UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012949 |
|---|---|
| Receipt number | R000015144 |
| Scientific Title | Efficacy of intervention by Sensory Modulation Room in agitated patients with schizophrenia;An exploratory randomized controlled trial, a series of N-of-1 studies |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2015/03/19 19:46:10 |
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Basic information
Public title
Efficacy of intervention by Sensory Modulation Room in agitated patients with schizophrenia;An exploratory randomized controlled trial, a series of N-of-1 studies
Acronym
Efficacy of intervention by Sensory Modulation Room in agitated patients with schizophrenia;An exploratory study
Scientific Title
Efficacy of intervention by Sensory Modulation Room in agitated patients with schizophrenia;An exploratory randomized controlled trial, a series of N-of-1 studies
Scientific Title:Acronym
Efficacy of intervention by Sensory Modulation Room in agitated patients with schizophrenia;An exploratory study
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy of the sensory modulation room intervention for agitation in patients with schizophrenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale(6 items)
Clinical Global Impression(CGI)
Positive and Negative Syndrome Scale-Excited Component(PANSS-EC)
Key secondary outcomes
Pressure
Pulse
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
| Behavior,custom |
Interventions/Control_1
40min program in sensory modulation room
Interventions/Control_2
Treatment as usual without use of sensory modulation room
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Being judged to be able to express free will by multi-disciplinary team in charge
2) Meeting DSM-IV-TR criteria for schizophrenia
3) 20 years or older.Less than 60 years old
4) Finishing the assessment of sensory modulation and having used the sensory modulation room more than once
5) Patients for whom changes in main medication were presumed to be not necessary during the study
6) After explain the aims and nature of the study,capable of giving informed consent to participate in it
Key exclusion criteria
1)History of epilepsy (Possibility of using light stimulations)
2)Serious suicidal ideation or possibility of harming themselves and others present at screening
3)Possible physical violence to intervening person at study
4)Unstable physical disorders(Performance Status 3 or 4)
5)No possibility of finishing intervention within the time limit because of discharge or hospital transfer
6)Other conditions deemed to affect the study eligibility
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mayumi Yamano |
Organization
National Center of Neurology and Psychiatry
Division name
Rehabilitation office
Zip code
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL
042-341-2711
myamano@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Yamano |
Organization
National Center of Neurology and Psychiatry
Division name
Rehabilitation office
Zip code
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
myamano@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Grant for Young Researchers of NCNP
Organization
Division
Category of Funding Organization
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
国立精神・神経医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 24 | Day |
Last modified on
| 2015 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015144
