Child Development Disorders, PervasivePhase 1NCT00147394
Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)
A Phase 1 study testing Risperidone in people with Child Development Disorders, Pervasive, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
Trial summary
The purpose of this research is to study the pharmacokinetics of risperidone in a group of pediatric patients with Pervasive Developmental Disorder (PDD). The study will determine how much risperidone and its breakdown product, 9-hydroxy-risperidone, is in the blood following the patient's usual daily dose. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Child Development Disorders, Pervasive
- What is being tested?
- Risperidone
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2001to Jun 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female patients between ages of 5 and less than 17 years.
- Patients meeting DSM-IV criteria for PDD-NOS about to initiate clinical treatment or currently clinically treated with risperidone.
- Patients with autistic disorder or PDD-NOS currently on risperidone as a participant in one of the multi-site RUPP protocols.
Who cannot join
- Children taking psychotropic or other medication that will interact with target CYP 450 isoenzyme activity will not be eligible for the pharmacokinetic study (i.e. CYP2D6 or CYP3A4; to be decided by the PI)
- Patients with known renal or hepatic dysfunction (e.g. serum creatinine > 1.5 normal upper limit, transaminases or bilirubin > 2 times normal upper limit)
- Failure of the parent/legal guardian to give informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106-6010
The Ohio State University Medical Center
Columbus, Ohio, 43210-1296
Children's Hospital of Michigan/Wayne State University
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder
The purpose of this research is to study the pharmacokinetics of risperidone in a group of pediatric patients with Pervasive Developmental Disorder (PDD). The study will determine how much risperidone and its breakdown product, 9-hydroxy-risperidone, is in the blood following the patient's usual daily dose. The study is designed to look at how fast children absorb, breakdown, and eliminate risperidone.
Read the detailed description
Pervasive Developmental Disorders is a category of disorders that includes autism and related conditions. While these disorders are rare, they represent a significant public health problem because they are extremely debilitating and lack efficacious therapies. Neuroleptic use in PDD is high and the population appears to be at increased risk of serious sequelae including tardive dyskinesia. Newer atypical neuroleptics including risperidone are now used in 87% of cases but dosing, safety and efficacy is undetermined in the vulnerable population.
This study consists of a total of 3 visits, the initial screening visit where consent, medical history, demographics and vitals will be recorded. Two additional visits with blood sampling will occur. The second visit will be no greater than 30 days from the screening visit and the 3rd visit will be one month from Visit 2.
- Conditions
- Child Development Disorders, Pervasive
- Being tested
- Risperidone
- Keywords
- Risperidone, Autism, PDD, Pervasive Developmental Disorder
- Medical subject headings
- Child Development Disorders, Pervasive, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the variability of clearance and volume of distribution among AE rating, weight gain and ABC responder status.
Secondary outcomes (1)
Exploratory analysis will be performed to examine the relationship of other factors to risperidone and metabolite concentrations for PK/PD assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startDec 2001
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Development Disorders, PervasiveStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Vinks, Pharm.D., Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147394
- Sponsor's protocol ID
- PPRU 10544
- Status last verified
- Oct 2012
- First submitted
- 2 Sep 2005
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder
- ClinicalTrials.gov ID
- NCT00147394
- Acronym / sponsor ID
- PPRU 10544
- Conditions
- Child Development Disorders, Pervasive
- Keywords
- Risperidone, Autism, PDD, Pervasive Developmental Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Dec 2001
- Study completion
- Jun 2004 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to study the pharmacokinetics of risperidone in a group of pediatric patients with Pervasive Developmental Disorder (PDD). The study will determine how much risperidone and its breakdown product, 9-hydroxy-risperidone, is in the blood following the patient's usual daily dose. The study is designed to look at how fast children absorb, breakdown, and eliminate risperidone.
Detailed description
Pervasive Developmental Disorders is a category of disorders that includes autism and related conditions. While these disorders are rare, they represent a significant public health problem because they are extremely debilitating and lack efficacious therapies. Neuroleptic use in PDD is high and the population appears to be at increased risk of serious sequelae including tardive dyskinesia. Newer atypical neuroleptics including risperidone are now used in 87% of cases but dosing, safety and efficacy is undetermined in the vulnerable population.
This study consists of a total of 3 visits, the initial screening visit where consent, medical history, demographics and vitals will be recorded. Two additional visits with blood sampling will occur. The second visit will be no greater than 30 days from the screening visit and the 3rd visit will be one month from Visit 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male and female patients between ages of 5 and less than 17 years.
- Patients meeting DSM-IV criteria for PDD-NOS about to initiate clinical treatment or currently clinically treated with risperidone.
- Patients with autistic disorder or PDD-NOS currently on risperidone as a participant in one of the multi-site RUPP protocols.
Key exclusion criteria (3 listed)
- Children taking psychotropic or other medication that will interact with target CYP 450 isoenzyme activity will not be eligible for the pharmacokinetic study (i.e. CYP2D6 or CYP3A4; to be decided by the PI)
- Patients with known renal or hepatic dysfunction (e.g. serum creatinine > 1.5 normal upper limit, transaminases or bilirubin > 2 times normal upper limit)
- Failure of the parent/legal guardian to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone | Drug | – |
Primary outcome
Quantify the variability of clearance and volume of distribution among AE rating, weight gain and ABC responder status.
1 secondary outcome
Exploratory analysis will be performed to examine the relationship of other factors to risperidone and metabolite concentrations for PK/PD assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
Related trials for Child Development Disorders, Pervasive
Recruiting
Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity.
ASD, Scoliosis Idiopathic Adolescent
RecruitingObservational study
The Neurodevelopmental and Behavioral Phenotyping Screening Protocol
Neurologic Disorders, Autism
RecruitingObservational study
Decoding Central Defects in Dystrophinopathies From Diagnostic to Remediation
Dystrophinopathies
Not yet recruitingObservational study
Risk Factors and Prognosis of Autism Spectrum Disorder
Autism Spectrum Disorder, Autistic Disorder
Recruiting
Social Robots and Board Games for Children With Autism Spectrum Disorder
Autism Spectrum Disorder, Child Development Disorders, Pervasive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Vinks, Pharm.D., Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Risperidone in people with Child Development Disorders, Pervasive, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify the variability of clearance and volume of distribution among AE rating, weight gain and ABC responder status.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012; AzTrials last refreshed its copy on 3 Nov 2026.