Clinical trial NCT04770454: Evaluate the Quality of Life and Treatment of Anxiety Symptoms of Buspirone in Patients With Depression Disorders(BASIS)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Anxiety Disorders
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Hamilton Anxiety Rating Scale (HAM-A) score
timeFrame: at 12 weeks
Secondary outcomes:
measure: Hamilton Anxiety Rating Scale (HAM-A) score
timeFrame: at 4 and 8 weeks
measure: Hamilton Depression Rating Scale (HAM-D) score
timeFrame: at 4, 8, and 12 weeks
measure: Clinical Global Impression Scale-Severity(CGI-S)
timeFrame: at 4, 8, and 12 weeks
measure: Clinical Global Impression Scale-Improvement(CGI-I)
timeFrame: at 4, 8, and 12 weeks
measure: Sheehan Disability Scale(SDS) score
timeFrame: at 12 weeks
measure: 5-item World Health Organization Well-Being Index(WHO-5)
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: the Catholic University of Korea, Yeouido St. Mary's Hospital
state: Yeouido
Study officials:
affiliation: Boryung Pharmaceutical Co., Ltd
name: Myung-Sook Hong
role: STUDY_DIRECTOR
References: