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View Clinical Trial (Medical Research Study)
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An Observational Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children - NCT01050582- (Clinical Trial 465287)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy465287.aspx
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| City: |
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Glen Oaks |
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State:
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NY |
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| Conditions: |
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Schizophrenia - Bipolar Disorder - Autistic Disorder - Attention Deficit and Disruptive Behavior Disorders |
| Purpose: |
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The purpose of this observational study is to evaluate risk of prolactin-related adverse
events (side effects) and the effects of risperidone compared with other atypical
antipsychotic drugs on the physical maturity, growth and development of children exposed to
these drugs
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| Study summary: |
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This is a noninterventional (study drug will not be provided to patients) study to find out
what the effects are of long-term use of atypical antipsychotics (drugs used to treat mental
health and some behavior disorders) in children and adolescents on their growth and physical
maturity. Atypical antipsychotics are used in the treatment of a wide range of disorders in
children and adolescents, such as; schizophrenia, bipolar mania, autistic disorder or other
disruptive behavior disorders. This study does not involve using any new medication, but to
look into some of the side effects that children and adolescents may experience from taking
an atypical antipsychotic. One of the side effects of some atypical antipsychotics is an
increased level of "prolactin", a hormone that occurs naturally in the body which can lead
to "hyperprolactinemia" a condition in which the pituitary gland produces too much
prolactin. In order to further investigate these possible side effects, two groups of
children and adolescents (aged 8 to 16) with a diagnosis of; schizophrenia, bipolar mania,
autistic disorder, or conduct and other disruptive behavior disorders who are or have been
recently treated with an atypical antipsychotic will be enrolled; 1 group of children and
adolescents will either be currently taking or have recently been treated with risperidone
and the 2nd group of children and adolescents will either be currently taking or have
recently been treated with an a similar type of atypical antipsychotic therapy. A total of
about 350 participants will be enrolled; 175 participants in each of 2 groups. The results
will then be compared to see if the age of physical maturation, growth and development
differs between the two groups, using data collected during an office visit and previous
information available from existing medical records. The patient's growth will be assessed
using information on height and weight taken from the medical records at different time
points before (up to one year previous) and since they started treatment with antipsychotic
therapy. In addition, there will also be one visit to the clinic where the growth and stage
of sexual maturity of the patient will be reviewed by both the study doctor and through the
patient's own assessment, using a questionnaire and pictures developed specially to assess
stages of physical development (so called - Tanner stage). In addition, one blood sample
will be taken from each patient to check the levels of prolactin hormone in the blood to see
if this differs between treatment groups. Potential patients will be identified through
automated databases and/or medical chart review. If, after fully understanding the purpose
of this study, the parent, legal guardian and their child agree to participate by signing an
informed consent (children to sign an assent form), information (specified below) related to
your child's treatment and development will be collected directly from central medical
records or from notes kept by your child's doctor for evaluation. The following data will be
collected from available medical records: information about the patient's use of
antipsychotic drug and prescriptions; previous records of the patient's height, weight, and
growth; physical and sexual development (so called, Tanner stage [developmental stage]) if
available; results of previous blood tests taken to evaluate the level of the hormone
prolactin if available; and, history of any side effects that could be related to increased
levels of the hormone prolactin. All the above information will be collected within 1 year
before the patient started antipsychotic therapy. The same information (if available) will
also be collected following the time that the patient starting taking their atypical
antipsychotic medication until the present time. As much information as possible will be
collected for this period of time so that a determination of how taking antipsychotic drugs
may have influenced the patient's growth can be made. The study doctor will see each patient
for a single study visit. This visit will take place at a convenient time approximately one
week after informed consent/assent has been obtained. At the clinic visit, the study doctor
will do some examinations to check the patient's general health and assess their growth and
physical development. These will include: a physical examination (including developmental
stage assessment [Tanner stage]), weight and height, vital signs (pulse, respiration rate,
temperature and blood pressure), medical history, and the collection of information
regarding the occurrence of any side effects thought to be related to the use of atypical
antipsychotic medication or related to the hormone prolactin. In addition to being assessed
by the study doctor, the patient will be asked to complete the Tanner Stage questionnaire.
This will involve the patient reviewing both pictures and written descriptions of children
at different stages of physical development. The patient will have to decide which
picture/description is most representative of their body. The study doctor will also look at
the patient's current use of any other medications. A single blood sample (up to 5 ml or
about one teaspoonful) will be taken from the patient to look at the level of a hormone
called "prolactin." Each patient will participate in the study for about one week. The
primary outcome measures of the study will be to compare Z-scores for height, age at current
Tanner stage, and prolactin-related adverse events between patients exposed to risperidone
and patients exposed to other atypical antipsychotic drugs. Outcome measures will be
collected during the study visit and retrospectively during the time of exposure for up to 2
years prior to the study visit. Observational study - No investigational drug administered |
| Criteria: |
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Inclusion Criteria:
- One or both parents (according to local regulations) or a guardian must have signed
an informed consent document indicating that they understand the purpose of and
procedures required for the study and are willing to participate in the study (If
appropriate according to local regulations, the patient must also assent)
- Treated for schizophrenia, bipolar mania, autistic disorder, or conduct and other
disruptive behavior disorders
- Had at least 6 months of exposure for an atypical antipsychotic drug within 24 months
before the study visit (patients may or may not be taking the atypical antipsychotics
at the time of actual enrollment, eligible patients can have exposure to multiple
atypical antipsychotics, however, they cannot concomitantly be exposed to more than 1
atypical antipsychotic for a period of greater than 30 days)
- Had medical records or automated data available for at least 1 year prior to the
start of exposure
- Height and weight were recorded at least once within 1 year before the start of
exposure, and if available at any time points after the start of exposure in the
medical records or electronic databases (not mandatory)
Exclusion Criteria:
- Have at least 1 medical record, at any time before the start of exposure, consistent
with malignancy (other than non-melanoma skin cancer), pregnancy, or a developmental
delay or abnormality associated with growth or sexual maturation delays not related
to the specified indications
- Had exposure to prolactin elevating medications other than atypical antipsychotics
and selective serotonin reuptake inhibitors (SSRIs)
- Had exposure to Paliperidone
- Cannot comply with study procedures |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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