A Multicenter, Prospective, OS to Evaluate the Quality of Life and Treatment of Anxiety Symptoms of Buspirone in Patients With Depression Disorders in Korea (BASIS)
Study Details
Study Description
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) 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 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
Outcome Measures
Primary Outcome Measures
- Hamilton Anxiety Rating Scale (HAM-A) score [at 12 weeks]
change from baseline in HAM-A score at week 12 The scale consists of 14 items designed to assess the severity of a patient's anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe. All of these scores are used to compute an overarching score that indicates a person's anxiety severity.
Secondary Outcome Measures
- Hamilton Anxiety Rating Scale (HAM-A) score [at 4 and 8 weeks]
change from baseline in HAM-A score at week 4,8
- Hamilton Depression Rating Scale (HAM-D) score [at 4, 8, and 12 weeks]
change from baseline in HAM-D score at week 4,8 and 12
- Clinical Global Impression Scale-Severity(CGI-S) [at 4, 8, and 12 weeks]
change from baseline in CGI-S score at week 4,8 and 12
- Clinical Global Impression Scale-Improvement(CGI-I) [at 4, 8, and 12 weeks]
Score at week 4,8 and 12 point after medication
- Sheehan Disability Scale(SDS) score [at 12 weeks]
change from baseline in SDS score at week 12
- 5-item World Health Organization Well-Being Index(WHO-5) [at 12 weeks]
change from baseline in WHO-5 score at week 12
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who have voluntarily signed the instruction and consent form for the use of personal information
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Adults over 19 years of age
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Patients diagnosed with Depressive disorders according to the DSM-5 criteria
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Patients with a HAM-A score of 18 or higher on the date of enrollment
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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)
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Patients with the ability to read and understand self-rated scales
Exclusion Criteria:
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Patients listed in the contraindication group for Buspar® Tab (Buspirone)
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Patients administered an azapirone class of anxiolytics including buspirone during the last 4 weeks
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Patients administered a benzodiazepine class of anxiolytics for the first time or with a dose change during the last 1 weeks
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Patients administered a psychostimulant or medication for attention deficit hyperactivity disorder (ADHD) during the last 4 weeks
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Pregnant or lactating women
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Subjects participating in another clinical trial or taking an investigational product for another clinical trial within 12 weeks after the screening visit (Visit 1)
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Patients determined by the Investigator to be at risk of suicide, self-harm, or hurting others
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Other subjects determined to be unsuitable by the Investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | Yeouido | Korea, Republic of | 03127 |
Sponsors and Collaborators
- Boryung Pharmaceutical Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BR-BPR-OS-401