The Effect of Hawthorn on Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Other: Hawthorn; Drug: SGAs

• Registration Number: NCT03663465
• Lead Sponsor: Calo Psychiatric Center

Brief Summary

Importance: The problems of side effects of metabolic disturbances in schizophrenic patients have been of worldwide concern for some time. Patients with dyslipidemia have an increased risk of cardiovascular diseases. A Chinese herb, Hawthorn, is widely used for the treatment of dyslipidemia.

Objective: Therefore, this study aimed to investigate the effect of Hawthorn on lipid profile levels in schizophrenic patients treated with antipsychotics.

Design, Setting, and Participants: A longitudinal case-control study was used in a general hospital in Taiwan. A total of 59 schizophrenics treated with antipsychotics, and 76 healthy adult subjects, who were all hospital workers, were enrolled in this study.

Main outcomes and measures: All participants received Hawthorn at a dose of 3 gm/day for six months.

Detailed Description

The problem of metabolic disturbances in schizophrenic patients who take antipsychotics has always been a cause for global concern and discussion. Although Hawthorn is widely used in the treatment of heart problems and the lowering of blood lipid levels, it is unknown whether Hawthorn has an effect in schizophrenic patients treated with antipsychotics. Hence, there are several areas of interest in the present study: 1) the effect of Hawthorn on lipid profile levels in schizophrenic patients treated with antipsychotics; 2) a comparison of lipid profile levels between schizophrenic patients and healthy adults; 3) the contributing factors that relate to changes in lipid profile levels in patients who take Hawthorn.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2013-12-31
• Study Completion: 2014-07-31
• Status Verified: 2018-09
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-06
• Last Update Submitted: 2018-09-06
• Study First Posted: 2018-09-10
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Patients in case group who had to meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
• All participants in the case group had previously received antipsychotic treatment for a period of time.

Exclusion Criteria

• Patients who had comorbid serious medical illnesses, and may therefore present substantial clinical risk due to pharmacotherapy, were excluded from the sample
• Participants were pregnant and lactating women in both group, were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hawthorn and SGAs	SGAs	SGAs has a dose of 3-20 gm/day, Hawthorn at a dose of 3 gm/day for six months.
Hawthorn	Hawthorn	Hawthorn at a dose of 3 gm/day for six months.
Hawthorn and SGAs	Hawthorn	SGAs has a dose of 3-20 gm/day, Hawthorn at a dose of 3 gm/day for six months.

Primary Outcome Measures

Name	Time	Method
lipid profiles	three days	lipid profiles (including TC, TG, HDL, LDL) were collected three times (at first week, 12th week and 24th week. Total collecting day were three days.