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NCT05033119 Clinical Trial

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

Metabolic Syndrome Clinical Trial

— PROSA  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05033119
Other study ID # N-20210029
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date October 2024

Study information
Verified date July 2023
Source Aalborg University Hospital
Contact Ulla S Nielsen
Phone +4530289283
Email uni@rn.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 385
Est. completion date October 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark 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

Sponsors (4)
Lead Sponsor Collaborator
Ulla Schierup Nielsen Central Denmark Region, Mental Health Services in the Capital Region, Denmark, North Denmark Region

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of hyperprolactinemia 2 years
Secondary associations between serum-prolactin and sex hormones / metabolic biomarkers / clinical symptoms 2 years
Secondary associations between previous prolactin-exposure and current pubertal development / growth 2 years
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