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

October 26, 2012 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
  • Germany
      • Freiburg, Germany
      • Jena, Germany
      • Mannheim, Germany
      • München, Germany
      • Tübingen, Germany
      • Ulm, Germany
      • Würzburg, Germany
  • Greece
      • Athens, Greece
  • Netherlands
      • Nijmegen, Netherlands
  • Poland
      • Gdansk, Poland
      • Kielce, Poland
      • Lódź, Poland
      • Sosnowiec, Poland
      • Warszawa, Poland
      • Warszawa N/A, Poland
  • United States
    • California
      • San Francisco, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Florida
      • Altamonte Springs, Florida, United States
      • Gainesville, Florida, United States
    • Georgia
      • Smyrna, Georgia, United States
    • Illinois
      • Naperville, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
      • Valparaiso, Indiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Cambridge, Massachusetts, United States
    • New York
      • Glen Oaks, New York, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Risperidone
Risperidone as per local prescribing practices
Drug: Risperidone
As per local prescribing practices
Experimental: Other atypical antipsychotic drugs
Other atypical antipsychotic drugs as per local prescribing practices
Drug: Other atypical antipsychotic drugs
As per local prescribing practices

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Height (cm) Z-score at Study Visit
Time Frame: One single study visit, approximately one week after informed consent has been obtained
Height (cm) measured at the study visit was converted to a Z-score based on the US Center for Disease Control 2000 growth charts for US subjects and European growth charts for ex-US subjects. A z-score indicates how many standard deviations a subject is away from the expected height for the subject's age and gender.
One single study visit, approximately one week after informed consent has been obtained

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age (Years) at Current Tanner Stage
Time Frame: One single study visit, approximately one week after informed consent has been obtained
Tanner stage is an evaluation of pubertal development with values ranging from 1 (pre-pubertal) to 5 (adult). A standardized, validated tool containing standardized pictures and written descriptions of the stages of pubic hair development, breast development for girls, and genital development for boys was used by physicians to make their assessment.
One single study visit, approximately one week after informed consent has been obtained
Number of Participants With Retrospectively Reported Potentially Prolactin-Related Adverse Events
Time Frame: Retrospectively during the time of exposure for up to 2 years prior to the study visit
Previous potentially prolactin-related adverse events, including hyperprolactinemia, were reviewed and abstracted from participants' medical records. Potentially prolactin-related adverse events include breast symptoms, menstrual disorders, hyperprolactinemia, and prolactinoma.
Retrospectively during the time of exposure for up to 2 years prior to the study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR016687
  • RISNAP4022 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings