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

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.

Conditions

• Schizophrenia
• Schizophrenic Disorder
• Hyperprolactinemia
• Hyperprolactinaemia

Interventions

DRUG

PGD granules

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.

DRUG

Placebo

The placebo granules are prepared to be identical to PGD granules in smell, taste and color.

Sponsors & Collaborators

• Kowloon Hospital, Hong Kong

  collaborator OTHER

• Queen Mary Hospital, Hong Kong

  collaborator OTHER

• Capital Medical University

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Zhang-Jin Zhang, MMed, PhD · School of Chinese Medicine, The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2014-04-30

Completion

2014-11-30

Countries

• China

Study Locations