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Search / Trial NCT01852331

Peony-Glycyrrhiza Decoction (PGD) for Antipsychotic-induced Hyperprolactinemia in Patients With Schizophrenia

Launched by THE UNIVERSITY OF HONG KONG · May 10, 2013

Trial Information

Current as of June 07, 2025

Completed

Keywords

Schizophrenia Schizophrenic Disorder Hyperprolactinemia Hyperprolactinaemia Chinese Herbal Medicine Traditional Chinese Medicine Peony Glycyrrhiza Decoction Pgd Glycyrrhiza Radix Liquorice Root Gancao Paeoniae Alba Radix White Peony Root Baishao

ClinConnect Summary

Schizophrenia is a severe mental illness that affects 0.7-1.1% of the worldwide population. Most patients who develop a chronic course with frequent relapses and exacerbation of psychosis are required to have long-term treatment. The clinical outcomes of antipsychotic pharmacotherapy are limited, largely due to various adverse side effects. Hyperprolactinemia (hyperPRL) is the most challenging among them. Dopamine agonists may be used for hyperPRL if it does not improve after the reduction of antipsychotic doses. However, this may aggravate psychosis and abnormal involuntary movements, whic...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • have a primary diagnosis of schizophrenia or schizoaffective disorder based on International Classification of Diseases (10th edition);
  • under antipsychotic medications for at least three months and current conditions are stable, indicated by no difficulty to communicate with investigators and give informed consent;
  • have developed at least one overt hyperPRL-associated symptom, including oligomenorrhoea (infrequent, irregularly timed episodes of bleeding occurring at intervals of more than 35 days from the previous menstrual cycle), amenorrhoea (the absence of menstruation for three menstrual cycles or 6 months), galactorrhea, decreased libido, anorgasmia or erectile dysfunction; and
  • serum PRL levels are \>24 ng/ml (or 1043.472 pmol/l) in female or \>19 ng/ml (or 826.082 pmol/l) in male.
  • Exclusion Criteria:
  • unstable medical conditions;
  • suicidal ideas or attempts or aggressive behavior;
  • history of alcoholism in the past one year, characterized by compulsive and uncontrolled consumption of alcohol, despite the realization of its negative effects on health, relationship, and social standing;
  • history of drug abuse in past one year;
  • currently treated with Chinese medicine or other natural products;
  • allergic history of herbal medicine;
  • pre-existing hyperPRL symptoms not associated with antipsychotic treatment; and
  • pregnant and lactating women and those who refuse to use contraception during the study.

About The University Of Hong Kong

The University of Hong Kong (HKU) is a leading research institution dedicated to advancing medical knowledge and improving healthcare outcomes through innovative clinical trials. With a commitment to excellence in research and education, HKU collaborates with various stakeholders, including healthcare providers and industry partners, to conduct rigorous and ethically sound clinical studies. The university's diverse expertise and state-of-the-art facilities enable it to explore a wide range of therapeutic areas, contributing to the global pursuit of scientific advancement and the development of novel treatment strategies.

Locations

Beijing, , China

Xian, Shanxi, China

Hong Kong, , China

Kowloon, , China

Patients applied

0 patients applied

Trial Officials

Zhang-Jin Zhang, MMed, PhD

Principal Investigator

School of Chinese Medicine, The University of Hong Kong

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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