A study to test different doses of BI 1569912 in people with depression

JRCT ID: jRCT2061240061

Registered date:03/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Major Depressive Disorder
• Date of first enrollment: 08/11/2024
• Target sample size: 222
• Countries of recruitment: United States,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 Week 6

Key inclusion & exclusion criteria

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

Include criteria

1) Male and female participants, 18 to 65 years of age
2) Women who are of childbearing potential (WOCBP) must be able and willing, to use two methods of contraception
3) Established diagnosis of MDD, single episode or recurrent with a duration of current depressive episode more than equal to 8 weeks and less than equal to 24 months at the time of randomisation
4) Hamilton Depression Rating Scale 17 (HDRS 17) - Severity score 20 and over
5) Clinical Global Impression Severity Scale (CGI S) score 4 and over

Exclude criteria

1) 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 at the time of screening visit. Any other personality disorder 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) Treatment failure to 2 or more antidepressants in the current episode
5) 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
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) Frequent use of benzodiazepines
9) Positive drug screen (amphetamines, opiates, cocaine, barbiturates, phencyclidine) at screening. Participants with positive cannabis and benzodiazepine tests can be included if the investigator confirms that there is no moderate to severe substance related disorder or chronic benzodiazepine use
10) Have started psychotherapy or other non drug therapies (e.g. acupuncture, hypnosis) within 3 months prior to screening or plan to start at any time during the study
11) Use of NMDA inhibitors (including ketamine / esketamine) for the current ongoing depressive episode or any past treatment failure with ketamine
12) Use of psychotropic medication (including antidepressant and antipsychotic therapy) which was not discontinued at least 5 half lives prior to randomization
13) Prior use of any investigational product within 6 months prior to randomization
14) Have failed a 3rd party eligibility assessment within the 6 months prior screening
15) Known history of HIV infection and/or a positive result for an active Hepatitis B or C infection

Related Information

• Primary Sponsor: Taguchi Aya
• Secondary ID(s): NCT06558344