UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder: A Prospective, Open-Label Trial
Title of the study (Brief title)	Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
Region	Japan

Condition
Condition	treatment-resistant depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Tsuyoshi Miyaoka
Organization	Shimane University School of Medicine
Division name	Department of Psychiatry,
Address	89-1 Enyacho, Izumo 693-8501
TEL	853-20-2262
Email	miyanyan@med.shimane-u.ac.jp

Public contact
Name of contact person	Tsuyoshi Miyaoka
Organization	Shimane University School of Medicine
Division name	Department of Psychiatry
Address	89-1 Enyacho, Izumo 693-8501
TEL	853-20-2262
Homepage URL
Email	miyanyan@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University School of Medicine
Institute
Department

Funding Source
Organization	no grant
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	島根大学医学部

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 23 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2018 Year 12 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 23 Day
Last modified on	2017 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032439