ClinicalTrials.gg
Sign In
CompletedNCT05033119PROSAUpdated Apr 30, 2026

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

An observational study in Hyperprolactinemia, Puberty Disorders and Metabolic Syndrome, sponsored by Ulla Schierup Nielsen. Completed at 3 sites in Denmark. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Ulla Schierup Nielsen · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
90
Ages
7 Years to 18 Years
Sex
All
01

Study 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
02

Conditions studied

  • Hyperprolactinemia
  • Puberty Disorders
  • Metabolic Syndrome
  • Growth Disorders
  • Antipsychotics and Neuroleptics Toxicity
03

In context

Hyperprolactinemia

39 studies on the registry are indexed under Hyperprolactinemia; 4 are open to participants now.

This study's enrollment of 90 is below the median of 114 across 16 observational studies indexed under Hyperprolactinemia.

Browse Hyperprolactinemia studies →

Lead sponsor

This is the only study on the registry with Ulla Schierup Nielsen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Eating Disorder
  • Medical treatment to change sex
  • Pregnancy or lactation
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
90 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Prevalence of hyperprolactinemia

    Time frame: 2 years

Secondary outcomes

  1. associations between serum-prolactin and sex hormones / metabolic biomarkers / clinical symptoms

    Time frame: 2 years

  2. associations between previous prolactin-exposure and current pubertal development / growth

    Time frame: 2 years

07

Study locations

3 sites
  • Research Unit for Child and Adolescent Psychiatry, Aalborg University Hospital, Denmark
    Aalborg, 9000, Denmark
  • Aarhus University Hospital
    Aarhus, 8200, Denmark
  • Child and Adolescent Mental Health Center Capital Region, Denmark
    Copenhagen, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2021 to primary completion in Dec 2024, 37 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2021
First posted
Sep 2, 2021
StartActual
Nov 1, 2021
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 31, 2024
Last update
Apr 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05033119
Lead sponsor
Ulla Schierup Nielsen
Collaborators
North Denmark Region, Central Denmark Region, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Responsible party
Ulla Schierup Nielsen (National Coordinating Principal Investigator, Aalborg University Hospital) — Sponsor-investigator
First posted
Sep 2, 2021
Start date
Nov 1, 2021
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Apr 30, 2026

Study contacts

Ulla S Nielsen
study director · Research Unit for Child and Adolescent Psychiatry, Aalborg,

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hyperprolactinemia →

Start the discussion