UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011710 |
|---|---|
| Receipt number | R000013535 |
| Scientific Title | New Chiba Refractory Schizophrenia Treatment (CREST)-LAI study: Effectiveness of Risperidone Long-acting Injectable for Treatment-resistant Schizophrenia |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2015/03/17 07:20:35 |
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Basic information
Public title
New Chiba Refractory Schizophrenia Treatment (CREST)-LAI study: Effectiveness of Risperidone Long-acting Injectable for Treatment-resistant Schizophrenia
Acronym
J-CREST study
Scientific Title
New Chiba Refractory Schizophrenia Treatment (CREST)-LAI study: Effectiveness of Risperidone Long-acting Injectable for Treatment-resistant Schizophrenia
Scientific Title:Acronym
J-CREST study
Region
| Japan |
Condition
Condition
Schizophrenia/Schizoaffective Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness of risperidone long-acting injectable form for patients with treatment-resistant schizophrenia and dopamine supersensitivity psychosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Brief Psychiatric Rating Scale(BPRS: Overall and Gorham, 1962)
Key secondary outcomes
Global Assessment of Functioning (GAF)
Clinical Global Impression Scale-Severity/-Change
Extrapyramidal Symptom Rating Scale (ESRS: Chouinard and Margolese, 2005)
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Risperidone long-acting injectable (RLAI) group:
The patient is injected every two weeks for 6 months, adjunctively with any other antipsychotic(s) except clozapine and ECT.
The dose is 25mg, 37.5mg or 50mg, which can be clinically adjusted.
This treatment phase is followed by further 18 months observational phase.
Interventions/Control_2
Treatment As Usual group:
The patient is treated with any antipsychotic(s) except RALI, clozapine and ECT.
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
1)Schizophrenia or schizoaffective disorder (DSM-4-TR)
2)Criteria of treatment-resistant schizophrenia
A)Failure to respond to at least two antipsychotics belonging to two different chemical classes, at dosages equivalent to, or greater than a 600mg/day chlorpromazine equivalent (CPZE)-dose for at least 4 weeks
B)Documented diagnosis of tardive dyskinesia (TD), as well as an average yearly Global Assessment of Functioning (GAF) score of less than 61
3)Critera of dopamine supersensitivity psychosis (slightly modified from the Chouinard Research Diagnosis Criteria for Supersensitivity Psychosis: Chouinard, 1990):
A)With a treatment history by antipsychotic(s) for over 3 months
B)Meeting at least one item from the following dopamine supersensitivity episodes, within one year prior to the study enrollment:
(1)Acute relapse or exacerbation of psychosis appearing after a dose reduction or discontinuation of antipsychotics, within 6 weeks for oral medication or 3 months for intramuscular medication
(2) Tolerance to antipsychotic effects has developed. This is defined as when an acute relapse or exacerbation of psychosis occurs, independent of a dose reduction or discontinuation of antipsychotic therapy and stable psychotic state.
(3)Relapse episodes cannot be successfully controlled by a 20% increased titration of drug.
(4)Psychotic symptoms which are new to the patient, or of greater severity, occurring immediately after a decrease in drug dosage
Key exclusion criteria
A)with a treatment history of RLAI injection
B)under treatment with clozapine
C)under ECT treatment
D)with any other Axis 1 or 2 psychiatric disorder
E)with clinically severe physical disease
F)with pregnancy or suspected pregnancy
G)a physician assessed the patient as unsuitable for participation in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Iyo |
Organization
Chiba University, Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
Iyom@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Kanahara |
Organization
Chiba University, Center for forensic Mental Health
Division name
Division of Clinical Treatment and Rehabilitation
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
Homepage URL
kanahara@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Sciences Research Grant from Japanese ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Tokyo Metropolitan Matsuzawa Hospital, Shiga Psychiatric Mental Center, National Hospital Organization Yamato Mental Medical Center, National Hospital Organization Ryukyu Hospital, National Center of Neurology and Psychiatry, National Hospital Organization Kurihama Medical and Addiction Center, Osaka Psychiatric Medical Center
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 20 | 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 | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | 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
| 2013 | Year | 09 | Month | 11 | Day |
Last modified on
| 2015 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013535
