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

Active, not recruiting

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

• Registration Number: NCT05033119
• Lead Sponsor: Ulla Schierup Nielsen

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-02
• Study Start: 2021-11-01
• Primary Completion: 2023-12-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of hyperprolactinemia	2 years

Secondary Outcome Measures

Name	Time	Method
associations between serum-prolactin and sex hormones / metabolic biomarkers / clinical symptoms	2 years
associations between previous prolactin-exposure and current pubertal development / growth	2 years

Trial Locations

Locations (3)

Child and Adolescent Mental Health Center Capital Region, Denmark; 🇩🇰 Copenhagen, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

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