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Depressive Disorder, MajorBASISNCT04770454

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

An observational study of Depressive Disorder, Major and Anxiety Disorders, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Depressive Disorder, Major, Anxiety Disorders
How many people
200 participants
Where
1 siteSouth Korea
Study dates
8 Feb 2021to 30 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

    Seoul, Yeouido, 03127

Other trials in South Korea

About this study

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

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

Read the 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.

Medical subject headings
Depressive Disorder, Major, Anxiety Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Anxiety Rating Scale (HAM-A) score

    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.

    Measured: at 12 weeks

Secondary outcomes (6)

  1. Hamilton Anxiety Rating Scale (HAM-A) score

    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.

    Measured: at 4 and 8 weeks

  2. Hamilton Depression Rating Scale (HAM-D) score

    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.

    Measured: at 4, 8, and 12 weeks

  3. Clinical Global Impression Scale-Severity(CGI-S)

    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.

    Measured: at 4, 8, and 12 weeks

  4. Clinical Global Impression Scale-Improvement(CGI-I)

    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."

    Measured: at 4, 8, and 12 weeks

  5. Sheehan Disability Scale(SDS) score

    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.

    Measured: at 12 weeks

  6. 5-item World Health Organization Well-Being Index(WHO-5)

    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).

    Measured: at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2021
  2. Study start8 Feb 2021
  3. Primary completion30 Mar 2023
  4. Study completion30 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04770454
Sponsor's protocol ID
BR-BPR-OS-401
Acronym
BASIS
Status last verified
Jun 2023
First submitted
22 Feb 2021
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Depressive Disorder, Major and Anxiety Disorders, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Anxiety Rating Scale (HAM-A) score (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04770454.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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