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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name