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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
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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.
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Secondary ID [1]
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2019-004264-21
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Secondary ID [2]
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1402-0011
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Major
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
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Assessment method [1]
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The MADRS consists of 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thought, suicidal thoughts. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). The possible total score could range from 0 to 60 (from normal with absence of symptoms to severe depression).
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Timepoint [1]
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At week 6
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Secondary outcome [1]
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Response defined as = 50% MADRS reduction from baseline
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Assessment method [1]
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Timepoint [1]
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At week 6
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Secondary outcome [2]
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Change from baseline in State-Trait Anxiety Inventory (STAI) State and Trait version scores
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Assessment method [2]
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The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel "right now, at this moment." The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how people generally feel. Each STAI item is given a weighted score of 1 to 4. A rating of 4 indicates the presence of a high level of anxiety for ten S-Anxiety items and eleven T-Anxiety items (e.g., "I feel frightened," "I feel upset"). A high rating indicates the absence of anxiety for the remaining ten S-Anxiety items and nine T-Anxiety items (e.g., "I feel calm," "I feel relaxed").Scores for both the S-Anxiety and the T-Anxiety scales can vary from a minimum of 20 to a maximum of 80. Higher scores indicate greater anxiety.
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Timepoint [2]
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At week 6
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Secondary outcome [3]
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Change from baseline in Clinical Global Impression Severity Scale (CGI-S) score
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Assessment method [3]
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The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience with the depression population, a participant is assessed on severity of illness at the time of rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. Higher scores indicate worsening.
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Timepoint [3]
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At week 6
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Secondary outcome [4]
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Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score
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Assessment method [4]
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The different categories and associated 16 items are: Negative Emotions/Mood: sadness, hopeless/helpless, irritability, anhedonia; Anxiety: feeling overwhelmed, worry; Low Energy: tiredness; Cognition: intrusive thoughts, poor concentration; Sleep Disturbances: general sleep adequacy; Self Harm/Suicide: life not worth living; Low Motivation: lack of drive, no interest in activities; Sense of Self: self-blame; Eating Behavior: poor appetite, overeating. The SMDDS uses a recall of "over the past 7 days" and participants respond to each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"). The total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology.
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Timepoint [4]
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At week 6
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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
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/11/2020
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
2/02/2024
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Sample size
Target
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Accrual to date
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Final
389
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Griffith Health - Southport
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Recruitment hospital [2]
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Peninsula Therapeutic and Research Group - Frankston
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Recruitment hospital [3]
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Albert Road Clinic - Melbourne
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Recruitment hospital [4]
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Monash Alfred Psychiatry Research Centre - Melbourne
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Recruitment postcode(s) [1]
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4125 - Southport
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
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Trencin
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Vranov nad Toplou
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Madrid
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Salamanca
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Funding & Sponsors
Primary sponsor type
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Name
Boehringer Ingelheim
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04521478
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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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'.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
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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