Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression

NCT ID: NCT04448431

Last Updated: 2022-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

605 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-18

Study Completion Date

2022-02-04

Brief Summary

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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 benefit

Detailed Description

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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 performed approximately 4 weeks after the Primary Outcome/Withdrawal Visit.

At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an 8-week, double-blind Treatment Period.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vortioxetine

8 weeks treatment

Group Type EXPERIMENTAL

Vortioxetine

Intervention Type DRUG

10 or 20 mg/day, capsules, orally

Desvenlafaxine

8 weeks treatment

Group Type ACTIVE_COMPARATOR

Desvenlafaxine

Intervention Type DRUG

50 mg/day capsules, orally

Interventions

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Vortioxetine

10 or 20 mg/day, capsules, orally

Intervention Type DRUG

Desvenlafaxine

50 mg/day capsules, orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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Clinica Privada Banfield

Banfield, Buenos Aires, Argentina

Site Status

Cenydet-Centro Neurobiologico Y De Estres Traumatico-Biopsychomedical Research Group Srl

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Fundacion para el Estudio y Tratamiento de las enfermedades mentales FETEM

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

INAPsi (Instituto Nacional de Psicopatologia)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Clinica Privada De Salud Mental Santa Teresa De Avila

La Plata, Buenos Aires, Argentina

Site Status

Instituto De Neurociencias San Agustin SA

La Plata, Buenos Aires, Argentina

Site Status

Sanatorio Prof. Leon S. Morra S.A.

Córdoba, Providencia de Cordo, Argentina

Site Status

CIAP (Centro de Investigacion y Asistencia en Psiquiatria)

Rosario, Santa Fe Province, Argentina

Site Status

CINME (Centro de Investigaciones Metabolicas de Buenos Aires)

Buenos Aires, , Argentina

Site Status

CEN (Centro Especializado Neurociencias)

Córdoba, , Argentina

Site Status

Instituto Modelo de Neurologia Fundacion Lennox

Córdoba, , Argentina

Site Status

Instituto Medico DAMIC - Fundacion Rusculleda

Córdoba, , Argentina

Site Status

Centro De Asistencia E Investigacion En Neurociencias CENAIN

Mendoza, , Argentina

Site Status

Resolution Psicopharmacology Research Institute

Mendoza, , Argentina

Site Status

Algemeen Ziekenhuis St. Lucas-St. Jozef

Bruges, , Belgium

Site Status

SINAPS - University Antwerpe- Psychiatrisch Ziekenhuis Duffel

Duffel, , Belgium

Site Status

Cliniques De Mont-Godinne

Yvoir, , Belgium

Site Status

MHAT Dr. Hristo Stambolski

Kazanlak, , Bulgaria

Site Status

UMHAT Sv. Ivan Rilski EAD

Plovdiv, , Bulgaria

Site Status

Center For Mental Health-Rousse

Rousse, , Bulgaria

Site Status

MC Complete Medical Solutions

Samokov, , Bulgaria

Site Status

Centre for Mental Health- Sofia

Sofia, , Bulgaria

Site Status

Diagnostic Consultative Center Mladost-M Varna OOD

Varna, , Bulgaria

Site Status

Clintrial s.r.o.

Prague, Prague 10, Czechia

Site Status

Dr.Jan Holan MD, Office of

Brno, , Czechia

Site Status

Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum

Havířov, , Czechia

Site Status

Clinline services s.r.o.

Hostivice, , Czechia

Site Status

Neuropsychiatrie HK, s.r.o.

Hradec Králové, , Czechia

Site Status

National Institute of Mental Health

Klecany, , Czechia

Site Status

Psychiatricka Ambulance

Kutná Hora, , Czechia

Site Status

A-Shine s.r.o.

Pilsen, , Czechia

Site Status

Institut neuropsychiatricke pece

Prague, , Czechia

Site Status

Marienthali Kliinik

Tallinn, , Estonia

Site Status

Psihiatrijas Centrs

Liepāja, Liepajas Rajons, Latvia

Site Status

Riga Centre Of Psychiatry And Addiction Disorders

Riga, , Latvia

Site Status

Sigulda Hospital Outpatient Clinic

Sigulda, , Latvia

Site Status

CRI Centro Regiomontano de Investigacion SC

Monterrey, Nuevo León, Mexico

Site Status

Medical Care and Research S.A. de C.V.

Mérida, Yucatán, Mexico

Site Status

Health Pharma Professional Research S.A. de C.V.

Mexico City, , Mexico

Site Status

Region Specialized Psychiatric Hospital No.2

Stavropol Region, Kochubeev District, Russia

Site Status

Leningrad Regional Psychoneurological Dispensary

Roshchino, Leningradskaya Oblast', Russia

Site Status

Arkhangelsk Regional Clinical Mental Hospital

Arkhangelsk, , Russia

Site Status

GUZ Engels Psychiatric Hospital

Engel's, , Russia

Site Status

Moscow Scientific Research Institute of Psychiatry

Moscow, , Russia

Site Status

Clinic named after professor Yu. N. Kasatkin FGBOU DPO RMANPO Minzdrava Rossii

Moscow, , Russia

Site Status

Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...

Nizhny Novgorod, , Russia

Site Status

Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

Rostov-on-Don, , Russia

Site Status

LLC Medical Center Nova Vita

Rostov-on-Don, , Russia

Site Status

St. Nicolas State Psychiatric Hospital

Saint Petersburg, , Russia

Site Status

Hospital OrKli , LLC

Saint Petersburg, , Russia

Site Status

LLC Astarta

Saint Petersburg, , Russia

Site Status

Saratov State Medical University

Saratov, , Russia

Site Status

State Budgetery Educational Institution Of Higher Professional Education Smolensk State Medical U...

Smolensk, , Russia

Site Status

Yaroslavl Regional Clinical Psychiatry Hospital

Yaroslavl, , Russia

Site Status

Psychiatricka ambulancia, MENTUM, s.r.o.

Bratislava, , Slovakia

Site Status

Epamed, S.R.O

Košice, , Slovakia

Site Status

Psycholine S.R.O.

Rimavská Sobota, , Slovakia

Site Status

Crystal Comfort, s.r.o.

Vranov Nad Topou, , Slovakia

Site Status

BONA MEDIC s.r.o.

Zlaté Moravce, , Slovakia

Site Status

Psychiatricka Ambulancia

Zlaté Moravce, , Slovakia

Site Status

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, Spain

Site Status

Centro De Salud Mental La Corredoria

Oviedo, Principality of Asturias, Spain

Site Status

Hospital De La Santa Creu I Sant Pau

Barcelona, , Spain

Site Status

Hospital Psiquiatric de Palma de Mallorca

Palma de Mallorca, , Spain

Site Status

Smaert & Psykiatricentrum Malmoe

Malmo, Skåne County, Sweden

Site Status

Affecta Psyikiatri AB

Halmstad, , Sweden

Site Status

ProbarE i Lund

Lund, , Sweden

Site Status

ONE LIFETIME Lakarmottagning

Skövde, , Sweden

Site Status

ProbarE

Stockholm, , Sweden

Site Status

Communal Non-commercial Enterprise Cherkasy regional psychiatric hospital of Cherkasy regional co...

Smila, Cherkasy Oblast, Ukraine

Site Status

Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional clinical psychiatric hosp...

Kharkiv, Kharkivska, Ukraine

Site Status

Municipal Non-profit Enterprise Odesa Regional Psychiatric Hospital No.2 of Odesa Regional Council

Kominternivskyy, Odesa Oblast, Ukraine

Site Status

CI of KRC Regional psychiatric and narcological medical association

Hlevakha, , Ukraine

Site Status

Ivano-Frankivsk Oblast neuropsychiatric hospital No. 3

Ivano-Frankivsk, , Ukraine

Site Status

Academy of Medical Sciences of Ukraine - Institute of Neurology, Psychiatry and Narcology

Kharkiv, , Ukraine

Site Status

SI INPN Namsu

Kharkiv, , Ukraine

Site Status

Lviv Regional State Clinical Psychiatric Hospital, Lviv Danylo Galytsky National Medical University

Lviv, , Ukraine

Site Status

Odessa Regional Medical Centre of Mental Health

Odesa, , Ukraine

Site Status

Ukrainian Medical Stomatological Academy, Chair Of Psychiatry, Narcology And Medical Psychology B...

Poltava, , Ukraine

Site Status

Vinnitsa National Medical University

Vinnitsa, , Ukraine

Site Status

Countries

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Argentina Belgium Bulgaria Czechia Estonia Latvia Mexico Russia Slovakia Spain Sweden Ukraine

References

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Gill H, McIntyre RS, Christensen MC. Analysis of reward behavior in patients with MDD and partial response to SSRI therapy treated with vortioxetine versus desvenlafaxine: Experience with the Effort-Expenditure for Rewards Task (EEfRT) in the VIVRE study. J Affect Disord. 2025 Nov 1;388:119563. doi: 10.1016/j.jad.2025.119563. Epub 2025 May 31.

Reference Type DERIVED
PMID: 40456468 (View on PubMed)

McIntyre RS, Florea I, Pedersen MM, Christensen MC. Head-To-Head Comparison of Vortioxetine Versus Desvenlafaxine in Patients With Major Depressive Disorder With Partial Response to SSRI Therapy: Results of the VIVRE Study. J Clin Psychiatry. 2023 May 22;84(4):23m14780. doi: 10.4088/JCP.23m14780.

Reference Type DERIVED
PMID: 37227402 (View on PubMed)

Other Identifiers

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18498A

Identifier Type: -

Identifier Source: org_study_id

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