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

Ulla Schierup Nielsen

Status: Active, not recruiting

Conditions: Growth Disorders; Antipsychotics and Neuroleptics Toxicity; Puberty Disorders; Metabolic Syndrome; Hyperprolactinemia

Study type: Observational

Funder types: Other

Identifiers

NCT05033119

N-20210029

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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