Unique ID issued by UMIN | UMIN000014889 |
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Receipt number | R000016228 |
Scientific Title | A randomized, parallel-group, double-blind study of transcranial direct-current stimulation (tDCS) for treatment-refractory auditory hallucinations in patients with schizophrenia |
Date of disclosure of the study information | 2014/08/25 |
Last modified on | 2017/08/31 07:41:25 |
A randomized, parallel-group, double-blind study of transcranial direct-current stimulation (tDCS) for treatment-refractory auditory hallucinations in patients with schizophrenia
A randomized, double-blind study of transcranial direct-current stimulation (tDCS) for auditory hallucinations in schizophrenia
A randomized, parallel-group, double-blind study of transcranial direct-current stimulation (tDCS) for treatment-refractory auditory hallucinations in patients with schizophrenia
A randomized, double-blind study of transcranial direct-current stimulation (tDCS) for auditory hallucinations in schizophrenia
Japan |
Schizophrenia, Schizoaffective disorder
Psychiatry |
Others
NO
To evaluate the efficacy and safety of transcranial direct-current stimulation ( tDCS) for treatment-refractory verbal auditory hallucinations in patients with schizophrenia.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Auditory Hallucination Rating Scale
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
Numbered container method
2
Treatment
Device,equipment |
Five-day (two times per day), 2mA 20 minutes tDCS and 2-month observation period
Five-day (two times per day), 2mA 40 seconds sham stimulation and 2-month observation period
18 | years-old | <= |
59 | years-old | >= |
Male and Female
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
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
20
1st name | |
Middle name | |
Last name | Nobumi Miyake |
St. Marianna University School of Medicine
Department of Neuropsychiatry
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 210-8511
044-977-8111
nobumiyake@marianna-u.ac.jp
1st name | |
Middle name | |
Last name | Nobumi Miyake |
St. Marianna University School of Medicine
Department of Neuropsychiatry
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 210-8511
044-977-8111
nobumiyake@marianna-u.ac.jp
Department of Neuropsychiatry
St. Marianna University School of Medicine
Department of Neuropsychiatry
St. Marianna University School of Medicine
Self funding
Biomedical Engineering and Cognitive Neuroscience for Healthcare, Meiji University
NO
聖マリアンナ医科大学病院(神奈川県)
2014 | Year | 08 | Month | 25 | Day |
Unpublished
Terminated
2014 | Year | 05 | Month | 08 | Day |
2014 | Year | 06 | Month | 01 | Day |
2018 | Year | 02 | Month | 01 | Day |
2018 | Year | 04 | Month | 30 | Day |
2018 | Year | 04 | Month | 30 | Day |
2018 | Year | 04 | Month | 30 | Day |
2014 | Year | 08 | Month | 19 | Day |
2017 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016228
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