A study to test different doses of BI 1569912 in people with depression who take anti-depressive medicine

Trial details

Who runs it

Boehringer Ingelheim International GmbH

Trial code

EU 2023-507942-10-00

Record updated

2025. február 10.

Original description

The primary trial objectives are to demonstrate a [...], to evaluate the dose response relationship, and to assess the quantitative treatment effect size.Read full original descriptionShow less

A Phase II, 6-week, multi-centre, randomised, double-blind (participant and investigator), placebo-controlled, dose-finding trial to evaluate the efficacy, tolerability, and safety of different doses of oral BI 1569912 as adjunctive therapy in patients with major depressive disorder

The primary trial objectives are to demonstrate a [...], to evaluate the dose response relationship, and to assess the quantitative treatment effect size.

Inclusion: Male and female participants, 18 to 65 years of age, both inclusively at the time of consent; Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial; 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. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information and in the study protocol; Established diagnosis of MDD, single episode or recurrent, as confirmed at the time of screening by the MINI with a duration of current depressive episode ≥8 weeks at the time of screening visit; Hamilton Depression Rating Scale-17 (HDRS-17) – Severity scale score >17; A documented ongoing monotherapy treatment of ≥6 weeks at the randomisation visit, with an SSRI or SNRI specified in the ISF at adequate dose (at least minimum effective dose as per prescribing information). - The participant must adhere to the screening visit dose of the background SSRI/SNRI until the end of the trial (EoS Visit). Participants should be on a stable dose for at least 4 weeks prior to randomisation. - Participants, who, in addition to their monotherapy with an SSRI/SNRI, are taking additional low dose antidepressant medications for purposes other than treating depressive symptoms, are not excluded. The dose must be less than the lowest dose indicated for MDD; In the current episode, participants have shown insufficient treatment response defined by less than 50% response to a maximum of 4 antidepressant treatments of adequate dose and treatment duration (according to Summary of Product Characteristics) as evaluated by the ATRQ; Further inclusion criteria apply.

Exclusion: Diagnosis of any other mental disorder that was the primary focus of treatment within 6 months prior to screening (as per clinical discretion of the investigator); Diagnosis of a moderate to severe substance related disorder within 6 months prior to screening visit (with exception of caffeine and tobacco); Per 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 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; History or presence (upon clinical examination) of seizure disorders or an increased risk of seizures (first degree relative with epilepsy), stroke, brain tumour or any other major neurological illness that could impact participation in the trial; A current or recent history of clinically significant suicidal ideation with intent within the past 3 months, corresponding to a score of 4 or 5 for ideation on the C-SSRS or a suicidal attempt within the past year, as indicated by the C-SSRS at screening visit; Positive drug screen (amphetamines, opiates, cocaine, barbiturates, phencyclidine) at screening or Visit 1A (if applicable). Participants with positive cannabis and benzodiazepine drug tests can be included if the investigator confirms that there is no active substance related disorder; Participants with a body mass index (weight [kg]/height [m]²) lower than 18 kg/m² or greater than 40 kg/m2 at screening; Further exclusion criteria apply.

EU CTIS 2023-507942-10-00