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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011240
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013171

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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