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

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Drug: Escitalopram; Drug: Paroxetine; Drug: Fluoxetine; Drug: Mirtazapine; Drug: Duloxetine; Drug: Sertraline; Drug: Venlafaxine; Drug: Tianeptine; Drug: Vortioxetine; Drug: Desvenlafaxine; Drug: Bupropion

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 405349

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects who newly initiated antidepressant therapies between Jan 01, 2017 to Jun 30, 2018 in the National Health Insurance Service (NHIS) database

Description

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*)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

11

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1. Escitalopram Cohort	Drug: Escitalopram; Treatment for depression
2. Paroxetine Cohort	Drug: Paroxetine; Treatment for depression
3. Fluoxetine Cohort	Drug: Fluoxetine; Treatment for depression
4. Mirtazapine Cohort	Drug: Mirtazapine; Treatment for depression
5. Duloxetine Cohort	Drug: Duloxetine; Treatment for depression
6. Sertraline Cohort	Drug: Sertraline; Treatment for depression
7. Venlafaxine Cohort	Drug: Venlafaxine; Treatment for depression
8. Tianeptine Cohort	Drug: Tianeptine; Treatment for depression
9. Vortioxetine Cohort	Drug: Vortioxetine; Treatment for depression
10. Desvenlafaxine Cohort	Drug: Desvenlafaxine; Treatment for depression
11. Bupropion Cohort	Drug: Bupropion; Treatment for depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Dosage: Index date	Initial dosages at the index date	90 days
Dosage: Acute treatment phase	Average dosages during the first 90 days of treatment (acute treatment phase)	90 days
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
Discontinuation	Percentage of patients discontinued each index drug within first 90 days of index treatment	90 days
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
Recurrence	Percentage of patients experiencing recurrence (as measured by inpatient episode, emergency room visit, or suicide attempt) within 6 months of treatment	6 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug utilization pattern in acute phase	Percentage of patients on monotherapy, combination therapy, augmentation therapy during 90 days of treatment	90 days
Drug utilization pattern in maintenance phase	Precentage of patients on monotherapy, combination therapy, augmentation therapy during 90-180 days of treatment	90 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): November 3, 2022

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Antidepressive Agents, Tricyclic; Cytochrome P-450 CYP2D6 Inhibitors; Serotonin 5-HT3 Receptor Antagonists; Dopamine Uptake Inhibitors; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Sertraline; Duloxetine Hydrochloride; Citalopram; Paroxetine; Vortioxetine; Bupropion; Desvenlafaxine Succinate; Venlafaxine Hydrochloride; Mirtazapine; Fluoxetine; Tianeptine
• Other Study ID Numbers: B2061147; CAR-BIG Study (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes