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

JRCT ID: jRCT2031240035

Registered date:16/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Major depressive disorder
• Date of first enrollment: 16/07/2024
• Target sample size: 24
• Countries of recruitment: USA,Japan,China,Japan,Germany,Japan,Czech Republic,Japan,Bulgaria,Japan,Belgium,Japan
• Study type: Interventional

Intervention(s)

Drug: BI1569912
Other: Placebo

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

-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.

Exclude criteria

- 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.

Related Information

• Primary Sponsor: Takekawa Shigeru