Schizophrenia Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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