Pediatric Population on Second Generation Antipsychotics Clinical Trial
| NCT number | NCT02363816 |
| Other study ID # | PEDSGAWSU |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | August 28, 2014 |
| Last updated | May 5, 2016 |
| Start date | January 2016 |
| Verified date | May 2016 |
| Source | Wayne State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 10 Years to 17 Years |
| Eligibility |
Inclusion Criteria: 1. Children aged 10 to 17 years currently treated with one or more antipsychotics as determined by a physician 2. No changes in antipsychotic dosage for the past 6 weeks. Exclusion Criteria: 1. Guardian or child unwilling or unable to participate. 2. A diagnosis of diabetes or dyslipidemia prior to starting an antipsychotic. 3. Abuse or dependence diagnoses |
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Wayne State University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | beta-carotene levels | serum level reported in mcg/dL | measured during cross-sectional visit | No |
| Primary | retinoic acid levels | serum level reported in nmol/L | measured during cross-sectional visit | No |
| Secondary | 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 during cross-sectional visit | No |
| Secondary | F2 Isoprostanes | peripheral biomaker of oxidative stress determined by ELISA in pg/ml | measured during cross-sectional visit | No |