A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
Condition: Schizophrenia; Bipolar Disorder; Autistic Disorder; Conduct and Other Disruptive Behavior Disorders
MeSH terms: Schizophrenia; Bipolar Disorder; Autistic Disorder; Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effects of risperidone compared with other
      atypical antipsychotic drugs on the physical maturity, growth and development of children,
      and the risk of prolactin-related adverse events (side effects) associated to these drugs.
    

Detailed description: 
      This is a 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 second group of children and adolescents will either be currently taking
      or have recently been treated with an a similar type of atypical antipsychotic therapy. 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. Each patient will
      participate in the study for about one week. The 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.
    

Intervention name(s): Risperidone; Other atypical antipsychotic drugs
Intervention type(s): Drug; Drug
Intervention description(s): As per local prescribing practices; As per local prescribing practices
Intervention MeSH terms: Risperidone; Antipsychotic Agents
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Bipolar Disorder; Autistic Disorder; Conduct and Other Disruptive Behavior Disorders; Risperidone; RISPERDAL; Antipsychotic Agents; Prolactin; Pediatrics