Clinical trial NCT06280235: A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine
Official title: A Phase II, 6-week, Multicenter, Randomized, Double Blind (Patient and Investigator) or Masked, Placebo Controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 as Adjunctive Therapy in MD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 84
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 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression.

Participants continue their standard therapy throughout the study.

Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 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 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms.

The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants.


Eligibility criteria: Inclusion criteria:

1. Male and female participants, 18 to 65 years of age, both inclusively at the time of consent.
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. 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 and in the study protocol.
4. 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 current depressive episode ≥8 weeks at the time of screening visit.
5. Hamilton Depression Rating Scale-17 (HDRS-17) - Severity scale score \>17.
6. A documented ongoing monotherapy treatment of ≥6 weeks at the randomisation visit, with an selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) specified in the investigator site file (ISF) at adequate dose (at least minimum effective dose as per prescribing information).

   * The participant must adhere to the screening visit dose of the background SSRI/SNRI until the end of the trial. Participants should be on a stable dose for at least 4 weeks prior to randomisation.
   * Participants, who, in addition to their monotherapy with an SSRI/SNRI, are taking additional low dose antidepressant medications for purposes other than treating depressive symptoms, are not excluded. The dose must be less than the lowest dose indicated for MDD.
7. In the current episode, participants have shown insufficient treatment response defined by less than 50% response to a maximum of 4 antidepressant treatments of adequate dose and treatment duration (according to Summary of Product Characteristics) as evaluated by the antidepressant treatment response questionnaire (ATRQ).

Exclusion criteria:

1. Per MINI, have ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder.
2. 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.
3. 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).
4. 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.
5. 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.
6. Participants with a body mass index (weight \[kg\]/height \[m\]²) lower than 18 kg/m² or greater than 40 kg/m² at screening.
7. Diagnosis of a moderate to severe substance related disorder within 6 months prior to screening visit (with exception of caffeine and tobacco).
8. Positive drug screen (amphetamines, opiates, cocaine, barbiturates, phencyclidine) at screening or Visit 1A (if applicable). Participants with positive cannabis and benzodiazepine drug tests can be included if the investigator confirms that there is no active substance related disorder. Further exclusion criteria apply.

Primary outcomes:
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
timeFrame: at baseline, at week 6
Secondary outcomes:
measure: Change from baseline in MADRS total score at Day 8
timeFrame: at baseline, at day 8
measure: Response defined as ≥50% MADRS reduction from baseline at Day 8
timeFrame: at baseline, at day 8
measure: Response defined as ≥50% MADRS reduction from baseline at Week 6
timeFrame: at baseline, at week 6
measure: Remission defined as MADRS total score ≤10 at Week 6
timeFrame: up to 6 weeks
measure: Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8
timeFrame: at baseline, at day 8
measure: Change from baseline in SMDDS total score at Week 4
timeFrame: at baseline, at week 4
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southwest Biomedical Research, LLC
state: Arizona
city: Oceanside
country: United States
facility: Excell Research Inc.
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Panorama City
country: United States
facility: Asclepes Research Centers-Panorama City-62905
state: California
city: Cromwell
country: United States
facility: CT Clinical Research
state: Connecticut
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: CCM Clinical Research Group, LLC-Miami-68482
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center, Incorporated
state: Illinois
city: Methuen
country: United States
facility: ActivMed Practices & Research
state: Massachusetts
city: Roslindale
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: Marlton
country: United States
facility: Hassman Research Institute-Marlton-66897
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Bellaire
country: United States
facility: Houston Clinical Trials, LLC
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: Alken
country: Belgium
facility: Anima Research Center
city: Duffel
country: Belgium
facility: Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
city: Cherven Bryag
country: Bulgaria
facility: Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
city: Rousse
country: Bulgaria
facility: MHC - Ruse, EOOD
city: Sofia
country: Bulgaria
facility: Medical Center "Sv.Naum"
city: Sofia
country: Bulgaria
facility: DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan" OOD
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Intermedica Ltd.
city: Varna
country: Bulgaria
facility: DCC Mladost-M Varna OOD
city: Baoding
country: China
facility: Hebei Mental Health Center
city: Beijing
country: China
facility: Beijing Anding Hospital
city: Beijing
country: China
facility: Peking University Sixth Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital Of Central South University
city: Shanghai
country: China
facility: Shanghai Mental Health Center
city: Shenzhen
country: China
facility: Shenzhen Kangning Hospital
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Tianjin
country: China
facility: Tianjin Anding Hospital
city: Plzen
country: Czechia
facility: A-SHINE s.r.o
city: Praha
country: Czechia
facility: Clintrial s.r.o.
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin KöR
city: Schwerin
country: Germany
facility: Somni Bene - Institut für Medizinische Forschung & Schlafmedizin Schwerin GmbH
city: Anan-shi
country: Japan
facility: Iwaki Clinic, Tokushima, Psychosomatic Medicine
city: Fukuoka, Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka-shi
country: Japan
facility: Aisakura Clinic
city: Fukuoka-shi
country: Japan
facility: Kaku Mental Clinic
city: Fukuoka-shi
country: Japan
facility: Mental Clinic Sakurazaka
city: Fukuoka-shi
country: Japan
facility: Kuramitsu Hospital
city: Karatsu-shi
country: Japan
facility: Rainbow and Sea Hospital
city: Kurume-shi
country: Japan
facility: Hirota Clinic
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
city: Shibuya-ku
country: Japan
facility: Maynds Tower Mental Clinic
Study officials:
References: