Efficacy and safety of Peony-Glycyrrhiza Decoction in the treatment for Antipsychotic-Related Hyperprolactinemia in patients with schizophrenia

Phase 1

Recruiting

• Conditions: Schizophrenia

• Registration Number: ITMCTR2100005194
• Lead Sponsor: Shandong Mental Health Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

?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.

Exclusion Criteria

?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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
luteinizing hormone;testosterone;follicle-stimulating hormone;prolactin;progesteron;estradiol;