A Home-based Study Using Mobile Technology to Test Whether BI 1358894 is Effective in People With Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: BI 1358894; Placebo
Intervention description: 125 milligram (mg) BI 1358894 taken orally as three film-coated tablets (1x 25mg and 2x 50mg) once a day in the morning for six weeks.; Placebo matching BI 1358894 taken orally as three film-coated tablets once a day in the morning for six weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a home-based study in adults with depression. People who have been diagnosed with
      Major Depressive Disorder can participate in the study. Participants can take part if they
      are being treated for their depression but still have symptoms. The purpose of this study is
      to find out whether a medicine called BI 1358894 helps people with depression.

      Participants are in the study for about 2 months and do not need to visit a study site during
      this time. All study visits are conducted at participant's home by a mobile study nurse, by
      videoconference, and by phone calls. Participants are put into 2 groups by chance. One group
      takes BI 1358894 tablets. The other group takes placebo tablets. Placebo tablets look like BI
      1358894 tablets but do not contain any medicine.

      The participants answer questions about the symptoms of their depression. We then compare the
      results between the BI 1358894 and placebo groups. The doctors and nurses also regularly
      check the general health of the participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of Major Depressive Disorder, single episode or recurrent, as
             confirmed at the time of screening by the Structured Clinical Interview for Diagnostic
             and Statistical Manual of Mental Disorders v5 (DSM-5, SCID-5), with a duration of
             current depressive episode ≥ 8 weeks and ≤ 12 months at the time of screening visit.

          -  Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 22 at screening, as
             confirmed by a trained rater. In addition, trial participants must have a score of ≥ 3
             on the Reported Sadness item on MADRS.

          -  A documented ongoing monotherapy treatment of ≥ 8 weeks at the screening visit, with a
             protocol specified SSRI or SNRI (refer to the ISF) at adequate dose (at least minimum
             effective dose as per prescribing information and as confirmed per detectable drug
             levels in the screening blood or urine sampling).

          -  Male and female participants, 18 to 65 years of age, both inclusively at the time of
             consent.

          -  Women of child-bearing potential (WOCBP)2 able and willing to use two methods of
             contraception, which include one highly effective method of birth control per ICH M3
             (R2) that results in a low failure rate of less than 1%, plus one barrier method.

          -  Signed and dated written informed consent in accordance with ICH-GCP and local
             legislation prior to admission to the trial.

          -  Able to communicate well, and to understand and comply with trial requirements.

        Exclusion Criteria:

          -  Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective
             disorder, schizophreniform disorder, bipolar disorder, delusional disorder or MDD with
             psychotic features as assessed by the Structured Clinical Interview for DSM -5
             (SCID-5) at the time of screening.

          -  Diagnosis of any other mental disorder (in addition to those as described in Exclusion
             Criterion #1) that was the primary focus of treatment within 6 months prior to
             screening or at baseline (as per clinical discretion of the investigator).

          -  Diagnosis with antisocial, paranoid, schizoid or schizotypal 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 likely to
             impact trial participation, as per the judgement of investigator.

          -  Diagnosis of a substance related disorder within 3 months prior to screening visit
             (with exception of caffeine and tobacco).

          -  History of seizure disorders, stroke, brain tumor or any other major neurological
             illness that can impact participation in the trial.

          -  History of 4 or more unsuccessful monotherapy treatments (at adequate dosage and
             duration, per local prescribing information of the product) with an approved
             antidepressant medication for the current ongoing major depressive episode. These
             include ongoing monotherapy treatment with a protocol specified SSRI or SNRI as
             described in Inclusion Criterion #3.

          -  Any suicidal behavior in the past 12 months prior to screening (per investigator
             judgement including an actual attempt, interrupted attempt, aborted attempt, or
             preparatory acts or behaviour).

          -  Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale
             (CSSRS) in the past 3 months prior to screening or at screening or baseline visit
             (i.e. active suicidal thought with method and intent but without specific plan, or
             active suicidal thought with method, intent and plan).

          -  Further exclusion criteria apply