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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01050582
First received: January 14, 2010
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Bipolar Disorder
Autistic Disorder
Conduct and Other Disruptive Behavior Disorders
Drug: Risperidone
Drug: Other atypical antipsychotic drugs
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Height (cm) Z-score at Study Visit [ Time Frame: One single study visit, approximately one week after informed consent has been obtained ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Age (Years) at Current Tanner Stage [ Time Frame: One single study visit, approximately one week after informed consent has been obtained ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 244
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050582

  Show 29 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01050582     History of Changes
Other Study ID Numbers: CR016687, RISNAP4022
Study First Received: January 14, 2010
Results First Received: July 26, 2012
Last Updated: October 26, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia
Bipolar Disorder
Autistic Disorder
Conduct and Other Disruptive Behavior Disorders
Risperidone
RISPERDAL
Antipsychotic Agents
Prolactin
Pediatrics

Additional relevant MeSH terms:
Schizophrenia
Disease
Bipolar Disorder
Autistic Disorder
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes
Affective Disorders, Psychotic
Mood Disorders
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Risperidone
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014