Clincosm LogoSign in Get a demo

PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics

Sponsor
Ulla Schierup Nielsen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05033119
Collaborator
North Denmark Region (Other), Central Denmark Region (Other), Mental Health Services in the Capital Region, Denmark (Other)
385
Enrollment
3
Locations
13
Anticipated Duration (Months)
128.3
Patients Per Site
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this study are:

  1. To determine the prevalence and degree of hyperprolactinemia in children and adolescents aged 7-18 years receiving antipsychotic medications

  2. To determine the associations between serum-prolactin and sex hormones / metabolic biomarkers/ clinical symptoms in this population. If clinically relevant associations are found: To determine a potentially existing "no harm" serum-prolactin threshold

  3. To determine associations between previous cumulative prolactin-exposure and current pubertal development / growth

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    385 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of hyperprolactinemia [2 years]

    Secondary Outcome Measures

    1. associations between serum-prolactin and sex hormones / metabolic biomarkers / clinical symptoms [2 years]

    2. associations between previous prolactin-exposure and current pubertal development / growth [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • • In daily treatment with antipsychotic medication belonging to Anatomical Therapeutic Chemical (ATC) group N05A (except N05AN lithium) for a minimum duration of 3 months prior to inclusion
    Exclusion Criteria:

    • Eating Disorder

    • Medical treatment to change sex

    • Pregnancy or lactation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Unit for Child and Adolescent Psychiatry, Aalborg University Hospital, Denmark Aalborg Denmark 9000
    2 Aarhus University Hospital Aarhus Denmark 8200
    3 Child and Adolescent Mental Health Center Capital Region, Denmark Copenhagen Denmark

    Sponsors and Collaborators

    • Ulla Schierup Nielsen
    • North Denmark Region
    • Central Denmark Region
    • Mental Health Services in the Capital Region, Denmark

    Investigators

    • Study Director: Ulla S Nielsen, Research Unit for Child and Adolescent Psychiatry, Aalborg,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ulla Schierup Nielsen, National Coordinating Principal Investigator, Aalborg Psychiatric Hospital
    ClinicalTrials.gov Identifier:
    NCT05033119
    Other Study ID Numbers:
    • N-20210029
    First Posted:
    Sep 2, 2021
    Last Update Posted:
    Sep 10, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hyperprolactinemia
    Metabolic Syndrome
    Disease
    Growth Disorders

    Study Results

    No Results Posted as of Sep 10, 2021