PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
NCT ID: NCT05033119
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
90 participants
OBSERVATIONAL
2021-11-01
2024-10-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Medical treatment to change sex
* Pregnancy or lactation
7 Years
18 Years
ALL
No
Sponsors
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North Denmark Region
OTHER_GOV
Central Denmark Region
OTHER
Mental Health Services in the Capital Region, Denmark
OTHER
Ulla Schierup Nielsen
OTHER
Responsible Party
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Ulla Schierup Nielsen
National Coordinating Principal Investigator
Principal Investigators
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Ulla S Nielsen
Role: STUDY_DIRECTOR
Research Unit for Child and Adolescent Psychiatry, Aalborg,
Locations
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Research Unit for Child and Adolescent Psychiatry, Aalborg University Hospital, Denmark
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Child and Adolescent Mental Health Center Capital Region, Denmark
Copenhagen, , Denmark
Countries
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Other Identifiers
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N-20210029
Identifier Type: -
Identifier Source: org_study_id
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