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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05952713
Other study ID # MHSCRDenmark_2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date July 1, 2023

Study information

Verified date July 2023
Source Mental Health Services in the Capital Region, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 73336
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Intervention

Drug:
Antidepressant
Treatment with an antidepressant according to Danish register data.

Locations

Country Name City State
Denmark Psychiatric Center Copenhagen Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Mental Health Services in the Capital Region, Denmark University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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