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

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

59 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new medicine called BI 1569912 for adults with depression who haven't improved with other treatments. Participants will take either the medicine or another substance while continuing their usual medication. The study will check if BI 1569912 helps reduce depression symptoms and is safe to use.

Will I have to stop taking my current medications?

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

Eligibility Criteria

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

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

Treatment Details

Interventions

• BI 1569912
• Placebo

Participant Groups

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+