Brief Title
Peony-Glycyrrhiza Decoction (PGD) for Antipsychotic-induced Hyperprolactinemia in Patients With Schizophrenia
Official Title
The Herbal Medicine Peony-Glycyrrhiza Decoction (PGD) as an Adjunctive Therapy to Treat Antipsychotic-induced Hyperprolactinemia in Patients With Schizophrenia: a Double-blind, Randomized, Placebo-controlled Study
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 antipsychotic-induced elevation of PRL levels.
This is a placebo-controlled trial conducted in schizophrenic patients to determine whether
PGD adjunctive treatment could produce greater biochemical and clinical improvement on
hyperprolactinemia (hyperPRL) compared to placebo treatment.
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 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, which may be a greater risk than hyperPRL
itself.
Chinese herbal medicine called Peony-Glycyrrhiza Decoction (PGD) has been widely introduced
into the treatment of various conditions associated with hyperPRL in China and Japan. In our
series of in-vitro experience it was found that PGD can significantly suppress PRL
concentration in the cultured medium in a dose-dependent manner. Our recent open-labelled
pilot study demonstrated that PGD significantly suppressed risperidone-induced elevation of
blood PRL levels and produced a greater improvement on hyperPRL-related symptoms compared to
dopamine agonist bromocriptine. Empirical and experimental evidence also confirmed that PGD
and its individual herbal preparations possess a high safety profile.
The encouraging results obtained from our laboratory and clinical pilot studies, together
with findings of previous studies, have warranted an extensive controlled trial to further
determine PGD as an effective therapy for the treatment of antipsychotic-induced hyperPRL.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Changes from baseline Positive and Negative Syndrome Scale (PANSS) at 8 weeks and 16 weeks
Secondary Outcome
Change from baseline scores of Prolactin Related Adverse Event Questionnaire (PRAEQ) at 8 weeks and 16 weeks
Condition
Schizophrenia
Intervention
PGD granules
Study Arms / Comparison Groups
PGD granules
Description: While continuing current antipsychotic medications, subjects will receive adjunctive Peony-Glycyrrhiza Decoction (PGD) granules (equivalent to 45 g raw materials in total per day). They need to take the granules two times a day, each time one sachet (aluminum foil pack of 9g, tear open and empty contents into a cup, add 200ml hot water, stir until dissolute completely, and drink the preparation when warm), for a consecutive of 16 weeks.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
103
Start Date
January 2013
Completion Date
November 2014
Primary Completion Date
April 2014
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.
Gender
Female
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Zhang-Jin Zhang, MMed, PhD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01852331
Organization ID
UW 11-274
Responsible Party
Principal Investigator
Study Sponsor
The University of Hong Kong
Collaborators
Kowloon Hospital, Hong Kong
Study Sponsor
Zhang-Jin Zhang, MMed, PhD, Principal Investigator, School of Chinese Medicine, The University of Hong Kong
Verification Date
May 2015