ITMCTR2100005194招募中1 期
Efficacy and safety of Peony-Glycyrrhiza Decoction in the treatment for Antipsychotic-Related Hyperprolactinemia in patients with schizophrenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 55(—)
- 性别
- All
入选标准
- •?This study protocol was approved by the the ethic committee of Shandong Mental Health Center, all participants and their guardians were given the voluntary, written, and informed consent before entering the trial
- •?In this study, female participants aged 18-45 years with diagnosis of schizophrenia (according to DSM-IV) were screened. All patients ensured that they should use single antipsychotic therapy, the type and dosage of antipsychotics remained unchanged, keeping the dosage fixed at least 3 months.
- •?meet hyperprolactinaemia diagnostic criteria: serum prolactin level greater than 24 ng/ml.
- •?stable clinical symptom: Positive and negative syndrome scale score is equal or less than 70.
- •?at least 1 overt hyperprolactin-related symptom, including amenorrhea, oligomenorrhea, irregular menstruation, galactorrhea, hyposexuality, sexlessness.
排除标准
- •?A history of substance dependence or psychotic symptoms caused by another mental illness;
- •?Antipsychotic malignant syndrome or tardive dyskinesia.
- •?Have brain trauma, epilepsy or other organic brain disease
- •?Suicidal attempts or thoughts or acts of suicide
- •?Prolactinoma, polycystic ovary syndrome or other serious physical diseases and metabolic disorders;
- •?History of alcohol or substance abuse in the past year;
- •?taking endocrinology medicines or Chinese medicines or other natural medicines;
- •?Pregnant or breastfeeding patients.
研究者
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