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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04521478
Ethics application status
Date submitted
18/08/2020
Date registered
20/08/2020

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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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Georgia
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United States of America
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Illinois
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Kansas
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United States of America
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Mississippi
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United States of America
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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
State/province [16] 0 0
Caba
Country [17] 0 0
Argentina
State/province [17] 0 0
Cordoba
Country [18] 0 0
Argentina
State/province [18] 0 0
La Plata
Country [19] 0 0
Argentina
State/province [19] 0 0
Rosario
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Burgas
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Plovdiv
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Sofia
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Czechia
State/province [26] 0 0
Hradec Kralove
Country [27] 0 0
Czechia
State/province [27] 0 0
Kladno
Country [28] 0 0
Czechia
State/province [28] 0 0
Ostrava-Poruba
Country [29] 0 0
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
State/province [69] 0 0
Poznan
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Moscow
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Saratov
Country [72] 0 0
Russian Federation
State/province [72] 0 0
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
Country [78] 0 0
Slovakia
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Trencin
Country [79] 0 0
Slovakia
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Vranov nad Toplou
Country [80] 0 0
Spain
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Alcorcón
Country [81] 0 0
Spain
State/province [81] 0 0
Barcelona
Country [82] 0 0
Spain
State/province [82] 0 0
Jerez de la Frontera
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04521478