A study to test the effect of different doses of BI 1358894 andquetiapine in people with depression.

Phase 1

Conditions: Depressive Disorder
MedDRA version: 20.0Level: HLTClassification code 10012401Term: Depressive disordersSystem Organ Class: 100000004873
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2019-004264-21-SK

Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 431

Inclusion Criteria

- Established diagnosis of Major Depressive Disorder (MDD), single episode or recurrent, as confirmed at the time of screening by the Structured Clinical Interview for DSM-5 (SCID-5), with a duration of current depressive episode = 8 weeks and = 24 months at the
time of screening visit.
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score = 24 at screening, as confirmed by a trained site based rater AND interactive,
computer administered MADRS. The difference in the rater and computer administered MADRS must not exceed more than 7 points (for details
refer to section 6.2). In addition, trial participants must have a score of = 3 on the Reported Sadness Item on both MADRS scales (computeradministered and rater-administered MADRS).
- A documented ongoing monotherapy treatment of = 4 weeks at the screening visit, with a protocol specified SSRI or SNRI or bupropion at adequate dose (at least minimum effective dose as per prescribing information and as confirmed per detectable drug levels in the screening blood sampling).
- Male and female participants, 18 to 65 years of age, both inclusively at the time of consent.
- Women of childbearing potential (WOCBP) able and willing to use two methods of contraception, confirmed by the investigator
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 409
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

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 SCID-5 at the time of screening.
- Diagnosis of any other mental disorder (in addition to those described above)that was 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 more than 2 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).
- Have received electroconvulsive therapy and/or administration of Ketamine /S-Ketamine for the current ongoing depressive episode and/or transcranial magnetic stimulation (TMS) for the current ongoing depressive episode or within 12 months prior to screening.
- Have a lifetime history of vagal nerve stimulation or psychosurgery.
- Further criteria apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary trial objectives are to demonstrate a non-flat dose response curve, to evaluate the<br>dose response relationship, and to assess the treatment effect size.;Secondary Objective: Not applicable;Primary end point(s): 1) Change from baseline in MADRS total score;Timepoint(s) of evaluation of this end point: 1) Week 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Response defined as = 50% MADRS reduction from baseline <br>2) Change from baseline in STAI State and Trait version scores<br>3) Change from baseline in Clinical Global Impression Severity Scale (CGI-S) score<br>4) Change from baseline in SMDDS total score;Timepoint(s) of evaluation of this end point: 1) Week 6<br>2) Week 6<br>3) Week 6<br>4) Week 6<br><br>

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