Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea

Major Depression Clinical Trial

Official title:

Comparison of Antidepressants in the Real-World: Retrospective Cohort Study Using Big Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446039
• Other study ID #: B2061147
• Secondary ID: CAR-BIG Study
• Status: Completed
• Start date: July 4, 2022
• Est. completion date: November 3, 2022

Study information

• Verified date: November 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary purpose of this study is to investigate medication utilization pattern and risk of adverse outcomes among commonly used antidepressants by using nationwide claims database, in order to assess overall clinical benefit of antidepressant therapy in real-world practice.

Description:

While there are many antidepressants from which physicians can select based on efficacy and tolerability profile, evidence on effectiveness and safety outcomes of new antidepressants in real clinical practice among Korean MDD population is limited.

Hence, this study will explore the following primary, secondary objectives using national health insurance database :

1. Explore baseline characteristics and drug utilization patterns of 11 commonly used antidepressant therapy during 90 days of acute treatment phase

2. Explore drug utilization patterns such as therapy changes, medication compliance and recurrence relationship, and risk of adverse outcomes during maintenance phase

3. Choice of antidepressants and drug utilization patterns in patients with various comorbidities

4. The relationship of non-pharmacologic treatment and discontinuation, medication compliance

5. Choice of antidepressants by non-psychiatric specialty

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405349
• Est. completion date: November 3, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Patients aged 18 years or older on the index date

2. Patients who had at least one inpatient claim or two outpatient claims in the intake period with any of the following diagnosis codes F06.3 Organic mood [affective] disorders F32* Depressive episode F33* Recurrent depressive disorder F34.1 Neurotic depression F38.1 Other recurrent mood [affective] disorder F41.2 Mixed anxiety and depressive disorder

3. Patients prescribed any of the following antidepressant during intake period (from January 1, 2017 to June 30, 2018)

Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study:

1. Patients with a claim of diagnosis codes in Table 1 during the 12 month pre-index period

2. Patients with a claim of prescription in Table 2 during the 12 month pre-index period

3. Patient who had a claim as a beneficiary of Medical Aid program (Korean Medicaid program with free or minimum copay)

4. Patients who are hospitalized at the index date

5. Patients who are under hospice care (procedure codes WG*-WO*)

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Escitalopram
Treatment for depression
• Paroxetine
Treatment for depression
• Fluoxetine
Treatment for depression
• Mirtazapine
Treatment for depression
• Duloxetine
Treatment for depression
• Sertraline
Treatment for depression
• Venlafaxine
Treatment for depression
• Tianeptine
Treatment for depression
• Vortioxetine
Treatment for depression
• Desvenlafaxine
Treatment for depression
• Bupropion
Treatment for depression

Locations

Country	Name	City	State
Korea, Republic of	Pfizer	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of antidepressants	Proportion out of total prescriptions in the first 90 days from the index date (acute treatment phase) by gender, age groups (20, 21-64, 65)	90 days
Primary	Dosage: Index date	Initial dosages at the index date	90 days
Primary	Dosage: Acute treatment phase	Average dosages during the first 90 days of treatment (acute treatment phase)	90 days
Primary	Persistence: Average length of treatment	Average length of treatment of each index drugs (allowing 14 day permissible gap) will be calculated.; -Switching, combination, augmentation, discontinuation will terminate the persistent period	6 months
Primary	Discontinuation	Percentage of patients discontinued each index drug within first 90 days of index treatment	90 days
Primary	Adherence	For each index drug, adherence will be measured as percentage of drug possessed (measured by medication possession ratio) within 90 days of index treatment	90 days
Primary	Recurrence	Percentage of patients experiencing recurrence (as measured by inpatient episode, emergency room visit, or suicide attempt) within 6 months of treatment	6 months
Primary	Adverse outcomes	Percentage of adverse events (as measured by GI bleeding, fractures, falls, intracranial hemorrhage, suicide attempt, self-harm, myocardial infarction, epilepsy/seizures, stroke, hyponatremia) within 6 months of treatment	6 months
Secondary	Drug utilization pattern in acute phase	Percentage of patients on monotherapy, combination therapy, augmentation therapy during 90 days of treatment	90 days
Secondary	Drug utilization pattern in maintenance phase	Precentage of patients on monotherapy, combination therapy, augmentation therapy during 90-180 days of treatment	90 days

External Links

•   To obtain contact information for a study center near you, click here.