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

NCT05033119 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-04-30

No results posted yet for this study

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

Conditions

  • Hyperprolactinemia
  • Puberty Disorders
  • Metabolic Syndrome
  • Growth Disorders
  • Antipsychotics and Neuroleptics Toxicity

Sponsors & Collaborators

  • North Denmark Region

    collaborator OTHER_GOV

  • Central Denmark Region

    collaborator OTHER

  • Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

    collaborator OTHER

  • Ulla Schierup Nielsen

    lead OTHER

Principal Investigators

  • Ulla S Nielsen · Research Unit for Child and Adolescent Psychiatry, Aalborg,

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033119 on ClinicalTrials.gov