Official Title: “Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs”

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

Study Type: Observational

Study Design: Observational Model: Cohort, Time Perspective: Cross-Sectional

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

Intervention(s) in this Clinical Trial

• Drug: Risperidone
  • As per local prescribing practices
• Drug: Other atypical antipsychotic drugs
  • As per local prescribing practices

Arms, Groups and Cohorts in this Clinical Trial

• : 001
  • Risperidone As per local prescribing practices
• : 002
  • Other atypical antipsychotic drugs As per local prescribing practices

Primary Measures

• 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.
  • Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit
    Safety Issue?: Yes

Secondary Measures

• Assess the prolactin value and risk of hyperprolactinemia associated with risperidone as compared with other atypical antipsychotic medications in a pediatric population.
  • Time Frame: One time during the study visit
    Safety Issue?: Yes
• Identification of subgroups of patients at high risk for changes in height or maturation.
  • Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Overall Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:  info1@veritasmedicine.com

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01050582

Study ID Number: CR016687

ClinicalTrials.gov Identifier: NCT01050582

Health Authority: United States: Institutional Review Board

To learn how to participate in this trial please click here.