UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023445 |
|---|---|
| Receipt number | R000026595 |
| Scientific Title | Qualitative assessment and evaluation for change of patient oriented QOL regarding long-acting injectable antipsychotics for schizophrenia |
| Date of disclosure of the study information | 2016/08/08 |
| Last modified on | 2017/09/12 12:31:51 |
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Basic information
Public title
Qualitative assessment and evaluation for change of patient oriented QOL regarding long-acting injectable antipsychotics for schizophrenia
Acronym
QUAIL-Study
Scientific Title
Qualitative assessment and evaluation for change of patient oriented QOL regarding long-acting injectable antipsychotics for schizophrenia
Scientific Title:Acronym
QUAIL-Study
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
qualitative and quantitative evaluation for change of patient oriented QOL regarding switching from oral antipsychotics to long-acting injection for schizophrenia patient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The schedule for the evaluation of individual quality of life-direct weighting (SEIQoL-DW)
Interview to patients for using Grounded Theory Approach
Key secondary outcomes
Specific level of functioning scale (SLOF)
Positive and negative syndrome (PANSS)
Drug-Induced extrapyramidal symptoms scale (DIEPSS)
Japanese adult reading test (JART)
Beck Cognitive Insight Scale(BCIS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
aripiprazole once monthly, paliperidone palmitate or risperidone long-acting injection
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosis of schizophrenia and schizoaffective disorder according to DSM-IV criteria
PANSS score 100 or less and the item of delusions and hallucinations in positive symptom 4 or less
Treatment with oral aripiprazole, risperidone, paliperidone 2 months or more, or patient who could be confirmed efficacy and tolerability of these antipsychotics now or past.
switching from oral antipsychotic to long-acting injection
JART score 70 or more
Being >= 20 years old and competent to contact
Key exclusion criteria
Subjects are difficulty in accomplishment of the interview
Subjects using antipsychotics 3 or more
Subjects who principal investigator decide unsuitable for this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichiro Nishida |
Organization
Kansai Medical University
Division name
Department of Neurospychiatry
Zip code
Address
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
TEL
06-6992-1001
koshikay@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Koshikawa |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
Address
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
TEL
06-6992-1001
Homepage URL
koshikay@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
No
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
関西医科大学 総合医療センター (大阪府)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | 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
| 2016 | Year | 08 | Month | 02 | Day |
Last modified on
| 2017 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026595
