Peony-Glycyrrhiza Decoction (PGD) for Antipsychotic-induced Hyperprolactinemia in Patients With Schizophrenia
Condition: Schizophrenia; Schizophrenic Disorder; Hyperprolactinemia; Hyperprolactinaemia
MeSH terms: Hyperprolactinemia; Schizophrenia
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): PGD granules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The preparation of Peony-Glycyrrhiza Decoction (PGD) granules is in compliance with Pharmacopoeia of the People's Republic of China and Good Manufacturing Practice (GMP). Briefly, sliced, broiled Paeoniae Alba Radix and Glycyrrhizae Radix in a ratio of 1:1 in weight will be immersed and boiled in an 8-fold volume of distilled water for 2.5 hours. This process will be repeated twice. The extract solution will be pooled and concentrated into granule form. Weight of the resulting granules contained in two 9g-sachet packs (to be taken in one day) is equivalent to 45 g raw herbal materials which are supplied for one day.; The placebo granules are prepared to be identical to PGD granules in smell, taste and color.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
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