NCT05033119已完成不适用
PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
Ulla Schierup Nielsen5 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Prevalence of hyperprolactinemia
研究概览
简要总结
The objectives of this study are:
- To determine the prevalence and degree of hyperprolactinemia in children and adolescents aged 7-18 years receiving antipsychotic medications
- 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
- To determine associations between previous cumulative prolactin-exposure and current pubertal development / growth
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •Eating Disorder
- •Medical treatment to change sex
- •Pregnancy or lactation
结局指标
主要结局
Prevalence of hyperprolactinemia
时间窗: 2 years
次要结局
- 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)
研究者
Ulla Schierup Nielsen
National Coordinating Principal Investigator
Aalborg University Hospital
研究点 (5)
Loading locations...
相似试验
终止
不适用
Hyperprolactinemia and Adrenal SteroidogenesisHyperprolactinemiaNCT04146389Insel Gruppe AG, University Hospital Bern5
已完成
不适用
Characterization of MacroprolactinemiaHyperprolactinemiaNCT00436111Kansai Medical University
撤回
不适用
Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After TreatmentInsulin ResistanceHyperprolactinemiaNCT00699530University of Aarhus
已完成
不适用
Prolactin Receptor and Breast DiseasesBenign Breast DiseaseBreast CancerNCT00842465Assistance Publique - Hôpitaux de Paris735
撤回
2 期
Recombinant Human Prolactin for Lactation InductionLactationNCT00181649Massachusetts General Hospital