A Phase II, 6-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial With a Quetiapine Arm to Evaluate the Efficacy, Tolerability and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants

  • End date
    Feb 15, 2024
  • participants needed
  • sponsor
    Boehringer Ingelheim
Updated on 24 October 2022


This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study.

Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only.

Participants take BI 1358894, quetiapine, or placebo as tablets twice a day. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine.

Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms.

The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.

Condition Depressive Disorder, Major
Treatment Placebo, Quetiapine, BI 1358894
Clinical Study IdentifierNCT04521478
SponsorBoehringer Ingelheim
Last Modified on24 October 2022


Yes No Not Sure

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 Diagnostic and
Statistical Manual of Mental Disorders, 5th version (DSM-5) (SCID-5), with a duration of
current depressive episode ≥ 8 weeks and ≤ 18 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
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 (computer
administered and rater-administered MADRS)
A documented ongoing monotherapy treatment of ≥ 6 weeks at the screening visit, with a
Able to communicate well, and to understand and comply with trial requirements
protocol specified Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin
Norepinephrine Reuptake Inhibitor (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
Women who are of child-bearing potential (WOCBP)1 must be able and willing to use two
methods of contraception, as confirmed by the investigator. 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
Signed and dated written informed consent in accordance with ICH-GCP and local
legislation prior to admission to the trial

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 Clinical
Trials (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 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)
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