Trials / Active Not Recruiting
Active Not RecruitingNCT05033119
PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (actual)
- Sponsor
- Ulla Schierup Nielsen · Academic / Other
- Sex
- All
- Age
- 7 Years – 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Hyperprolactinemia
- Puberty Disorders
- Metabolic Syndrome
- Growth Disorders
- Antipsychotics and Neuroleptics Toxicity
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2023-12-01
- Completion
- 2024-10-01
- First posted
- 2021-09-02
- Last updated
- 2024-08-12
Locations
3 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05033119. Inclusion in this directory is not an endorsement.