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

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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