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Completed

NCT Number: NCT04770454

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

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

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Key information

Conditions

Depressive Disorder, Major Anxiety Disorders Depressive Disorder Mental Disorders Mood Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Seoul, Yeouido, 03127, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have voluntarily signed the instruction and consent form for the use of personal information
  • Adults over 19 years of age
  • Patients diagnosed with Depressive disorders according to the DSM-5 criteria
  • Patients with a HAM-A score of 18 or higher on the date of enrollment
  • 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)
  • 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 1 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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

    *The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  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

    *The Hamilton Depression Rating Scale (HAM-D) contains 17 items (HDRS17) pertaining to symptoms of depression experienced over the past week. For the HDRS17, a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

  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

    *The CGI-Severity (CGI-S) asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.

  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

    *The CGI-Improvement (CGI-I) is similarly simple. Each time the patient is seen after medication has been initiated, the clinician compares the patient's overall clinical condition to the one week period just prior to the initiation of medication use (the so-called baseline visit). Only the following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment."

  5. Sheehan Disability Scale(SDS) score

    Time frame: at 12 weeks

    change from baseline in SDS score at week 12

    *Sheehan Disability Scale(SDS) generates 4 scores: a work disability score, a social life disability score, a family life disability score and a total score. To get a total score add up the 3 individual scores (work: social life: family life). The maximum possible score is 30.

  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

    *WHO-5 Well-being Index (WHO-5) consists of five positively worded items that are rated on 6-point Likert scale, ranging from 0 (representing worst possible) to 5 (representing best possible quality of life).

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Acronym: BASIS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2021
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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