BI 1569912 for Depression

Recruiting at56 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boehringer Ingelheim

Disqualifiers: Schizophrenia, Bipolar, Seizure disorders, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug BI 1569912 for depression?

Research shows that lithium, a component often used in combination with other antidepressants, is effective in treating depression, especially in patients who do not respond to initial treatments. Studies have demonstrated that adding lithium to antidepressants can significantly improve symptoms in patients with major depression. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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

Treatment Details

Interventions

• BI 1569912 (Other)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of response to lithium augmentation in tricyclic antidepressant-resistant depression. [2019]

2. United States 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. [2021]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Lithium and desipramine versus desipramine alone in the treatment of severe major depression: a preliminary study. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Role of lithium augmentation in the management of major depressive disorder. [2021]