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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001834
Receipt No. 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

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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
Email

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
Email hirotak@dk9.so-net.ne.jp

Sponsor
Institute Keio University, School of Medicine
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002200

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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