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A Phase II, 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 as adjunctive therapy in patients with major depressive disorder

A study to test different doses of BI 1569912 in people with depression who take anti-depressive medicine

Murakami Kanako

IQVIA Services Japan G.K.

4-10-18 Takanawa Minato-ku Tokyo Japan

BI1569912_Japan@iqvia.com

jRCT Inquiry Receipt Center

IQVIA Services Japan G.K.

4-10-18 Takanawa Minato-ku Tokyo Japan

+81-3-6859-9500

BI1569912_Japan@iqvia.com

Recruiting

July. 16, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-Established diagnosis of MDD with a duration of current depressive episode >= 8 weeks at the time of screening visit
-Hamilton Depression Rating Scale 17 - Severity scale score >17
-A documented ongoing monotherapy treatment of >= 6 weeks at the randomization visit, with an SSRI or SNRI at adequate dose
-In the current episode, participants have shown insufficient treatment response
-Male and female participants, 18 to 65 years of age at the time of consent.
-Women who are of childbearing potential must be able and willing, to use two methods of contraception.

- Had 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
- Any other personality disorder 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
- A current or recent history of clinically significant suicidal ideation with intent within the past 3 months or a suicidal attempt within the past year
- Diagnosis of a moderate to severe substance related disorder within 6 months prior to consent (with exception of caffeine and tobacco).
- Positive drug screen (amphetamines, opiates, cocaine, barbiturates, phencyclidine)
- Have started psychotherapy or other non-drug therapies (e.g. acupuncture, hypnosis) within 3 months prior to consent or plan to start at any time during the study
- Use of alternative or traditional medicine (e.g. Chinese traditional medicine, herbal medication, St. John's wort etc.) within 14 days prior to randomization and during the entire course of the study
- Use of NMDA inhibitors (including ketamine/esketamine) for the current ongoing depressive episode or any past treatment failure with ketamine.
- Use of psychotropic medication, outside of ongoing SSRI/SNRI monotherapy and certain exceptions, which was not discontinued at least 5 half-lives prior to randomization.

Both

Major depressive disorder

Drug: BI1569912
Other: Placebo

Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 8

+81-42-648-5551

April. 05, 2024

Yes

Researcheres can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from the clinical trial

USA/China/Germany/Czech Republic/Bulgaria/Belgium