UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006051 |
|---|---|
| Receipt number | R000007159 |
| Scientific Title | A randomized, parallel-group, double-blind study of high-frequency, repetitive transcranial magnetic stimulation (rTMS) for schizophrenic patients with auditory hallucinations. |
| Date of disclosure of the study information | 2011/07/30 |
| Last modified on | 2017/12/19 20:16:12 |
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Basic information
Public title
A randomized, parallel-group, double-blind study of high-frequency, repetitive transcranial magnetic stimulation (rTMS) for schizophrenic patients with auditory hallucinations.
Acronym
A randomized, parallel-group, double-blind study of repetitive transcranial magnetic stimulation (rTMS) for schizophrenic patients with auditory hallucinations.
Scientific Title
A randomized, parallel-group, double-blind study of high-frequency, repetitive transcranial magnetic stimulation (rTMS) for schizophrenic patients with auditory hallucinations.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masaomi Iyo |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Kanahara |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
kanahara@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 10 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007159
