UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Repetitive transcranial magnetic stimulation (rTMS) in treatment resistant eating disorders: a randomised, sham-controlled trial
Title of the study (Brief title)	EDTMS-Chiba
Region	Japan

Condition
Condition	patients with a Diagnostic and Statistical Manual for Mental Disorders (DSM-5)diagnosis of Bulimia Nervosa (BN), or Anorexia Nervosa binge-purging type(ANBP), or Binge Eating Disorder (BED)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this randomised sham-controlled study is to investigate the therapeutic efficacy of the left dorsolateral prefrontal cortex (DLPFC)in people with treatment resistant eating disorders.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	The primary outcome measure, administered before and after the rTMS sessions, is the change in a 10-cm visual analogue scale (VAS) of "urge to eat".
Key secondary outcomes	1. the change in a VAS of urge to binge-eat 2. the change in a VAS of level of hunger 3. the change in a VAS of level of anxiety 4. the change in a VAS of level of tension 5. the change in a VAS of current mood 6. the Food Craving Questionnaire-State (FCQ-S) scores 7. the Bulimic Investigatory Test, Edinburgh (BITE) 8. the Hamilton Depression Rating Scale 9. the Hamilton Anxiety Rating Scale 10. the Clinical Global Impression Scale Severity/Change(CGIS/CGIC) 11. the Global Assessment of Functioning(GAF) 12. the Eating Disorder Examination Questionnaire(EDEQ) 13. the Eating Disorder Inventory2(EDI2) 14. the Hospital Anxiety and Depression Scale(HADS) 15. the Cognitive Flexibility Scale(CSF) 16. neurocognitive tasks(the stroop test, Brixton test,Trail-making test) 17. Serum levels of BDNF, proBDNF 18. Event-related potential(ERP) 19. Skin conductance response(SCR) 20. the State-Trait Anger eXpression Inventory (STAXI)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	We provide real high-frequency rTMS to the left DLPFC with a Magstim Rapid System(MRS)1000(Magstim Company Ltd,Wales,UK)
Interventions/Control_2	We provide sham coil to the left DLPFC.
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	49 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Participants are recruited from the Department of Psychiatry, inpatient unit or outpatient uni,t Chiba University Hospital. Diagnosis is established with the eating disorders, BN, AN or BED, based on DSM-5 criteria. 2. Participants are enrolled if they had at least six binges over the previous 28 days as assessed with the Eating Disorder Examination-Questionnaire (EDE-Q). CGI>=4. 3. Written informed consent is obtained from all the participants. 4. Participants are age between 20 and 48. 5. The criteria for treament-resistance is as follows; 1) BITE severity scores over 5, BITE symptom scores over 15, CGI-C>3, after 12 weeks intervention with sufficient dose of SSRI. 2) BITE severity scores over 5, BITE symptom scores over 15, CGI-C>3, with discontinuance of SSRI because of tolerability. 3)BITE severity scores over 5, BITE symptom scores over 15, CGI-C>3, after 12 weeks with CBT.
Key exclusion criteria	Past history of brain injury with disturbance of consciousness, with heart pace-maker, pregnancy, nicotine use exceeding the equivalent of >10 cigarettes/ day, substance dependence, mental retardation, personality disorders, severe infection, cancer, physical illness.
Target sample size	48

Research contact person
Name of lead principal investigator	Michiko Nakazato
Organization	Chiba University Graduate School of Medicine
Division name	Research Center for Child Mental Development
Address	1-8-1 Inohana, Chuo-ku, Chiba city, Chiba
TEL	043-226-2975
Email	nakazato@faculty.chiba-u.jp

Public contact
Name of contact person	Michiko Nakazato
Organization	Chiba University
Division name	Research Center for Child Mental Development
Address	1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL	043-226-2975
Homepage URL
Email	nakazato@faculty.chiba-u.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	Grants-in-Aid-for Scientific Research
Organization
Division
Category of Funding Organization
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	千葉大学医学部付属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 17 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 09 Month 16 Day
Anticipated trial start date	2014 Year 12 Month 15 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 07 Month 31 Day
Date analysis concluded	2017 Year 08 Month 31 Day

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

Management information
Registered date	2014 Year 12 Month 17 Day
Last modified on	2019 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018327