UMIN-CTR Clinical Trial

Public title

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

Acronym

Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder

Scientific Title

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

Scientific Title:Acronym

Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder

Region

Japan

Condition

treatment-resistant depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We performed a prospective study to evaluate the effects of Clostridium butyricum MIYAIRI (CBM588)for treatment-resistant depression

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Clostridium butyricum MIYAIRI (CBM588)

Interventions/Control_2

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

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key 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.

Key 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.

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Tsuyoshi Miyaoka

Organization

Shimane University School of Medicine

Division name

Department of Psychiatry,

Zip code

Address

89-1 Enyacho, Izumo 693-8501

TEL

853-20-2262

Email

miyanyan@med.shimane-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tsuyoshi Miyaoka

Organization

Shimane University School of Medicine

Division name

Department of Psychiatry

Zip code

Address

89-1 Enyacho, Izumo 693-8501

TEL

853-20-2262

Homepage URL

Email

miyanyan@med.shimane-u.ac.jp

Institute

Shimane University School of Medicine

Institute

Department

Personal name

Organization

no grant

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

島根大学医学部

Date of disclosure of the study information

2019

Year

07

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Suspended

Date of protocol fixation

2018

Year

12

Month

15

Day

Date of IRB

Anticipated trial start date

2019

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

07

Month

23

Day

Last modified on

2017

Year

07

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032439