UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014470
Receipt number R000014342
Scientific Title A Randomized Controlled Trial of Paliperidone and Risperidone for Cognitive and Social Function; Long-Acting Injection in Japanese Schizophrenia Patients (PARASOL-J)
Date of disclosure of the study information 2014/07/10
Last modified on 2018/01/04 09:28:48

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Basic information

Public title

A Randomized Controlled Trial of Paliperidone and Risperidone for Cognitive and Social Function; Long-Acting Injection in Japanese Schizophrenia Patients (PARASOL-J)

Acronym

PARASOL-J study

Scientific Title

A Randomized Controlled Trial of Paliperidone and Risperidone for Cognitive and Social Function; Long-Acting Injection in Japanese Schizophrenia Patients (PARASOL-J)

Scientific Title:Acronym

PARASOL-J study

Region

Japan


Condition

Condition

schizophrenia
schizoaffective disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To examine effectiveness including cognitive function and social function of risperidone long-acting injection and paliperidone palmitate for patients schizophrenia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

PANSS
BACS-J
SFS

Key secondary outcomes

JART-25
GAF
UPSA-B
SWNS-J
SECT
SAS
DIEPSS


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

risperidone long-acting injection

Interventions/Control_2

paliperidone palmitate

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 120 or less
Treatment with RLAI 2 months or more
Being >= 20 years old and competent to contact

Key exclusion criteria

Serious complication
Active suicidal ideations or past suicide attempts
Drug,alcohol abuse
Pregnancy,possibility of pregnancy
Using of oral risperidone or oral paliperidone

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiteru Takekita

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

Email

takekity@takii.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiteru Takekita

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


Email

takekity@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


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

関西医科大学附属滝井病院(大阪府)


Other administrative information

Date of disclosure of the study information

2014 Year 07 Month 10 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

Enrolling by invitation

Date of protocol fixation

2013 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 15 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

2014 Year 07 Month 03 Day

Last modified on

2018 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014342


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name