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

NCT05033119 | Completed DMC

• 1 other identifier: N-20210029
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

The objectives of this study are:

1. 1.To determine the prevalence and degree of hyperprolactinemia in children and adolescents aged 7-18 years receiving antipsychotic medications
2. 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. 3.To determine associations between previous cumulative prolactin-exposure and current pubertal development / growth

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of hyperprolactinemia

  2 years

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All outpatients aged 7-18 years receiving treatment with antipsychotics at the Department of Child and Adolescent Psychiatry, Aalborg University Hospital, the Department of Child and Adolescent Psychiatry, Aarhus University Hospital and at the Child and Adolescent Mental Health Center, Copenhagen University Hospital, Capital Region will be invited to participate in the study.

You may not qualify if:

• Eating Disorder
• Medical treatment to change sex
• Pregnancy or lactation

Sponsors & Collaborators

• Ulla Schierup Nielsen: lead
• North Denmark Region: collaborator
• Central Denmark Region: collaborator
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator

Study Sites (3)

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

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Child and Adolescent Mental Health Center Capital Region, Denmark

Copenhagen, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Hyperprolactinemia; Metabolic Syndrome; Growth Disorders

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulla S Nielsen

  Research Unit for Child and Adolescent Psychiatry, Aalborg,

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: National Coordinating Principal Investigator

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)