Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder

Sponsor

Mental Health Services in the Capital Region, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT05952713

Collaborator

University of Copenhagen (Other)

73,336

Enrollment

Location

Actual Duration (Months)

8176.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Achieving results from RCTs with high internal and external validity is a major challenge within psychiatry due to the nature of psychiatric illnesses. We will conduct a "real world" naturalistic nation-wide population-based longitudinal register linkage study comparing long-term responses to all kinds of antidepressants in patients with major depressive disorder emulating a randomized trial.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Antidepressant

Study Design

Study Type:

Observational

Actual Enrollment :

73336 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder - Results From a Long-term Nation-wide Population-based Study Emulating a Randomized Trial

Actual Study Start Date :

Oct 1, 2022

Actual Primary Completion Date :

Jul 1, 2023

Actual Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
SSRI Group 1: Selective serotonin reuptake inhibitors (reference: sertraline) Comparisons of the following with sertraline: Citalopram, Fluoxetine, Paroxetine, Escitalopram	Drug: Antidepressant Treatment with an antidepressant according to Danish register data. Other Names: sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine
NARI Group 2: Noradrenaline reuptake inhibitors (reference: sertraline) Comparisons of the following with sertraline: Reboxetine	Drug: Antidepressant Treatment with an antidepressant according to Danish register data. Other Names: sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine
SNRI Group 3: Serotonin and noradrenaline reuptake inhibitors (reference: venlafaxine) Comparisons of Duloxetine with venlafaxine	Drug: Antidepressant Treatment with an antidepressant according to Danish register data. Other Names: sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine
ARI Group 4: Adrenergic receptor inhibitors (reference: Mirtazapine) Comparisons of Mianserin with Mirtazapine	Drug: Antidepressant Treatment with an antidepressant according to Danish register data. Other Names: sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine
Other drugs Group 5: Other drugs (reference: sertraline) Comparisons of Vortioxetine and Agomelatine with sertraline	Drug: Antidepressant Treatment with an antidepressant according to Danish register data. Other Names: sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine
TCA Group 6: Tricyclic antidepressants (reference: amitriptyline) Comparisons of Nortriptyline, Imipramine, Clomipramine and Dosulepin with amitriptyline	Drug: Antidepressant Treatment with an antidepressant according to Danish register data. Other Names: sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine

Outcome Measures

Primary Outcome Measures

Response [2 years]
Response was defined as continuous monotherapy with an antidepressant drug without switch to or add-on of another antidepressant drug, an antipsychotic drug or lithium or hospitalization with a main ICD-10 diagnosis of a single depressive episode or recurrent depressive disorder .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients with a psychiatric contact (as inpatients or outpatients) in the period from 1995 to 2018 with a first main index diagnosis of a single depressive episode or recurrent depressive disorder (ICD-10 code: F32-F33.9) with an outpatient purchase of an antidepressant after the depression diagnosis (N=73.336).