Clinical trial NCT06558344: A Study to Test Different Doses of BI 1569912 in People With Depression
Official title: A 6-week, Multi-centre, Randomised, Double-blind (Participant and Investigator), Placebo-controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is open to adults between 18 and 65 years of age with a type of depression called major depressive disorder. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression.

Participants are put into 4 groups randomly, which means by chance. Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks.

Participants are in the study for about 2.5 months. During this time, they visit the study site at least 7 times. At the visits, doctors and their staff ask participants about their depression symptoms. At the end of the study, the results are compared between the groups to see whether the treatment works. The doctors also regularly check the general health of participants and take note of any unwanted effects.


Eligibility criteria: Inclusion criteria

* Male and female participants, 18 to 65 years of age, both inclusively at the time of consent
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Women of childbearing potential (WOCBP) must be ready and able to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly plus one additional barrier method. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
* Established diagnosis of Major depressive disorder (MDD), single episode or recurrent, as confirmed at the time of screening by the Mini-International Neuropsychiatric Interview (MINI) with a duration of the current depressive episode ≥8 weeks AND ≤24 months at the time of randomisation
* Hamilton Depression Rating Scale-17 (HDRS-17) - Severity scale score ≥20
* Clinical Global Impression- Severity Scale (CGI-S) score ≥4

Exclusion criteria:

* Per Mini International Neuropsychiatric Interview (MINI), have ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder
* Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder, or MDD with psychotic features as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (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 any other mental disorder that was the primary focus of treatment within 6 months prior to screening (as per clinical discretion of the investigator)
* Treatment failure to 2 or more antidepressants in the current episode, defined as less than 50% response to treatments administered at an adequate dose and duration as evaluated by the Antidepressant treatment response questionnaire (ATRQ)
* History or presence (upon clinical examination) of seizure disorders or an increased risk of seizures (first degree relative with epilepsy), stroke, brain tumour, or any other major neurological illness that could impact participation in the trial
* A current or recent history of clinically significant suicidal ideation with intent within the past 3 months, corresponding to a score of 4 or 5 for ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS) or a suicidal attempt within the past year, as indicated by the C-SSRS at screening visit
* Participants with a body mass index (weight \[kg\]/height \[m\]²) lower than 18 kg/m² or greater than 40 kg/m2 at screening
* Diagnosis of a moderate to severe substance related disorder as defined by DSM-5 criteria within 6 months prior to screening visit (with exception of caffeine and tobacco) Further exclusion criteria apply.

Primary outcomes:
measure: Change from baseline in MADRS total score at Week 6
timeFrame: at baseline and at Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Bellflower
country: United States
facility: Clinical Innovations, Inc
state: California
city: Long Beach
country: United States
facility: ASCLEPES Research Centers, P.C. dba Alliance Research
state: California
city: Oceanside
country: United States
facility: Excell Research Inc.
state: California
city: Riverside
country: United States
facility: CiTrials-Riverside-63180
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research, LLC
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group LLC
state: California
city: Hollywood
country: United States
facility: Research Centers of America-Hollywood-67537
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc-Jacksonville-62642
state: Florida
city: Miami
country: United States
facility: CCM Clinical Research Group, LLC-Miami-68482
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation-Miami-69452
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc-Orlando-62685
state: Florida
city: Atlanta
country: United States
facility: Advanced Discovery Research LLC
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Marietta
country: United States
facility: Psych Atlanta, PC
state: Georgia
city: Baltimore
country: United States
facility: Pharmasite Research, Incorporated
state: Maryland
city: Boston
country: United States
facility: Copley Clinical
state: Massachusetts
city: Roslindale
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Portsmouth
country: United States
facility: ActivMed
state: New Hampshire
city: Cherry Hill
country: United States
facility: Center For Emotional Fitness
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Bronx
country: United States
facility: Davis Clinical
state: New York
city: Brooklyn
country: United States
facility: Integrative Clinical Trials LLC
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: New York
country: United States
facility: Berman Clinical
state: New York
city: Oklahoma City
country: United States
facility: Sooner Clinical Research, Inc
state: Oklahoma
city: Media
country: United States
facility: Surburban Research Associates, Inc.
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc-Memphis-65988
state: Tennessee
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
city: Fukuoka, Chikugo
country: Japan
facility: Uematsu Mental Clinic
city: Fukuoka, Fukuoka
country: Japan
facility: Kaku Mental Clinic
city: Fukuoka, Kurume
country: Japan
facility: Hirota Clinic
city: Kanagawa,Sagamihara
country: Japan
facility: Yutaka Clinic
city: Tokyo, Shibuya-ku
country: Japan
facility: Maynds Tower Mental Clinic
city: Tokyo, Shinjuku-ku
country: Japan
facility: Ichigaya Himorogi Clinic
Study officials:
References: