Status:
COMPLETED
Evaluate the Quality of Life and Treatment of Anxiety Symptoms of Buspirone in Patients With Depression Disorders(BASIS)
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Depressive Disorder, Major
Anxiety Disorders
Eligibility:
All Genders
19+ years
Brief 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) anti...
Detailed 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 bein...
Eligibility Criteria
Inclusion
- Patients who have voluntarily signed the instruction and consent form for the use of personal information
- Adults over 19 years of age
- Patients diagnosed with Depressive disorders according to the DSM-5 criteria
- Patients with a HAM-A score of 18 or higher on the date of enrollment
- Patients taking an SSRI or SNRI antidepressant at an effective dose or higher for 4 weeks or longer whose symptoms of anxiety are being additionally treated with Buspar® Tab (Buspirone)
- Patients with the ability to read and understand self-rated scales
Exclusion
- Patients listed in the contraindication group for Buspar® Tab (Buspirone)
- Patients administered an azapirone class of anxiolytics including buspirone during the last 4 weeks
- Patients administered a benzodiazepine class of anxiolytics for the first time or with a dose change during the last 1 weeks
- Patients administered a psychostimulant or medication for attention deficit hyperactivity disorder (ADHD) during the last 4 weeks
- Pregnant or lactating women
- Subjects participating in another clinical trial or taking an investigational product for another clinical trial within 12 weeks after the screening visit (Visit 1)
- Patients determined by the Investigator to be at risk of suicide, self-harm, or hurting others
- Other subjects determined to be unsuitable by the Investigator
Key Trial Info
Start Date :
February 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04770454
Start Date
February 8 2021
End Date
March 30 2023
Last Update
June 15 2023
Active Locations (1)
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1
the Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Yeouido, South Korea, 03127