Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395499
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2006-11-02
Brief Title:
Measurement of Risperidone and 9-Hydroxyrisperidone in Plasma and Saliva
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Measurement of Risperidone and 9-Hydroxyrisperidone in Plasma and Saliva
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to 1 examine the secrection of risperidone RIS Risperdal and its metabolite 9-OH-RIS in saliva 2 determine the concentration ratio of RIS and 9-OH-RIS between plasma and saliva and 3 compare the rate of decline in concentration of RIS and 9-OH-RIS in saliva and plasma by measurements at timed intervals during a single dosing interval
Detailed Description:
The purpose of this research is to 1 examine the secrection of risperidone RIS Risperdal and its metabolite 9-OH-RIS in saliva 2 determine the concentration ratio of RIS and 9-OH-RIS between plasma and saliva and 3 compare the rate of decline in concentration of RIS and 9-OH-RIS in saliva and plasma by measurements at timed intervals during a single dosing interval
RIS is a new atypical neuroleptic agent widely used in treatment of schizophrenia and related disorders It is sometimes used in serious childhood disorders as well such as autistic disorder It has a beneficial effect on both positive and negative symptoms of schizophrenia accompanied by a much lower incidence of adverse effects eg parkinsonism tardive dyskinesia dystonias neuroleptic malignant syndrome RIS is also used as a treatment of children with pervasive developmental disorders PDD RIS is metabolized to 9-OH-RIS by hepatic CYP2D6 which exhibits genetic polymorphism Since RIS and 9-OH-RIS are equally potent the clinical significance of CYP 2D6 status is negligible However in extensive metabolizers EM the T12 or RIS is about 3 hrs and taht of 9-OH-RIS is approximately 20 hrs In poor metabolizers PM the half life of RIS is about 17 hrs and that of 9-OH-RIS 23 hrs
Since compliance is a major problem in the management of schizophrenia we are developing a rapid simplified test to measure RIS and 9-OH-RIS in salive and compare the concentration in samples of plasma collected concurrently In this study 12 adult patients 18 years and above or minors aged 5 to 17 years already taking risperidone for clinical reasons will take their usual morning dose Risperidone is usually administered once or twice a day
At various intervals thereafter a 1 to 2-milliliter specimen of saliva will be removed from the oral cavity by means of a syringe in some cases it is more convenient to ask volunteers to expel saliva into a plastic cup We will try to cover an 18-hour interval following dosing for the entire group samples will be collected at 14 12 1 2 4 8 12 and 18 hours after taking the medicine However only some of the samples 2 or maximum of 3 will be gathered from any single patient Following collection of saliva a sample of 2 to 4 ml of blood will be withdrawn and plasma will be separated and frozen Saliva and plasma samples will gathered where the patients drug concentrations would ordinarily be collected eg Inpatient or Outpatient clinics or phlebotomy laboratory RIS concentrations will be measured by high pressure liquid chromatography HPLC
RIS is a new atypical neuroleptic agent widely used in treatment of schizophrenia and related disorders It is sometimes used in serious childhood disorders as well such as autistic disorder It has a beneficial effect on both positive and negative symptoms of schizophrenia accompanied by a much lower incidence of adverse effects eg parkinsonism tardive dyskinesia dystonias neuroleptic malignant syndrome RIS is also used as a treatment of children with pervasive developmental disorders PDD RIS is metabolized to 9-OH-RIS by hepatic CYP2D6 which exhibits genetic polymorphism Since RIS and 9-OH-RIS are equally potent the clinical significance of CYP 2D6 status is negligible However in extensive metabolizers EM the T12 or RIS is about 3 hrs and taht of 9-OH-RIS is approximately 20 hrs In poor metabolizers PM the half life of RIS is about 17 hrs and that of 9-OH-RIS 23 hrs
Since compliance is a major problem in the management of schizophrenia we are developing a rapid simplified test to measure RIS and 9-OH-RIS in salive and compare the concentration in samples of plasma collected concurrently In this study 12 adult patients 18 years and above or minors aged 5 to 17 years already taking risperidone for clinical reasons will take their usual morning dose Risperidone is usually administered once or twice a day
At various intervals thereafter a 1 to 2-milliliter specimen of saliva will be removed from the oral cavity by means of a syringe in some cases it is more convenient to ask volunteers to expel saliva into a plastic cup We will try to cover an 18-hour interval following dosing for the entire group samples will be collected at 14 12 1 2 4 8 12 and 18 hours after taking the medicine However only some of the samples 2 or maximum of 3 will be gathered from any single patient Following collection of saliva a sample of 2 to 4 ml of blood will be withdrawn and plasma will be separated and frozen Saliva and plasma samples will gathered where the patients drug concentrations would ordinarily be collected eg Inpatient or Outpatient clinics or phlebotomy laboratory RIS concentrations will be measured by high pressure liquid chromatography HPLC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None