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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008487
Receipt No. R000009971
Scientific Title Chiba Refractory Schizophrenia Treatment-LAI study
Date of disclosure of the study information 2012/07/20
Last modified on 2012/07/20

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Basic information
Public title Chiba Refractory Schizophrenia Treatment-LAI study
Acronym CREST study
Scientific Title Chiba Refractory Schizophrenia Treatment-LAI study
Scientific Title:Acronym CREST study
Region
Japan

Condition
Condition schizophrenia,schizoaffective disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify effectiveness of risperidone long-acting injection(RLAI) for treatment-resistant schizophrenia(TRS) patients with background of dopamine supersensitivity psychosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Brief Psychiatric Rating Scale
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The diagnosis of schizophrenia or schizoaffective disorder was based on the diagnostic and statistical manual of mental disorders fourth edition text revision.TRS was defined as a failure to respond to at least two antipsychotics belonging to two different chemical classes at dosages equivalent to or greater than 600 mg/day of chlorpromazine for at least 4 weeks and the global assessment of functioning scale 60 or less in the preceding 1 year, or the presence of tardive diskinesia.
Key exclusion criteria Patients who have already received risperidone long- acting injection.
Target sample size 150

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, Chuou-Ku Chiba 260-8670, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhisa Kanahara,Hiroshi Kimura
Organization Graduate School of Medicine, Chiba University
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuou-Ku Chiba 260-8670, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Psychiatry,
Graduate School of Medicine,
Chiba University
Institute
Department

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
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 千葉大学医学部附属病院(千葉県)、千葉大学社会精神保健教育センター(千葉県)、 同和会千葉病院(千葉県)、さつき会袖ヶ浦さつき台病院(千葉県)、学而会木村病院(千葉県)、
同仁会木更津病院(千葉県)、千葉県精神科医療センター(千葉県)、 公徳会佐藤病院(山形県)、銚子こころクリニック(千葉県)、 総合病院 国保旭中央病院(千葉県)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Of the 43 TRS patients at the 6 months observational period following risperidone long-acting injection initiation, 25 (58%) patients were diagnosed as DSP.Following 6 months of RLAI treatment, 17 of these 25 DSP patients (68%) had responded to RLAI.
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 No longer recruiting
Date of protocol fixation
2010 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2012 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To be diagnosed with DSP, patients must have a 3-month history of antipsychotics use and must have at least one of the following criteria
1. Acute relapse or exacerbation of psychosis appears after dose reduction or discontinuation of antipsychotics (during the last 5 years, with 6 weeks for oral medication or 3 months for i.m. depot medication).
2. Tolerance development for antipsychotics (overall increase in dose by 20% or more during the last 5 years ).
3. Extreme tolerance: increased dosages of antipsychotics do not mask the psychotic symptoms any more.
4. Psychotic symptoms upon decrease of medication are new schizophrenia symptoms (not previously seen) or greater severity.
5. Presence or history of TD

Management information
Registered date
2012 Year 07 Month 20 Day
Last modified on
2012 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009971

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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