Status:
COMPLETED
Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benef...
Detailed Description
The study will consist of a screening period of up to 14 days before the Baseline Visit, followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety Follow-up Visit will be pe...
Eligibility Criteria
Inclusion
- The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current MDE must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has a MADRS total score ≥24 at screening and baseline.
- The patient has had the current MDE for ≥3 months and \< 12 months.
- The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE with a partial response and is a candidate for a switch in the investigator's opinion.
- The patient wants to switch antidepressant treatment.
Exclusion
- The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
- Other in- and exclusion criteria may apply
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2022
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT04448431
Start Date
June 18 2020
End Date
February 4 2022
Last Update
February 14 2022
Active Locations (80)
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1
Clinica Privada Banfield
Banfield, Buenos Aires, Argentina, B1828CKR
2
Cenydet-Centro Neurobiologico Y De Estres Traumatico-Biopsychomedical Research Group Srl
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1058AAJ
3
Fundacion para el Estudio y Tratamiento de las enfermedades mentales FETEM
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1133AAH
4
INAPsi (Instituto Nacional de Psicopatologia)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BOA