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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborators: Capital Medical University; Kowloon Hospital, Hong Kong; Queen Mary Hospital, Hong Kong; Xijing Hospital
• Treatments: Antipsychotic Agents

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.