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) (BASIS)

• ClinicalTrials.gov Identifier: NCT04770454
• Recruitment Status: Recruiting
• First Posted: February 25, 2021
• Last Update Posted: October 26, 2021
• Sponsor: Boryung Pharmaceutical Co., Ltd
• Information provided by (Responsible Party): Boryung Pharmaceutical Co., Ltd

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
Depressive Disorder, Major; Anxiety Disorders	Drug: Buspiron

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

• Study Type: Observational
• Estimated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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 Disorder in Korea
• Actual Study Start Date: February 8, 2021
• Estimated Primary Completion Date: June 1, 2022
• Estimated Study Completion Date: July 1, 2022

Groups and Cohorts

Intervention Details:

• Drug: Buspiron
  As this study is a non-interventional observational study, treatments are determined by the investigator in consideration of the medical condition of the subject in normal clinical practice. Therefore, information regarding dosage and administration of the drug is not provided in the study protocol; rather, the investigator determines the appropriate dose by considering the approved dose of the drug and the medical condition of the subject.

Outcome Measures

Primary Outcome Measures :

1. Hamilton Anxiety Rating Scale (HAM-A) score [ Time Frame: 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 :

1. Hamilton Anxiety Rating Scale (HAM-A) score [ Time Frame: at 4 and 8 weeks ]
   change from baseline in HAM-A score at week 4,8
2. Hamilton Depression Rating Scale (HAM-D) score [ Time Frame: at 4, 8, and 12 weeks ]
   change from baseline in HAM-D score at week 4,8 and 12
3. Clinical Global Impression Scale-Severity(CGI-S) [ Time Frame: at 4, 8, and 12 weeks ]
   change from baseline in CGI-S score at week 4,8 and 12
4. Clinical Global Impression Scale-Improvement(CGI-I) [ Time Frame: at 4, 8, and 12 weeks ]
   Score at week 4,8 and 12 point after medication
5. Sheehan Disability Scale(SDS) score [ Time Frame: at 12 weeks ]
   change from baseline in SDS score at week 12
6. 5-item World Health Organization Well-Being Index(WHO-5) [ Time Frame: at 12 weeks ]
   change from baseline in WHO-5 score at week 12

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Patients with Depressive disorders taking a selective serotonin reuptake inhibitor (SSRI) antidepressant or Serotonin and norepinephrine reutake inhibitor(SNRI)antidepressant, who additionally administered Buspar® Tab (Buspirone) to control symptom of anxiety.

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

Contacts and Locations

Contacts

Contact: HyoJae Kim; 82-2-2094- ext 8203; igniter@boryung.co.kr

Locations

Korea, Republic of

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

Seoul, Yeouido, Korea, Republic of, 03127

Contact: WonMyung Park, Dr

Sponsors and Collaborators

Boryung Pharmaceutical Co., Ltd

More Information

• Responsible Party: Boryung Pharmaceutical Co., Ltd
• ClinicalTrials.gov Identifier: NCT04770454
• Other Study ID Numbers: BR-BPR-OS-401
• First Posted: February 25, 2021
• Last Update Posted: October 26, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Disease; Anxiety Disorders; Depressive Disorder; Depressive Disorder, Major; Pathologic Processes; Mental Disorders; Mood Disorders; Buspirone; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action