A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280235
• Other study ID #: 1447-0005
• Secondary ID: U1111-1297-31262
• Status: Recruiting
• Phase: Phase 2
• Start date: March 7, 2024
• Est. completion date: October 3, 2025

Study information

• Verified date: May 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: October 3, 2025
• Est. primary completion date: August 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• BI 1569912
BI 1569912
• Placebo
Placebo matching BI 1569912

Locations

Country	Name	City	State
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Chicago Research Center, Incorporated	Chicago	Illinois
United States	CT Clinical Research	Cromwell	Connecticut
United States	Midwest Clinical Research	Dayton	Ohio
United States	iResearch Atlanta	Decatur	Georgia
United States	Galiz Research	Hialeah	Florida
United States	Hassman Research Institute	Marlton	New Jersey
United States	ActivMed Practices & Research	Methuen	Massachusetts
United States	CCM Clinical Research Group, LLC	Miami	Florida
United States	Neuro-Behavioral Clinical Research	North Canton	Ohio
United States	Excell Research Inc.	Oceanside	California
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	NRC Research Institute	Orange	California
United States	Asclepes Research Centers	Panorama City	California
United States	Boston Clinical Trials	Roslindale	Massachusetts
United States	Southwest Biomedical Research, LLC	Tucson	Arizona
United States	Adams Clinical	Watertown	Massachusetts
United States	Grayline Research Center	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 8	The MADRS evaluates core symptoms of depression. It is a clinician-rated measure of depression severity and consists of 10 items. 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.	at baseline, at day 8
Secondary	Change from baseline in MADRS total score at Week 6		at baseline, at week 6
Secondary	Response defined as =50% MADRS reduction from baseline at Day 8		at baseline, at day 8
Secondary	Response defined as =50% MADRS reduction from baseline at Week 6		at baseline, at week 6
Secondary	Remission defined as MADRS total score =10 at Week 6		up to 6 weeks
Secondary	Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8	The SMDDS is a 16-item, patient-reported outcome (PRO) measure developed to capture the core symptoms of major depressive disorder (MDD).; 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.; It is calculated by creating first a single score for items 11 and 12 by selecting the highest severity on either item, and then creating the sum of the 15 responses.	at baseline, at day 8
Secondary	Change from baseline in SMDDS total score at Week 4		at baseline, at week 4

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