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Evaluate the Quality of Life and Treatment of Anxiety Symptoms of Buspirone in Patients With Depression Disorders(BASIS) — BASIS  

Anxiety Disorders Clinical Trial

Official title:
A Multicenter, Prospective, Non-interventional Observational Study to Evaluate the Quality of Life and Treatment of Anxiety Symptoms of Buspar® Tab (Buspirone) in Patients With Depression Disorder in Korea

Clinical Trial Summary

Approximately 20 sites in Korea including the Catholic University of Korea, Yeouido St. Mary's Hospital. Patients with Depressive disorders taking a selective serotonin reuptake inhibitor (SSRI) antidepressant or Serotonin and norepinephrine reuptake inhibitor (SNRI), who additionally administered Buspar® Tab (Buspirone) to control symptom of anxiety. Primary objective: To evaluate the efficacy of treating the symptoms of anxiety at 12 weeks from the baseline after the administration of Buspar® Tab (Buspirone) to patients with depression by using the Hamilton Anxiety (HAM-A). Approximately 400 participants (including 10% dropouts) Rating Scale

Clinical Trial Description

In this study, necessary data will be collected by history taking and medical record review of patients who are taking an SSRI or SNRI antidepressant in the clinical practice and at the same time being additionally administered Buspar® Tab (Buspirone) for the treatment of symptoms of anxiety. Encourage outpatients with depression accompanied by symptoms of anxiety visiting medical centers in Korea to participate in this study and obtain voluntary consent from them. Have the patients sign the instruction and informed consent form for the use of personal information and enroll them if they meet the inclusion/exclusion criteria. Collect the following data in the case report form (CRF) during the 12-week follow-up observation period. The HAM-A, HAM-D, and CGI-S are measured at the baseline and at 4, 8, and 12 weeks. The CGI-I is measured at 4, 8, and 12 weeks, and the SDS and WHO-5 are measured at the baseline and at 12 weeks. The following data regarding all the subjects enrolled in this study are collected in the CRF during the 12-week follow-up observation period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04770454
Study type Observational
Source Boryung Pharmaceutical Co., Ltd
Contact
Status Completed
Phase
Start date February 8, 2021
Completion date March 30, 2023
View Details
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