Clostridium butyricum MIYAIRI 588 as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder: A Prospective Open-Label Trial

Clinical Neuropharmacology - Tập 41 Số 5 - Trang 151-155 - 2018
Tsuyoshi Miyaoka1,2,3,4, Misako Kanayama1,2,3,4, Rei Wake1,2,3,4, Sadayuki Hashioka1,2,3,4, Maiko Hayashida1,2,3,4, Michiharu Nagahama1,2,3,4, Shihoh Okazaki1,2,3,4, Satoko Yamashita1,2,3,4, Shingo Miura1,2,3,4, Hiroyuki Miki1,2,3,4, Takuji Ohigashi1,2,3,4, Masahiro Koike1,2,3,4, Muneto Izuhara1,2,3,4, Tomoko Araki1,2,3,4, Keiko Tsuchie1,2,3,4, Ilhamuddin Abdul Azis1,2,3,4, Ryosuke Arauchi1,2,3,4, Rostia Arianna Abdullah1,2,3,4, Arata Oh‐Nishi1,2,3,4, Jun Horiguchi1,2,3,4
1Conflicts of Interest and Source of Funding: The authors have no conflicts of interest to declare.
2Department of Psychiatry, Shimane University School of Medicine, Izumo, Japan
3e-mail: [email protected]
4This trial was registered with UMIN (number 000028341).

Tóm tắt

Aim

Up to 60% of depressed patients do not obtain sufficient relief from a course of antidepressant therapy, and these treatment-resistant major depressive disorder (TRD) patients are at increased risk for relapse, chronicity, persistent psychosocial impairments, and suicide. Probiotics actively participate in treatment of neuropsychiatric disorders. However, the role of gut microbiota in brain disorders and depression remains unclear. We performed a prospective study to evaluate the effects of Clostridium butyricum MIYAIRI 588 (CBM588).

 Methods

This was an 8-week open-label study to evaluate the efficacy and safety of CBM588 in combination with antidepressants in adult patients diagnosed with TRD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Forty antidepressant-treated inpatients were included. Patients were randomized to adjuvant treatment with CBM588 (n = 20) or control (n = 20). The primary endpoint was the change in the 17-item Hamilton Depression Rating Scale score from baseline to week 8. Secondary end points were changes in the Beck Depression Inventory and the Beck Anxiety Inventory scale scores from baseline to week 8. The Systematic Assessment of Treatment Emergent Events—General Inquiry was used to assess adverse effects.

 Results

CBM588 (60 mg/d) in combination with antidepressants (flvoxamine, paroxetine, escitalopram, duroxetine, and sertraline) provided significant improvement in depression. All patients completed the trial, and 70% responded to treatment; the remission rate was 35.0%. No serious adverse events occurred.

 Conclusions

These preliminary data suggest that CBM588 in combination with antidepressants is effective and well tolerated in the treatment of TRD. Further studies using a larger, double-blind, parallel-group design are warranted to confirm these findings.

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Clinical Neuropharmacology

Tập 41 Số 5

151-155

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