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 in Korea
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 in Korea
Approximately 20 sites in Korea including the Catholic University of Korea, Yeouido St.
 Mary's Hospital.

 Patients with major depressive disorder (MDD) taking a selective serotonin reuptake inhibitor
 (SSRI) antidepressant, 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
Inclusion Criteria 1) Patients who have voluntarily signed the instruction and consent form
 for the use of personal information 2) Adults over 19 years of age 3) Patients diagnosed with
 depression according to the DSM-5 criteria 4) Patients with a HAM-A score of 18 or higher on
 the date of enrollment 5) Patients taking an SSRI antidepressant at an effective dose or
 higher for 4 weeks or longer whose symptoms of anxiety are being additionally treated with
 Buspar® Tab (Buspirone) 6) Patients with the ability to read and understand self-rated scales
 Exclusion Criteria

 1. Patients listed in the contraindication group for Buspar® Tab (Buspirone)

 2. Patients administered an azapirone class of anxiolytics including buspirone during the
 last 4 weeks

 3. Patients administered a benzodiazepine class of anxiolytics for the first time or with a
 dose change during the last 4 weeks

 4. Patients administered a psychostimulant or medication for attention deficit
 hyperactivity disorder (ADHD) during the last 4 weeks

 5. Pregnant or lactating women

 6. Subjects participating in another clinical trial or taking an investigational product
 for another clinical trial within 12 weeks after the screening visit (Visit 1)

 7. Patients determined by the Investigator to be at risk of suicide, self-harm, or hurting
 others

 8. Other subjects determined to be unsuitable by the Investigator Study Methodology In this
 study, necessary data will be collected by history taking and medical record review of
 patients who are taking an SSRI 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.

 <Follow-up observation period and data collected> As this study is non-interventional and
 performed as a part of clinical practice, the number of visits, intervals, and prescriptions
 are determined by the investigator's judgment. The follow-up observation period mentioned
 below means the data collection period. Aside from the follow-up observation period stated in
 this protocol, the visit schedule is flexible and may be determined by the investigator based
 on the medical condition of the patient. Also, data obtained during the study period may be
 collected in the CRF if they are considered to be necessary for this study.

 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.

 1. Each subject is observed for 12 weeks and the data are collected at four time points:
 Visit 1 (baseline), Visit 2 (week 4±2W), Visit 3 (week 8±2W), and Visit 4 (week 12±4W)

 2. Demographic information: Sex, age (date of birth), and education level

 3. Medical history and concurrent disease related to psychiatric disorders: Age (year) of
 onset of major depressive disorder, number of past major depressive episodes, duration
 (months) of the current major depressive episode, number of past suicide attempts, if
 any, family history related to psychiatric disorders, family history related to
 depressive disorders, and current psychiatric diagnosis other than major depressive
 disorders, if any

 4. Concurrent disease other than psychiatric disorder: Diagnosis and onset of concurrent
 disease other than psychiatric disorder, if any

 5. Record of administration of psychiatric drug(s) before enrollment and during the study
 period: Name of drug (ingredient name), purpose, dose, number of daily administrations,
 route of administration, and duration of administration of psychiatric drug(s)
 administered within 12 weeks before the date of enrollment or during the study period.

 6. Record of administration of antidepressant(s) and buspirone before enrollment or during
 the study period: Name of drug (ingredient name), purpose, dose, number of daily
 administrations, route of administration, and duration of administration (start date and
 end date) of antidepressant(s) and buspirone administered within 4 weeks before the date
 of enrollment or during the study period

 7. Height and weight: Record the height (cm) and weight (kg).

 8. Physical examination: Check for abnormalities of organs by means of inspection, history
 taking, auscultation, percussion, and palpation. Record abnormalities identified through
 examination on the corresponding page of the CRF.

 9. Confirmation of inclusion/exclusion criteria

 10. Clinical assessment scale

 -  Hamilton Anxiety Rating Scale (HAM-A): Baseline, Week 4, Week 8, and Week 12

 -  Hamilton Depression Rating Scale (HAM-D): Baseline, Week 4, Week 8, and Week 12

 -  Clinical Global Impression Scale-Severity (CGI-S): Baseline, Week 4, Week 8, and
 Week 12

 -  Clinical Global Impression Scale-Improvement (CGI-I): Week 4, Week 8, and Week 12

 -  Sheehan Disability Scale (SDS): Baseline and Week 12

 -  Five-item World Health Organization Well-Being Index (WHO-5): Baseline and Week 12

 11. Adverse event information: Information regarding all adverse drug reactions (ADRs),
 serious adverse events (SAEs), and serious adverse drug reactions (SADRs) occurring
 after the administration of Buspar® Tab (Buspirone)

 12. Concomitant medication: Name of drug (ingredient name), purpose, dose, number of daily
 administrations, route of administration, and duration of administration of the
 concomitant medication (s) Efficacy Endpoints

 Efficacy Endpoints

 1. Primary endpoint The HAM-A score change at 12 weeks from the baseline

 2. Secondary endpoints 1) The HAM-A score changes at 4 and 8 weeks from the baseline 2) The
 HAM-D score changes at 4, 8, and 12 weeks from the baseline 3) The CGI-S score changes
 at 4, 8, and 12 weeks from the baseline 4) The CGI-I scores at 4, 8, and 12 weeks after
 the administration 5) The SDS score change at 12 weeks from the baseline 6) The WHO-5
 score change at 12 weeks from the baseline

 3. Subgroup analysis of the primary and secondary endpoints 1) Buspar® Tab (Buspirone) dose
 2) Concomitant administration of a benzodiazepine class drug 3) Reduction of the dose of
 benzodiazepine class drug with reasons after the administration of Buspar® Tab
 (Buspirone) 4) Dose of benzodiazepine class drug after the administration of Buspar® Tab
 (Buspirone)
Inclusion Criteria:

 1. Patients who have voluntarily signed the instruction and consent form for the use of
 personal information

 2. Adults over 19 years of age

 3. Patients diagnosed with depression according to the DSM-5 criteria

 4. Patients with a HAM-A score of 18 or higher on the date of enrollment

 5. Patients taking an SSRI antidepressant at an effective dose or higher for 4 weeks or
 longer whose symptoms of anxiety are being additionally treated with Buspar® Tab
 (Buspirone)

 6. Patients with the ability to read and understand self-rated scales

 Exclusion Criteria:

 1. Patients listed in the contraindication group for Buspar® Tab (Buspirone)

 2. Patients administered an azapirone class of anxiolytics including buspirone during the
 last 4 weeks

 3. Patients administered a benzodiazepine class of anxiolytics for the first time or with
 a dose change during the last 4 weeks

 4. Patients administered a psychostimulant or medication for attention deficit
 hyperactivity disorder (ADHD) during the last 4 weeks

 5. Pregnant or lactating women

 6. Subjects participating in another clinical trial or taking an investigational product
 for another clinical trial within 12 weeks after the screening visit (Visit 1)

 7. Patients determined by the Investigator to be at risk of suicide, self-harm, or
 hurting others

 8. Other subjects determined to be unsuitable by the Investigator