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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04521478




Registration number
NCT04521478
Ethics application status
Date submitted
18/08/2020
Date registered
20/08/2020
Date last updated
19/03/2024

Titles & IDs
Public title
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
Scientific title
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.
Secondary ID [1] 0 0
2019-004264-21
Secondary ID [2] 0 0
1402-0011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Major 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 1358894
Treatment: Drugs - Placebo
Treatment: Drugs - Quetiapine

Experimental: Treatment group 1 - BI 1358894

Placebo Comparator: Placebo group - Placebo

Experimental: Treatment group 2 - Quetiapine


Treatment: Drugs: BI 1358894
BI 1358894

Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: Quetiapine
quetiapine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Timepoint [1] 0 0
At week 6
Secondary outcome [1] 0 0
Response defined as = 50% MADRS reduction from baseline
Timepoint [1] 0 0
At week 6
Secondary outcome [2] 0 0
Change from baseline in State-Trait Anxiety Inventory (STAI) State and Trait version scores
Timepoint [2] 0 0
At week 6
Secondary outcome [3] 0 0
Change from baseline in Clinical Global Impression Severity Scale (CGI-S) score
Timepoint [3] 0 0
At week 6
Secondary outcome [4] 0 0
Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score
Timepoint [4] 0 0
At week 6

Eligibility
Key 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 = 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 (computer
administered and rater-administered MADRS)

- A documented ongoing monotherapy treatment of = 4 weeks at the screening visit, with
bupropion or a 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
consent

- Women who are of child-bearing potential (WOCBP)1 must be able and willing, as
confirmed by the investigator, to use two methods of contraception 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

- Able to communicate well, and to understand and comply with trial requirements
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 bupropion or 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/02/2024
Sample size
Target
Accrual to date
Final
389
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Griffith Health - Southport
Recruitment hospital [2] 0 0
Peninsula Therapeutic and Research Group - Frankston
Recruitment hospital [3] 0 0
Albert Road Clinic - Melbourne
Recruitment hospital [4] 0 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
4125 - Southport
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Kansas
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Mississippi
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Missouri
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New Jersey
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New York
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Ohio
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Pennsylvania
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United States of America
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Washington
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Argentina
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Caba
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Argentina
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Cordoba
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Argentina
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La Plata
Country [19] 0 0
Argentina
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Rosario
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Bulgaria
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Burgas
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Bulgaria
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Plovdiv
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Bulgaria
State/province [22] 0 0
Sofia
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Canada
State/province [23] 0 0
Alberta
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Canada
State/province [24] 0 0
British Columbia
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Canada
State/province [25] 0 0
Ontario
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Czechia
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Hradec Kralove
Country [27] 0 0
Czechia
State/province [27] 0 0
Kladno
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Czechia
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Ostrava-Poruba
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Czechia
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Plzen
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Czechia
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Prague
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France
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Dijon
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France
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Douai
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France
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Elancourt
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France
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Montpellier
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France
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Nantes
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France
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Nice
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France
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Nîmes
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France
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Saint-Cyr-sur-Loire
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France
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Toulouse
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Germany
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Bad Homburg
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Germany
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Frankfurt am Main
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Stralsund
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Germany
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Westerstede
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Hungary
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Budapest
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Hungary
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Gyongyos
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Japan
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Chiba, Ichikawa
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Japan
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Fukuoka, Fukuoka
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Japan
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Hokkaido, Sapporo
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Japan
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Hyogo, Amagasaki
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Japan
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Hyogo, Kobe
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Japan
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Kanagawa, Kawasaki
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Japan
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Kanagawa,Sagamihara
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Japan
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Kumamoto, Kumamoto
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Japan
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Nagasaki, Nagasaki
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Japan
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Nara, Kashihara
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Japan
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Saga, Karatsu
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Japan
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Saga, Tosu
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Japan
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Tokyo, Kodaira
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Japan
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Tokyo, Minato-ku
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Japan
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Tokyo, Setagaya-ku
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Japan
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Tokyo, Shibuya-ku
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Japan
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Tokyo, Shinjuku-ku
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Japan
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Tokyo, Toshima-ku
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Poland
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Gdansk
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Poznan
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Russian Federation
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Moscow
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Svidnik
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Slovakia
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Trencin
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Slovakia
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Vranov nad Toplou
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Spain
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Alcorcón
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Spain
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Barcelona
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Spain
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Jerez de la Frontera
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Spain
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Madrid
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Spain
State/province [84] 0 0
Salamanca

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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. Placebo tablets look like BI
1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets
twice a day. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04521478
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04521478