Schizophrenia Clinical Trial
— PGD-RCTOfficial 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
Verified date | May 2015 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Department of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | November 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing Anding Hospital | Beijing | |
China | Department of Psychiatry, Queen Mary Hospital | Hong Kong | |
China | Department of Psychiatry, Kowloon Hospital | Kowloon | |
China | Xijing Hospital | Xian | Shanxi |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Capital Medical University, Kowloon Hospital, Hong Kong, Queen Mary Hospital, Hong Kong, Xijing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes from baseline serum prolactin levels at 8 weeks and 16 weeks | Serum concentrations of serum prolactin will be measured using chemiluminescent immunoassay (CLIA). | baseline, week 8 and week 16 | No |
Other | Changes from baseline serum estradiol levels at 8 weeks and 16 weeks | Serum concentrations of estradiol will be measured using chemiluminescent immunoassay (CLIA). | baseline, week 8 and week 16 | No |
Other | Changes from baseline serum testosterone levels at 8 weeks and 16 weeks | Serum concentrations of testosterone will be measured using chemiluminescent immunoassay (CLIA). | baseline, week 8 and week 16 | No |
Primary | 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) | baseline, week 8 and week 16 | No |
Primary | 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). | baseline, week 8 and week 16 | No |
Primary | 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. | baseline, week 8 and week 16 | No |
Primary | 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. | baseline, week 8 and week 16 | No |
Secondary | 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). | baseline, week 8 and week 16 | Yes |
Secondary | 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). | baseline, week 8 and week 16 | Yes |
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