A research study to find out if MIJ821 (the study treatment) on top of standard antidepressant medication(s) is effective and safe (can help people who suffer from major depressive disorder and have not responded to at least 2 different antidepressant treatments).

JRCT ID: jRCT2031220655

Registered date:23/02/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: treatment- resistant depression (TRD)
• Date of first enrollment: 10/05/2023
• Target sample size: 8
• Countries of recruitment: United States,Japan,Spain,Japan,Poland,Japan
• Study type: Interventional

Intervention(s)

single injection of Study Drug in addition to standard of care (SoC)
Drug: MIJ821 Subcutaneous Injection - low dose
Drug: MIJ821 Subcutaneous Injection - medium dose
Drug: MIJ821 Subcutaneous Injection - high dose
Drug: Placebo Subcutaneous Injection

Outcome(s)

• Primary Outcome: MADRS total score at 24 hours after s.c. injection compared to baseline assessment

Key inclusion & exclusion criteria

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

Include criteria

- Signed informed consent must be obtained prior to participation in the study.
- Male and female participants, 18 to 65 years of age (inclusive) at screening.
- DSM-5 defined major depressive disorder (MDD) and a current major depressive episode (MDE)
MADRS score >= 24
- Failure to respond to 2 or more antidepressant treatments where the two failed treatments are two different antidepressants

Exclude criteria

- Any prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder
- Participants with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or participants who went through detoxification treatment within 1 month before Screening.
- Participants with current borderline personality disorder or antisocial personality disorder
- Current clinical diagnosis of autism, dementia, or intellectual disability.

Related Information

• Primary Sponsor: Iwasaki Ryohei
• Secondary ID(s): NCT05454410