UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012301 |
|---|---|
| Receipt number | R000014385 |
| Scientific 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). |
| Date of disclosure of the study information | 2013/12/08 |
| Last modified on | 2017/11/25 23:45:59 |
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Basic information
Public 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).
Acronym
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).
Scientific 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).
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | ZHAO Yueren |
Organization
Okehazama Hospital Fujita Kokoro Care Center
Division name
Doctors Office
Zip code
Address
Minamiyakata3-879,Sakae-cho,Toyoake-city,Aichi
TEL
(0562)97-1361
zhao@fastmail.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soji Tsuboi |
Organization
Okehazama Hospital Fujita Kokoro Care Center
Division name
Nursing Division
Zip code
Address
Minamiyakata3-879,Sakae-cho,Toyoake-city,Aichi
TEL
(0562)98-1830
Homepage URL
crc-tsuboi.so@seishinkai-kokoro.jp
Sponsor or person
Institute
Okehazama Hospital Fujita Kokoro Care Center
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 05 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014385
