Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder: A Prospective, Open-Label Trial

Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder: A Prospective, Open-Label Trial - Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028341

Enrollment

Registered

2019-07-23

Start date

2019-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

treatment-resistant depression

Interventions

Clostridium butyricum MIYAIRI (CBM588) This study was a 8-week, prospective open-label evaluation of CBM588 (60 mg/day) in patients with TRD.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Twenty patients experiencing symptom of TRD were enrolled in this study according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) (American Psychiatry Association 2000). TRD was based on chart reviews and defined as an inadequate or nonresponse to 2 or more 8-week trials with 2 different classes of antidepressants. For at least 3 of these 8 weeks, doses were required to be at or near the highest recommended therapeutic dose. Patients with a 17-item Hamiliton Rating Scale Depression (HAMD-17) (Zheng et al., 1988) total score of 16 or greater at the end of screening phase were eligible to participate in this study.

Exclusion criteria

Exclusion criteria: Patients were excluded if they met criteria for an Axis I diagnosis of delirium, dementia or other cognitive disorder, bipolar disorder, schizophrenia or other psychotic disorder, or a clinically significant Axis II diagnosis of obsessive-compulsive, schizoid, schizotypal, paranoid, antisocial, or histrionic personality disorder. Patients were also excluded if they acknowledged substance abuse or dependence within the past 6 months, or if they were pregnant, were nursing, or posed a significant risk of suicide during the study period. Patients with chronic deteriorating illnesses such as diabetes, HIV, and seizure disorders were also excluded.

Design outcomes

Primary

Measure	Time frame
The primary end point was the change from baseline in the Hamilton Depression Rating Scale (HAM-D-17) score from baseline to week 8.	—

Secondary

Measure	Time frame
Secondary end points were changes in Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI) Scale scores from baseline to week 8.	—

Countries

Japan

Contacts

Public ContactTsuyoshi Miyaoka

Shimane University School of Medicine Department of Psychiatry

miyanyan@med.shimane-u.ac.jp853-20-2262

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026