Antipsychotics and Neuroleptics Toxicity, Growth Disorders, Hyperprolactinemia, Metabolic Syndrome, Puberty Disorders
Conditions
Brief 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
Interventions
None listed
Sponsors
Ulla Schierup Nielsen
North Denmark Region
Central Denmark Region
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of hyperprolactinemia | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark
Contacts
STUDY_DIRECTORUlla S Nielsen
Research Unit for Child and Adolescent Psychiatry, Aalborg,
Outcome results
None listed