UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011240 |
|---|---|
| Receipt number | R000013171 |
| Scientific Title | Feasibility and efficacy study of Social cognition and Interaction Training(SCIT) |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2014/05/28 09:42:38 |
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Basic information
Public title
Feasibility and efficacy study of Social cognition and Interaction Training(SCIT)
Acronym
Feasibility and efficacy study of Social cognition and Interaction Training(SCIT)
multicenter randomized clinical trial
Scientific Title
Feasibility and efficacy study of Social cognition and Interaction Training(SCIT)
Scientific Title:Acronym
Feasibility and efficacy study of Social cognition and Interaction Training(SCIT)
multicenter randomized clinical trial
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility (treatment adherence rate) and efficacy (Intrinsic Motivation Inventory:IMI) of Social cognition and Interaction Training (SCIT), which is a program of social cognitive rehabilitation for schizophrenia in Japanese setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
a) treatment adherence rate
b) intrinsic motivation for SCIT assessed by IMI(intrinsic motivation inventory)
Key secondary outcomes
a) change of psychiatric symptom severity assessed by PANSS
b) change of neurocognitive function assessed by BACS
c) change of social cognition assessed by FEIT, Hinting task, SCSQ
d) change of metacognition assessed by MCQ
e) change of social functioning assessed by SFS and GAF
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
60 min session per week/SCIT
Interventions/Control_2
Treatment as usual without cognitive rehabilitation but attending to other psychosocial treatment programs at least once a week
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
60 patients with schizophrenia or schizoaffective disorder according to DSM-IV-TRcriteria recruited from outpatients of National Center of Neurology and Psychiatry(NCNP).All patients are 20-65 years-old, who are attending to a psychosocial treatment program at least once a week, and have the capacity to give written informed consent
Key exclusion criteria
Serious suicidal ideation present at screening,
History of substance/alcohol use disorder within 3 months prior to the screening,
Estimated IQ lower than 70 assessed by Japanese Adult Reading Test (JART),
Life-threatening, severe or unstable physical disorders at screening,
Patients that were decided to be inapprop
riate to participate in the study by the doctor in charge and/or the investigator for any other reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Nakagome |
Organization
Translational Medical Center, National Center of Neurology and Psychiatry
Division name
Clinical Research Support Office
Zip code
Address
4-1-1,Ogawa-Higashi,Kodaira,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Kanie |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Psychiatry
Zip code
Address
4-1-1,Ogawa-Higashi,Kodaira,Tokyo
TEL
Homepage URL
Sponsor or person
Institute
National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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病院(東京都),帝京大学医学部附属病院（東京都）,鳥取大学医学部附属病院（鳥取県）,東邦大学医学部附属病院（東京都）,大阪府立精神医療センター病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 21 | Day |
Last modified on
| 2014 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013171
