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

NCT ID: NCT04770454

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2023-03-30

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

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.

Conditions

Depressive Disorder, Major; Anxiety Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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 Depressive disorders 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 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)

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 1 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myung-Sook Hong

Role: STUDY_DIRECTOR

Boryung Pharmaceutical Co., Ltd

Locations

the Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, Yeouido, South Korea

Countries

South Korea

Other Identifiers

BR-BPR-OS-401

Identifier Type: -

Identifier Source: org_study_id