UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008487 |
|---|---|
| Receipt number | 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 20:00:31 |
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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
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
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（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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009971
