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

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

Non Recruiting
7-18 years
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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

Eligibility

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

Study details
    Hyperprolactinemia
    Puberty Disorders
    Metabolic Syndrome
    Growth Disorders
    Antipsychotics and Neuroleptics Toxicity

NCT05033119

Ulla Schierup Nielsen

20 August 2025

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