Pediatric Population on Second Generation AntipsychoticsNCT02363816
Beta-carotene and Oxidative Stress in Pediatric Second Generation Antipsychotic Use
An observational study of Pediatric Population on Second Generation Antipsychotics, run by Wayne State University.
Trial summary
Weight gain, hypertension, high cholesterol and sugar abnormalities in childhood are strongly linked and predict the risk of further complications and early death in adulthood. The newer antipsychotics, called the second generation antipsychotics are commonly used to treat mood disorders in adult and pediatric… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Pediatric Population on Second Generation Antipsychotics
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2018
- Phase
- Observational
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric population treated with second generation antipsychotics
Who may be able to join
- Children aged 10 to 17 years currently treated with one or more antipsychotics as determined by a physician
- No changes in antipsychotic dosage for the past 6 weeks.
Who cannot join
- Guardian or child unwilling or unable to participate.
- A diagnosis of diabetes or dyslipidemia prior to starting an antipsychotic.
- Abuse or dependence diagnoses
About this study
Weight gain, hypertension, high cholesterol and sugar abnormalities in childhood are strongly linked and predict the risk of further complications and early death in adulthood. The newer antipsychotics, called the second generation antipsychotics are commonly used to treat mood disorders in adult and pediatric populations. Their use has substantially increased (up to 5-fold) in the past 15 years in children due to their approved use by the Food and Drug Administration and higher acceptance in the general medical community. However, second generation antipsychotics are known to have very damaging side effects that cause children to gain substantial amounts of weight, have high cholesterol, high blood pressure and high sugar levels. Despite the known risks their use is still needed and may be contributing to the high rates of obesity-related diseases in childhood and ultimately shorter life-spans in adulthood. How second generation antipsychotics cause these side effects is still not well known. Preliminary evidence has identified a novel pathway that may be associated with second generation antipsychotic side effects. This pathway has not been studied, is involved in vitamin A metabolism and is called the beta-carotene pathway. Beta-carotene is an important part of our diet because it acts as an anti-oxidant (fights harmful oxidative stress in the body) and it produces the active form of vitamin A which is essential for several processes in our body. The investigator's work has identified a backup in this pathway which the investigators hypothesize is due to genetic variation of the enzymes found within this pathway.
The investigators hypothesize that genetic variation in the beta-carotene pathway is responsible for the side effects associated with second generation antipsychotics. The investigators want to complete a cross-sectional, pilot study in the pediatric population that will be used for future prospective, extramural applications.
Read more
The investigators propose two aims for this study:
Aim 1: Determine how second generation antipsychotics change beta-carotene metabolism. For this aim, the investigators hypothesize that high beta-carotene:retinoic acid ratios will be due to genetic varition in the beta-carotene pathway.
Aim 2: Define the relationship between beta-carotene metabolism, oxidative stress and second generation antipsychotic induced insulin resistance. For this aim the investigators hypothesize that low beta-carotene levels will be associated with high oxidative stress levels and insulin resistance.
What is being measured
The primary outcome is the main question the study is designed to answer.
beta-carotene levels
serum level reported in mcg/dL
Measured: measured during cross-sectional visit
retinoic acid levels
serum level reported in nmol/L
Measured: measured during cross-sectional visit
Secondary outcomes (2)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Calculated by the following equation: [fasting insulin (pIU/mL) × fasting blood glucose (mmol/L)]/22.5
Measured: measured during cross-sectional visit
F2 Isoprostanes
peripheral biomaker of oxidative stress determined by ELISA in pg/ml
Measured: measured during cross-sectional visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Population on Second Generation AntipsychoticsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Burghardt, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363816
- Sponsor's protocol ID
- PEDSGAWSU
- Status last verified
- May 2016
- First submitted
- 28 Aug 2014
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-carotene and Oxidative Stress in Pediatric Second Generation Antipsychotic Use
- ClinicalTrials.gov ID
- NCT02363816
- Acronym / sponsor ID
- PEDSGAWSU
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 16 Feb 2015 (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.
Weight gain, hypertension, high cholesterol and sugar abnormalities in childhood are strongly linked and predict the risk of further complications and early death in adulthood. The newer antipsychotics, called the second generation antipsychotics are commonly used to treat mood disorders in adult and pediatric populations. Their use has substantially increased (up to 5-fold) in the past 15 years in children due to their approved use by the Food and Drug Administration and higher acceptance in the general medical community. However, second generation antipsychotics are known to have very damaging side effects that cause children to gain substantial amounts of weight, have high cholesterol, high blood pressure and high sugar levels. Despite the known risks their use is still needed and may be contributing to the high rates of obesity-related diseases in childhood and ultimately shorter life-spans in adulthood. How second generation antipsychotics cause these side effects is still not well known. Preliminary evidence has identified a novel pathway that may be associated with second generation antipsychotic side effects. This pathway has not been studied, is involved in vitamin A metabolism and is called the beta-carotene pathway. Beta-carotene is an important part of our diet because it acts as an anti-oxidant (fights harmful oxidative stress in the body) and it produces the active form of vitamin A which is essential for several processes in our body. The investigator's work has identified a backup in this pathway which the investigators hypothesize is due to genetic variation of the enzymes found within this pathway.
The investigators hypothesize that genetic variation in the beta-carotene pathway is responsible for the side effects associated with second generation antipsychotics. The investigators want to complete a cross-sectional, pilot study in the pediatric population that will be used for future prospective, extramural applications.
The investigators propose two aims for this study:
Aim 1: Determine how second generation antipsychotics change beta-carotene metabolism. For this aim, the investigators hypothesize that high beta-carotene:retinoic acid ratios will be due to genetic varition in the beta-carotene pathway.
Aim 2: Define the relationship between beta-carotene metabolism, oxidative stress and second generation antipsychotic induced insulin resistance. For this aim the investigators hypothesize that low beta-carotene levels will be associated with high oxidative stress levels and insulin resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric population treated with second generation antipsychotics
Key inclusion criteria (2 listed)
- Children aged 10 to 17 years currently treated with one or more antipsychotics as determined by a physician
- No changes in antipsychotic dosage for the past 6 weeks.
Key exclusion criteria (3 listed)
- Guardian or child unwilling or unable to participate.
- A diagnosis of diabetes or dyslipidemia prior to starting an antipsychotic.
- Abuse or dependence diagnoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
beta-carotene levels
Time frame: measured during cross-sectional visit
serum level reported in mcg/dL
retinoic acid levels
Time frame: measured during cross-sectional visit
serum level reported in nmol/L
2 secondary outcomes
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: measured during cross-sectional visit
F2 Isoprostanes
Time frame: measured during cross-sectional visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Population on Second Generation Antipsychotics, run by Wayne State University.
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 2 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: withdrawn, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
beta-carotene levels (time frame: measured during cross-sectional visit). The study lists 2 primary outcomes in all. 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 9 May 2016.