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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Subjects will only be included in the study sample if they meet all of the following criteria:
1. Boys and girls 8 to 16 years of age;
2. 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 subject must also assent;
3. Treated for schizophrenia, bipolar mania, autistic disorder, or conduct and other disruptive behavior disorders;
4. Had at least 6 months of exposure for an atypical antipsychotic drug within 24 months before the study visit; subjects may or may not be taking the atypical antipsychotics at the time of actual enrollment; eligible subjects can have exposure to multiple atypical antipsychotics. However, they cannot concomitantly be exposed to more than one atypical antipsychotic for a period of >30 days (to allow for cross-taper) (Section 12.2.);
5. Had medical records or automated data available for at least 1 year prior to the start of exposure;
6. Height and weight were recorded at least once within one 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

Subjects will be excluded from this study sample if they:
1. 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 (Section 12.3.);
2. Had exposure to prolactin elevating medications (Section 12.1.2.) other than atypical antipsychotics and selective serotonin reuptake inhibitors (SSRIs);
3. Had exposure to Paliperidone;
4. Cannot comply with study procedures.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objectives<br /><br>The primary objectives are<br /><br>* To evaluate the effects of risperidone as compared with other atypical<br /><br>antipsychotic medications on child growth and sexual maturation<br /><br>* To evaluate the risk of other prolactin-related adverse events<br /><br>associated with risperidone as compared with other atypical<br /><br>antipsychotic medications in a pediatric population</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective<br /><br>The secondary objective is to assess the prolactin value and risk of<br /><br>hyperprolactinemia associated with risperidone as compared with other<br /><br>atypical antipsychotic medications in a pediatric population.</p><br>