UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized, parallel-group, double-blind study of high-frequency, repetitive transcranial magnetic stimulation (rTMS) for schizophrenic patients with auditory hallucinations.
Title of the study (Brief title)	A randomized, parallel-group, double-blind study of repetitive transcranial magnetic stimulation (rTMS) for schizophrenic patients with auditory hallucinations.
Region	Japan

Condition
Condition	Schizophrenia, Schizoaffective disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of effectiveness of high-frequency rTMS for auditory hallucinations.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Auditory Hallucination Rating Scale
Key secondary outcomes	Positive and Negative Syndrome Scale, Brief Psychiatric Rating Scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Two-day (two times in the morning and in the evening per day), 20Hz active rTMS procedure and one-month observation period
Interventions/Control_2	Two-day (two times in the morning and in the evening per day), sham procedure and one-month observation period
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	A) Don't reach score 0 of auditory hallucination in AHRS, regardless of pharmacotherapy of antipsychotics with sufficient dose and duration. B)"Sufficient dose" refers to more than 600mg/day chlorpromazine-equivalent dose and "sufficient duration" refers to more than 4 weeks.
Key exclusion criteria	1) Traumatic brain injury with loss of consciousness 2) With cripping device or electrode of deep brain stimulation 3) With embedding cochlea stimulating device 4) With cardiac pacing device 5) Epilepsy 6) Abuse or dependence of alcohol or any illegal drugs 7) Mental retardation or personality disorder 8) Cerebrovascular disease 9) Severe neurological disease 10) Under treatment of severe infection disease or malignancy 11) Pregnant woman 12) Left-handed 13) judged inappropriate to participate into the study by medical doctor
Target sample size	40

Research contact person
Name of lead principal investigator	Masaomi Iyo
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Psychiatry
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Email

Public contact
Name of contact person	Nobuhisa Kanahara
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Psychiatry
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Homepage URL
Email	kanahara@faculty.chiba-u.jp

Sponsor
Institute	Department of Psychiatry, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	None
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	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 10 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2015 Year 09 Month 13 Day
Date of closure to data entry	2015 Year 09 Month 13 Day
Date trial data considered complete	2015 Year 09 Month 13 Day
Date analysis concluded	2015 Year 09 Month 13 Day

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

Management information
Registered date	2011 Year 07 Month 27 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007159