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

Summary

Participation Requirements

Description

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 enrollmen...

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 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 4 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 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. 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) Demographic information: Sex, age (date of birth), and education level 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 Concurrent disease other than psychiatric disorder: Diagnosis and onset of concurrent disease other than psychiatric disorder, if any 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. 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 Height and weight: Record the height (cm) and weight (kg). 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. Confirmation of inclusion/exclusion criteria 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 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) 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 Primary endpoint The HAM-A score change at 12 weeks from the baseline 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 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)

Tracking Information