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

N/AActive Not RecruitingNCT05033119

Ulla Schierup Nielsen90 enrolled

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hyperprolactinemia Puberty Disorders Metabolic Syndrome Growth Disorders Antipsychotics and Neuroleptics Toxicity

Eligibility

Sex: ALLMin age: 7 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

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