A Phase 2 interventional study of PGD granules and Placebo in Schizophrenia, Schizophrenic Disorder and Hyperprolactinemia, sponsored by The University of Hong Kong. Completed at 4 sites in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-05-07.
Sponsored by The University of Hong Kong · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Drug: PGD granules
While continuing current antipsychotic medications, subjects will receive adjunctive treatment with placebo granules. They need to take the placebo 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.
Drug: Placebo
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.
Changes from baseline Positive and Negative Syndrome Scale (PANSS) at 8 weeks and 16 weeks
The severity of psychotic symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS)
Time frame: baseline, week 8 and week 16
Changes from baseline Clinical Global Impression (CGI) score at 8 weeks and 16 weeks
The severity of psychotic symptoms will be assessed using the Clinical Global Impression (CGI).
Time frame: baseline, week 8 and week 16
Changes from baseline Simpson-Angus Rating Scale (SAS) at 8 weeks and 16 weeks
The Simpson-Angus Rating Scale (SAS) will be used to evaluate antipsychotic-induced abnormal involuntary movement symptoms.
Time frame: baseline, week 8 and week 16
Changes from baseline Abnormal involuntary movement scale (AIMS) at 8 weeks and 16 weeks
The abnormal involuntary movement scale (AIMS) will be used to evaluate antipsychotic-induced abnormal involuntary movement symptoms.
Time frame: baseline, week 8 and week 16
Change from baseline scores of Prolactin Related Adverse Event Questionnaire (PRAEQ) at 8 weeks and 16 weeks
Menstrual disturbances, breast symptoms and penile function will be assessed using the Prolactin Related Adverse Event Questionnaire (PRAEQ).
Time frame: baseline, week 8 and week 16
Change from baseline scores of Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU) at 8 weeks and 16 weeks
Other adverse effects will be assessed using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU).
Time frame: baseline, week 8 and week 16
Changes from baseline serum prolactin levels at 8 weeks and 16 weeks
Serum concentrations of serum prolactin will be measured using chemiluminescent immunoassay (CLIA).
Time frame: baseline, week 8 and week 16
Changes from baseline serum estradiol levels at 8 weeks and 16 weeks
Serum concentrations of estradiol will be measured using chemiluminescent immunoassay (CLIA).
Time frame: baseline, week 8 and week 16
Changes from baseline serum testosterone levels at 8 weeks and 16 weeks
Serum concentrations of testosterone will be measured using chemiluminescent immunoassay (CLIA).
Time frame: baseline, week 8 and week 16
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong