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

July 24, 2023 updated by: Ulla Schierup Nielsen

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ulla S Nielsen
  • Phone Number: +4530289283
  • Email: uni@rn.dk

Study Contact Backup

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Research Unit for Child and Adolescent Psychiatry, Aalborg University Hospital, Denmark
        • Contact:
          • Ulla S Nielsen
          • Phone Number: +4530289283
          • Email: uni@rn.dk
        • Sub-Investigator:
          • Morten B Thorsen
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Karen Kallesøe
        • Contact:
          • Piotr Machowski
      • Copenhagen, Denmark
        • Recruiting
        • Child and Adolescent Mental Health Center Capital Region, Denmark
        • Contact:
          • Anne-Katrine Pagsberg
        • Contact:
          • Louise B Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of hyperprolactinemia
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
associations between serum-prolactin and sex hormones / metabolic biomarkers / clinical symptoms
Time Frame: 2 years
2 years
associations between previous prolactin-exposure and current pubertal development / growth
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulla Schierup Nielsen

Collaborators

Central Denmark Region
Mental Health Services in the Capital Region, Denmark
North Denmark Region

Investigators

  • Study Director: Ulla S Nielsen, Research Unit for Child and Adolescent Psychiatry, Aalborg,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20210029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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