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

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

Completed

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Key information

Conditions

Hyperprolactinemia Antipsychotics and Neuroleptics Toxicity Brain Diseases Central Nervous System Diseases Endocrine System Diseases Glucose Metabolism Disorders Growth Disorders Hyperinsulinism Hyperpituitarism Hypothalamic Diseases Insulin Resistance Metabolic Diseases Metabolic Syndrome Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Puberty Disorders

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Unit for Child and Adolescent Psychiatry, Aalborg University Hospital, Denmark, Aalborg, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Prevalence of hyperprolactinemia

Time frame: 2 years

Secondary outcomes

associations between serum-prolactin and sex hormones / metabolic biomarkers / clinical symptoms

Time frame: 2 years
associations between previous prolactin-exposure and current pubertal development / growth

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Ulla Schierup Nielsen

Other

Collaborators

Central Denmark Region
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
North Denmark Region

Registry information

Acronym: PROSA

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Sep 2, 2021
Registry last updated: Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed