UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006550 |
|---|---|
| Receipt number | R000007648 |
| Scientific Title | Efficacy of Aripiprazole in patients with chronic schizophrenia. |
| Date of disclosure of the study information | 2011/10/16 |
| Last modified on | 2013/10/20 21:22:00 |
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Basic information
Public title
Efficacy of Aripiprazole in patients with chronic schizophrenia.
Acronym
EArS Study
Scientific Title
Efficacy of Aripiprazole in patients with chronic schizophrenia.
Scientific Title:Acronym
EArS Study
Region
| Japan |
Condition
Condition
chronic schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether change from polypharmacy to monotherapy of antipsychotic improves side effects such as EPS, and QOL without worse psychosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Achievement rate of reduction (less or equal two antipsychotics,less or equal 1000mg/day at CP equivalent, and over 20% reduction), Extrapyramidal symptoms (DIEPSS)
Key secondary outcomes
Psychosis (Positive and Negative Syndrome Scale: PANSS), Cognitive function (BACS-J), Preference of medicine (POM)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We will switch from polypharmacy to Aripiprazole, as a main drug, and follow the treatment for 52 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who is diagnosed as schizophrenia usingDSM-IV-TR.
2)Patients who has been forced to receive massive dose of antipsychotics and polypharmacy for a long term and develop extrapyramidal side effects and other side effets.
3)Patients aged 18 and over.
4)Male ans female patients being managed as inpatients and outpatients.
5)Patients who develop negative symptoms predominantly in comparison with positive symptoms.
6)Patients who meet the criteria for medical economy,and are able to give informed concent.
Key exclusion criteria
1)Patient whose a current psychosis is unstable.
2)Patients who are in coma.
3)Patients who are under strong influence of central-nervous depressants,such as barbiturates /anaesthetics.
4)Patients who have received Vegetamin(r).
5)Patients have received epinephrine.
6)Patients who are under influence of neuroactive action by stimulants,alcohol.
7)Patients who have a history of hypersensitivity reaction to aripiprazole.
8)Female patients who are pregnant or may have become pregnant.
9)Patients who are judged inappropriate by investigator.
10)Patients with intellectual disability concomitantly.
11)Patients with dementia
12)patients with personality disorder concomitantly.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Shioiri |
Organization
Gifu University
Division name
Department of Psychiatry, Gifu University Graduate School of Medicine
Zip code
Address
1-1 Yanagido, Gifu, 501-1194, Japan
TEL
058-230-6000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Fukao |
Organization
Gifu University
Division name
Department of Psychiatry, Gifu University Graduate School of Medicine
Zip code
Address
1-1 Yanagido, Gifu, 501-1194, Japan
TEL
058-230-6000
Homepage URL
fukataku@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
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
Kurono Hospital
Younan Hospital
Seinou Hospital
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
岐阜大学医学部附属病院（岐阜県）、黒野病院（岐阜県）、養南病院（岐阜県）、西濃病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 16 | 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
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 16 | Day |
Last modified on
| 2013 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007648
