of BI 1569912 or placebo and continue their usual medication for depression

5 weeks

4 visits (in-person), including a 9-day stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including health checks and questionnaires about depression symptoms

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 1569912
• Placebo

How Is the Trial Designed?

Group I: BI 1569912 treatment group Experimental Treatment 1 Intervention

Group II: Placebo group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

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

Safety and Efficacy of the NMDA‐2b‐Selective Negative ... This Phase Ib trial evaluated the safety and preliminary efficacy of BI 1569912, an oral NMDA receptor subunit 2b-selective negative ...

2. 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.

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

A Phase Ib Randomized Trial in Major Depressive Disorder The maximum decrease from baseline in MADRS within a 7-day interval was similar across groups; however, a single BI 1569912 20-mg dose provided ...

4. 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 ...

5. 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 ...

6. biologicalpsychiatryjournal.com biologicalpsychiatryjournal.com/article/S0006-3223(22)01036-8/fulltext

P712. Safety, Tolerability, and Pharmacokinetics of Single ... Preliminary data indicate that BI 1569912 was well tolerated across all doses. Plasma exposure of BI 1569912 increased dose-proportionally ...