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Recruitment status Terminated
Unique ID issued by UMIN UMIN000011710
Receipt No. 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

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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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email kanahara@faculty.chiba-u.jp

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013535


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