UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001834 |
|---|---|
| Receipt number | R000002200 |
| Scientific Title | Effects of Antipsychotic Reduction on Negative Subjective Experience and Cognitive Function |
| Date of disclosure of the study information | 2009/03/31 |
| Last modified on | 2011/10/31 09:34:38 |
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Basic information
Public title
Effects of Antipsychotic Reduction on Negative Subjective Experience and Cognitive Function
Acronym
Antipsychotic Reduction Study
Scientific Title
Effects of Antipsychotic Reduction on Negative Subjective Experience and Cognitive Function
Scientific Title:Acronym
Antipsychotic Reduction Study
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes of subjective experience and cognitive function following dose reduction of risperidone or olanzapine in patients with schizophrenia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Profile of Mood States (POMS) -Brief Form Japanese Version
2) Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Key secondary outcomes
1) Subjective Well-being under Neuroleptic drug treatment Short form, Japanese version (SWNS-J)
2) Drug Attitude Inventory (DAI) -10
3) Clinical Global Impression–Schizophrenia (CGI-SCH)
4) Positive and Negative Syndrome Scale (PANSS)
5) Japanese version of the Calgary Depression Scale for Schizophrenics (JCDSS)
6) Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS)
7) EuroQoL
8) Japanese version of the Schedule for Assessment of Insight (SAI-J)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Risperidone or olanzapine will be reduced by 12.5% per 2 weeks or 25% per 4 weeks until a total reduction rate reaches 50%. In case a dose reaches 2mg/day (risperidone) or 5mg/day (olanzapine), the reduction will be terminated.
Interventions/Control_2
The dose of risperidone or olanzapine will be maintained.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) schizophrenia or schizoaffective disorder (DSM-IV)
2) being treated with a fixed dose of risperidone or olanzapine for at least three months
3) less than moderate (a score <4) on the following PANSS positive subscale items: delusion, hallucinatory behavior, conceptual disorganization, and suspiciousness
Key exclusion criteria
the presence of any significant medical neurological illness
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Uchida |
Organization
Keio University, School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyoshi Takeuchi |
Organization
Keio University, School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
TEL
Homepage URL
hirotak@dk9.so-net.ne.jp
Sponsor or person
Institute
Keio University, School of Medicine
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
慶應義塾大学病院（東京都）、大泉病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 31 | Day |
Last modified on
| 2011 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002200
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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