UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized Controlled Trial of Paliperidone and Risperidone for Cognitive and Social Function; Long-Acting Injection in Japanese Schizophrenia Patients (PARASOL-J)
Title of the study (Brief title)	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	Yoshiteru Takekita
Organization	Kansai Medical University
Division name	Department of Neuropsychiatry
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	Yoshiteru Takekita
Organization	Kansai Medical University
Division name	Department of Neuropsychiatry
Address	10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
TEL	06-6992-1001
Homepage URL
Email	takekity@takii.kmu.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, Kansai Medical University
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014342