UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetics differences in risperidone and 9-OH risperidone: relation to inserted depth of injection needle in the people with schizophrenia who treated with regularly risperidone long acting injection (RLAI).
Title of the study (Brief title)	Pharmacokinetics differences in risperidone and 9-OH risperidone: relation to inserted depth of injection needle in the people with schizophrenia who treated with regularly risperidone long acting injection (RLAI).
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To Evaluate effect for blood level of risperidone and 9-OH risperidone concentration with the difference insertion depths of the gluteal muscles intramuscular injection needle.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum concentration of risperidone and 9-OH risperidone
Key secondary outcomes	1) Positive and Negative Syndrome Scale; PANSS 2) Clinical Global Impression; CGI 3) Drug-induced Extrapyramidal Symptoms Scale; DIEPSS 4) Visual Analogue Scale; VAS 5) Injection Site Reactions 6) Demography 7) Concomitant Medications 8) Cost(i.e. medical remuneration points ) 9) CYP2D6 gene polymorphism 10) Brain-derived neurotorophic factor; BDNF

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Group to deeply (50mm from the surface of patient's skin) penetrate the RLAI needle
Interventions/Control_2	Group to shallowly (20mm from the surface of patient's skin) penetrate the RLAI needle
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	The subjects will be patients meeting all of the following criteria. 1) Patients with F2 criteria meeting the ICD-10 diagnosis 2) Patients who had previously enrolled to the Research on nursing technique in intramuscular injection. 3) Patients who personally give written informed consent to participate in the study. 4) Patients who require treatment with risperidone long acting injection (RLAI), and all of whom being administered RLAI regularly for more than 6 weeks to the the base lined date of the study 5) Inpatients or outpatients 6) Patients who personally give written informed consent to obtain information about CYP2D6 gene polymorphism.
Key exclusion criteria	Patients meeting any of the following criteria will be excluded from the study. 1) PANSS total score over 130 points. 2) Patients who need to be treated with risperidone or paliperidone during this research.
Target sample size	30

Research contact person
Name of lead principal investigator	ZHAO Yueren
Organization	Okehazama Hospital Fujita Kokoro Care Center
Division name	Doctors Office
Address	Minamiyakata3-879,Sakae-cho,Toyoake-city,Aichi
TEL	(0562)97-1361
Email	zhao@fastmail.jp

Public contact
Name of contact person	Soji Tsuboi
Organization	Okehazama Hospital Fujita Kokoro Care Center
Division name	Nursing Division
Address	Minamiyakata3-879,Sakae-cho,Toyoake-city,Aichi
TEL	(0562)98-1830
Homepage URL
Email	crc-tsuboi.so@seishinkai-kokoro.jp

Sponsor
Institute	Okehazama Hospital Fujita Kokoro Care Center
Institute
Department

Funding Source
Organization	Department of Psychiatry, Fujita Health University, School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	医療法人静心会桶狭間病院 藤田こころケアセンター

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 05 Day
Anticipated trial start date	2013 Year 12 Month 09 Day
Last follow-up date	2014 Year 04 Month 18 Day
Date of closure to data entry	2014 Year 06 Month 30 Day
Date trial data considered complete	2015 Year 11 Month 24 Day
Date analysis concluded	2015 Year 12 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 14 Day
Last modified on	2017 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014385