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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002294
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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