Viewing Study NCT01852331



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Last Modification Date: 2024-10-26 @ 11:06 AM
Study NCT ID: NCT01852331
Status: COMPLETED
Last Update Posted: 2015-05-07
First Post: 2013-05-06

Brief Title: Peony-Glycyrrhiza Decoction PGD for Antipsychotic-induced Hyperprolactinemia in Patients With Schizophrenia
Sponsor: The University of Hong Kong
Organization: The University of Hong Kong

Study Overview

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
Status: COMPLETED
Status Verified Date: 2015-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PGD-RCT
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 07-11 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None