Depressive Disorder MedDRA version: 20.0 Level: HLT Classification code 10012401 Term: Depressive disorders System Organ Class: 100000004873
Conditions
Interventions
Product Name: BI 1358894
Product Code: BI 1358894
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: N.A.
Current Sponsor code: BI 1358894
Other descriptive name: BI 1358894
Concentration un
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
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 or urine 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary trial objectives are to demonstrate a non-flat dose response curve, to evaluate the 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 at Week 6;Timepoint(s) of evaluation of this end point: 1) Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Response defined as = 50% MADRS reduction from baseline at Week 6 2) Change from baseline in STAI State and Trait version scores at Week 6 3) Change from baseline in Clinical Global Impression Severity Scale (CGI-S) score at Week 6 4) Change from baseline in SMDDS total score at Week 6;Timepoint(s) of evaluation of this end point: 1) Week 6 2) Week 6 3) Week 6 4) Week 6 | — |
Countries
Argentina, Australia, Bulgaria, Canada, Czechia, Czech Republic, France, Germany, Hungary, Japan, Netherlands, Poland, Russian Federation, Slovakia, Spain, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed