To estimate the prevalence of hyperprolactinemia in patients of psychotic disorders treated with atypical antipsychotics: a cross-sectional observational study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
Introduction: Psychotic disorders, such as schizophrenia and schizoaffective disorder, are chronic mental illnesses characterized by loss of contact with reality, often requiring long-term antipsychotic treatment. Atypical antipsychotics are widely used due to their better safety profile compared to typical antipsychotics; however, they are associated with significant adverse effects, such as hyperprolactinemia. Elevated serum prolactin levels can lead to various complications such as menstrual irregularities, galactorrhea, sexual dysfunction, infertility, and decreased bone mineral density.
Aim: The aim of this study is to estimate the prevalence of hyperprolactinemia in patients of psychotic disorders treated with atypical antipsychotics and to identify associated demographic and clinical correlates.
Material and Methods: A cross-sectional observational study will be conducted in patients of psychotic disorders who are receiving atypical antipsychotics for at least four weeks. This study will be conducted in the Department of Psychiatry at Government Medical College and Rajindra Hospital, Patiala. The patients who are eligible for the study will be enrolled after taking the written informed consent. After thorough history taking, individual information will be reported in case report form. A blood sample will be withdrawn to estimate serum T4, TSH and PRL levels. Lab reports will be collected and patients with hypothyroidism will be excluded. Data will be analyzed using appropriate statistical methods.
Clinical Significance: This study is expected to identify the prevalence of hyperprolactinemia among atypical antipsychotic users and provide insights into which agents are more associated with elevated prolactin levels. This will aid in better monitoring and management strategies to improve treatment adherence and quality of life in patients with psychotic disorders.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 to 65 years.
- •Diagnosed with a psychotic disorder (e.g., schizophrenia, schizoaffective disorder, delusional disorder) based on DSM-5 criteria.
- •On monotherapy or combination therapy with atypical antipsychotics for at least 4 weeks.
- •Willing to give informed consent and participate in the study.
排除标准
- •History of pituitary tumors, primary hypothyroidism (ruled out on the basis of T4 and TSH levels), and polycystic ovarian syndrome.
- •Concurrent use of medications known to elevate prolactin (e.g., metoclopramide, domperidone, verapamil, OCPs, opioids).
- •Pregnant or lactating females.
- •Patients with significant medical comorbidities (like CLD, CKD) that may interfere with hormonal regulation or lab testing.
- •Those unwilling or unable to give consent.
研究者
Dr Ishita
Government Medical College, Patiala