BridgeMD
A study to test different doses of BI 1569912 in people with depression who take anti-depressive medicine
EU CTIS ID: 2023-507942-10-00
What this study is testing
The primary trial objectives are to demonstrate a [...], to evaluate the dose response relationship, and to assess the quantitative treatment effect size.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
- 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).
- 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.
- Participants with a body mass index (weight [kg]/height [m]²) lower than 18 kg/m² or greater than 40 kg/m2 at screening.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
- 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).
- 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.
- Participants with a body mass index (weight [kg]/height [m]²) lower than 18 kg/m² or greater than 40 kg/m2 at screening.
- Diagnosis of a moderate to severe substance related disorder within 6 months prior to screening visit (with exception of caffeine and tobacco).
- 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.
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- China
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; China; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.