A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in Pe… (NCT04937829) | Clinical Trial Compass
CompletedPhase 1
A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication
United States59 participantsStarted 2021-07-20
Plain-language summary
This study is open to adults between 18 and 65 years of age who have depression (major depressive disorder). People with a current depressive episode lasting between 2 months and one and a half years can join the study. This study is for people for whom existing treatments for depression do not work sufficiently.
The purpose of this study is to test how well a medicine called BI 1569912 is tolerated and whether it may help people with depression.
It is planned to test 4 different dosages of BI 1569912 in this study. Each participant gets either one BI 1569912 dosage or placebo. It is decided randomly, which means by chance, who gets which treatment. Participants take BI 1569912 or placebo as tablets once during the study. Placebo tablets look like BI 1569912 tablets but do not contain any medicine. Participants also continue taking their usual medicine for depression throughout the study.
Participants are in the study for about 5 weeks. During this time, they visit the study site 4 times, with a stay at the study site for 9 days.
The doctors check the health of the participants and note any health problems that could have been caused by BI 1569912. The participants fill in questionnaires about their depression symptoms.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. 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.
. In the current episode, patients have shown insufficient treatment response (defined by less than 50 % response to one or more antidepressant drugs of adequate dose and treatment duration (according to Summary of Product Characteristics) as evaluated by Antidepressant Treatment Response Questionnaire (ATRQ). 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. Use of bupropion is not allowed.
. Documented ongoing monotherapy treatment of ≥ 6 weeks at randomisation (i.e. Visit 2 day 1) with a protocol specified Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) at adequate dose (according to ATRQ assessment). sampling at Visit 1). Patients who are not on an SSRI at Visit 1 will undergo a lead in phase as described in the Flow Chart. Patients who meet all the eligibility criteria but are not on an SSRI/SNRI at Visit 1, will have the option to undergo a 6 week open label lead in phase with SSRI/SNRI. These patients will be reassessed at Visit 1A to determine eligibility to be randomized to the trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Decrease From Baseline (Peak Decrease) in Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Any Day Within a 7-day Interval
Timeframe: Evaluations taken at baseline (day -63 to -3) and on day 1, 2, 4, 6 and 8 (with trial drug intake on day 1).
2
Number of Patients With Drug-related Adverse Events
Timeframe: The on treatment period + Follow up period, up to 15 days.
. Male or female patients, aged 18 to 65 years at screening. If Women of childbearing potential (WOCBP) are included, they have to be able and willing to use two methods of contraception which include one highly effective method of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 %, plus one additional barrier method. If men who are able to father a child, are willing to participate, they have to use an adequate form of effective contraception for the duration of study participation and for at least 28 days after treatment has ended.
. 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.
Exclusion criteria
. Patient had met diagnostic criteria per Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder or MDD with psychotic features at any time point in the patient's life.
. 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.
. Diagnosis of any other mental disorder (in addition to those as described in Exclusion Criterion #1 and #2) that was the primary focus of treatment within 6 months prior to screening, as per clinical discretion of the investigator.
. Patients with a Body Mass Index (weight \[kg\]/height \[m\]²) lower than 18 kg/m² at screening.
. Diagnosis of a moderate to severe substance-related disorder within the last 6 months before screening visit (with exception of caffeine and tobacco).
. Use of Ketamine/S-Ketamine for the current ongoing depressive episode.
. 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).