Status:
COMPLETED
Peony-Glycyrrhiza Decoction (PGD) for Antipsychotic-induced Hyperprolactinemia in Patients With Schizophrenia
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Kowloon Hospital, Hong Kong
Queen Mary Hospital, Hong Kong
Conditions:
Schizophrenia
Schizophrenic Disorder
Eligibility:
FEMALE
18-60 years
Phase:
PHASE2
Brief Summary
The investigators hypothesize that Peony-Glycyrrhiza Decoction (PGD) adjunctive therapy could reduce the incidence of prolactin (PRL)-related adverse events in patients with schizophrenia and suppress...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01852331
Start Date
January 1 2013
End Date
November 1 2014
Last Update
May 7 2015
Active Locations (4)
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1
Xijing Hospital
Xian, Shanxi, China, 710032
2
Beijing Anding Hospital
Beijing, China, 100088
3
Department of Psychiatry, Queen Mary Hospital
Hong Kong, China
4
Department of Psychiatry, Kowloon Hospital
Kowloon, China