UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized, parallel-group, double-blind study of transcranial direct-current stimulation (tDCS) for treatment-refractory auditory hallucinations in patients with schizophrenia
Title of the study (Brief title)	A randomized, double-blind study of transcranial direct-current stimulation (tDCS) for auditory hallucinations in schizophrenia
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of transcranial direct-current stimulation ( tDCS) for treatment-refractory verbal auditory hallucinations in patients with schizophrenia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Auditory Hallucination Rating Scale
Key secondary outcomes	Positive and Negative Syndrome Scale, Brief Assessment of Cognition in Schizophrenia, Schizophrenia Cognition Rating Scale, University of California, San Diego, Performance-Based Skills Assessment, Clinical Global Impression-severity, Schizophrenia Quality of Life Scale, Drug-Induced Extrapyramidal Symptoms Scale, Brain metabolism, Laboratory tests

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	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Five-day (two times per day), 2mA 20 minutes tDCS and 2-month observation period
Interventions/Control_2	Five-day (two times per day), 2mA 40 seconds sham stimulation and 2-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	18 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Meeting DSM-IV-TR criteria for schizophrenia or schizoaffective disorder. 2)Don't reach score 0 of auditory hallucination in AHRS, regardless of pharmacotherapy of antipsychotic drugs with sufficient dosage and duration. 3)"Suffient dose" refers to more than 600mg/day chlorpromazine-equivalent dose and "sufficient duration" refers to more than 4 weeks. 4)Right-handed
Key exclusion criteria	1)Past history of traumatic brain injury with loss of conciousness 2)With cripping device or electrode of deep brain stimulation 3)With embedding cochlea stimulating device 4)With cardiac pacing device 5)Epilepsy and past history of epilepsy 6)Meeting DSM-IV-TR criteria for alcohol or other substance abuse or dpendence 7)Meeting DSM-IV-TR criteria for mental retardation or personality disorder 8)Past history of cerebrovascular disease 9)Severe neurological disease 10)Under treatment of severe infection disease or malignancy 11)Pregnant woman and under breast feeding 12)Active expression of suicidal ideation 13)Left-handed 14)Judged inappropriate to participate into the study by medical doctor
Target sample size	20

Research contact person
Name of lead principal investigator	Nobumi Miyake
Organization	St. Marianna University School of Medicine
Division name	Department of Neuropsychiatry
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 210-8511
TEL	044-977-8111
Email	nobumiyake@marianna-u.ac.jp

Public contact
Name of contact person	Nobumi Miyake
Organization	St. Marianna University School of Medicine
Division name	Department of Neuropsychiatry
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 210-8511
TEL	044-977-8111
Homepage URL
Email	nobumiyake@marianna-u.ac.jp

Sponsor
Institute	Department of Neuropsychiatry St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Department of Neuropsychiatry St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Biomedical Engineering and Cognitive Neuroscience for Healthcare, Meiji University
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	聖マリアンナ医科大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 25 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 08 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2018 Year 02 Month 01 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 04 Month 30 Day

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

Management information
Registered date	2014 Year 08 Month 19 Day
Last modified on	2017 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016228