Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder

NCT05952713 | Completed

• 1 other identifier: MHSCRDenmark_2
• Study Type: observational
• Target: 73,336
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

SSRI

Group 1: Selective serotonin reuptake inhibitors (reference: sertraline) Comparisons of the following with sertraline: Citalopram, Fluoxetine, Paroxetine, Escitalopram

Drug: Antidepressant

NARI

Group 2: Noradrenaline reuptake inhibitors (reference: sertraline) Comparisons of the following with sertraline: Reboxetine

Drug: Antidepressant

SNRI

Group 3: Serotonin and noradrenaline reuptake inhibitors (reference: venlafaxine) Comparisons of Duloxetine with venlafaxine

Drug: Antidepressant

ARI

Group 4: Adrenergic receptor inhibitors (reference: Mirtazapine) Comparisons of Mianserin with Mirtazapine

Drug: Antidepressant

Other drugs

Group 5: Other drugs (reference: sertraline) Comparisons of Vortioxetine and Agomelatine with sertraline

Drug: Antidepressant

TCA

Group 6: Tricyclic antidepressants (reference: amitriptyline) Comparisons of Nortriptyline, Imipramine, Clomipramine and Dosulepin with amitriptyline

Drug: Antidepressant

Interventions

Antidepressant DRUG

Treatment with an antidepressant according to Danish register data.

Also known as: sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine

ARI; NARI; Other drugs; SNRI; SSRI; TCA

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• None.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Psychiatric Center Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Antidepressive Agents; Sertraline; Citalopram; Fluoxetine; Paroxetine; Escitalopram; Reboxetine; Venlafaxine Hydrochloride; Duloxetine Hydrochloride; Mirtazapine; Vortioxetine; agomelatine; Amitriptyline; Imipramine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Morpholines; Oxazines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids; Thiophenes; Sulfur Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Piperazines; Dibenzocycloheptenes; Benzocycloheptenes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: October 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)