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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Herbal Medicine Peony-Glycyrrhiza Decoction (PGD) as an Adjunctive Therapy to Treat Antipsychotic-induced Hyperprolactinemia in Patients With Schizophrenia: a Double-b

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 Summary:

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.

Sponsor: The University of Hong Kong

Current Primary Outcome:

• Changes from baseline Positive and Negative Syndrome Scale (PANSS) at 8 weeks and 16 weeks [ Time Frame: baseline, week 8 and week 16 ]
  The severity of psychotic symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS)
• Changes from baseline Clinical Global Impression (CGI) score at 8 weeks and 16 weeks [ Time Frame: baseline, week 8 and week 16 ]
  The severity of psychotic symptoms will be assessed using the Clinical Global Impression (CGI).
• Changes from baseline Simpson-Angus Rating Scale (SAS) at 8 weeks and 16 weeks [ Time Frame: baseline, week 8 and week 16 ]
  The Simpson-Angus Rating Scale (SAS) will be used to evaluate antipsychotic-induced abnormal involuntary movement symptoms.
• Changes from baseline Abnormal involuntary movement scale (AIMS) at 8 weeks and 16 weeks [ Time Frame: baseline, week 8 and week 16 ]
  The abnormal involuntary movement scale (AIMS) will be used to evaluate antipsychotic-induced abnormal involuntary movement symptoms.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change from baseline scores of Prolactin Related Adverse Event Questionnaire (PRAEQ) at 8 weeks and 16 weeks [ Time Frame: baseline, week 8 and week 16 ]
  Menstrual disturbances, breast symptoms and penile function will be assessed using the Prolactin Related Adverse Event Questionnaire (PRAEQ).
• Change from baseline scores of Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU) at 8 weeks and 16 weeks [ Time Frame: baseline, week 8 and week 16 ]
  Other adverse effects will be assessed using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU).

Original Secondary Outcome: Same as current

Information By: The University of Hong Kong

Dates:
Date Received: May 6, 2013
Date Started: January 2013
Date Completion:
Last Updated: May 6, 2015
Last Verified: May 2015