UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002294 |
|---|---|
| Receipt number | R000002804 |
| Scientific Title | Predicting Antipsychotic Plasma Level Before Dosage Change: Population Pharmacokinetic Analysis |
| Date of disclosure of the study information | 2009/08/20 |
| Last modified on | 2012/02/06 08:14:04 |
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Basic information
Public title
Predicting Antipsychotic Plasma Level Before Dosage Change: Population Pharmacokinetic Analysis
Acronym
Predicting Antipsychotic Plasma Level
Scientific Title
Predicting Antipsychotic Plasma Level Before Dosage Change: Population Pharmacokinetic Analysis
Scientific Title:Acronym
Predicting Antipsychotic Plasma Level
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A close association between plasma antipsychotic level and dopamine D2 receptor occupancy suggests that the plasma antipsychotic level can be used to predict D2 receptor occupancy. Individualized dosing with the measurement of antipsychotic plasma levels, therefore, becomes a real potential clinical application. Given a high interindividual variability in peripheral pharmacokinetic parameters, the next hurdle is in robustly predicting antipsychotic plasma levels before changing a dose for each individual. In this study, we will attempt to test the validity and reliability of predicting plasma levels of risperidone and 9-hydroxyrisperidone before performing a dosage change, using population pharmacokinetic modeling.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An interclass correlation coefficient between predicted and observed plasma antipsychotic levels will be calculated.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) DSM-IV/SCID diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychotic disorder NOS
(2) Having been treated with oral risperidone or olanzapine at a steady dose for at least 7 days
(3) Antipsychotic dosage change is clinically indicated
(4) Capable to provide informed consent
Key exclusion criteria
(1) Past history of vasovagal reflection associated with injection
(2) History of treatment with long-acting risperidone within 3 months
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Uchida |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
160-8582 35 Schinanomachi, Shinjuku-ku
TEL
+81.3.5363.3829
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
TEL
81.3.5363.3829
Homepage URL
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 20 | 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
50 subjects participated in this study. The mean (95% CI) prediction errors (ng/mL) were as low as 0.0 (-1.3-1.4) for RIS and 1.0 (-1.1-3.0) for 9-OH-RIS. The observed and predicted concentrations of RIS and 9-OH-RIS were highly correlated, respectively (r=0.96, p<0.0001 and r=0.92, p<0.0001, respectively).
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
| 2009 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, people who will need a dosage change of risperidone or olanzapine for clinical reasons(s) will be included. No dosage change will be performed only for the purpose of participating in this study.
Management information
Registered date
| 2009 | Year | 08 | Month | 05 | Day |
Last modified on
| 2012 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002804
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
