Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder

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

Achieving results from RCTs with high internal and external validity is a major challenge within psychiatry due to the nature of psychiatric illnesses. The Investigators 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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Antidepressant

• Study Type: Observational
• Enrollment (Actual): 73336

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Psychiatric Center Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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).

Exclusion Criteria:

None.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response	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 .	2 years

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; 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; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Hypnotics and Sedatives; 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; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic Uptake Inhibitors; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Selective Serotonin Reuptake Inhibitors; Sertraline; Duloxetine Hydrochloride; Citalopram; Paroxetine; Vortioxetine; Amitriptyline; Venlafaxine Hydrochloride; Mirtazapine; Fluoxetine; Antidepressive Agents; Reboxetine; Imipramine; Escitalopram; Agomelatine
• Other Study ID Numbers: MHSCRDenmark_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No