NCT04448431

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 benefit

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
605

participants targeted

Target at P75+ for phase_4 major-depressive-disorder

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_4 major-depressive-disorder

Geographic Reach
11 countries

79 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2022

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

June 23, 2020

Last Update Submit

February 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score

    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.

    From baseline to Week 8

Secondary Outcomes (15)

  • Remission (defined as a MADRS total score =<10)

    At Week 8

  • Response (defined as a => 50% decrease from baseline in MADRS total score)

    At Week 8

  • Change in MADRS anhedonia factor score

    From baseline to Week 8

  • Change in Digital Symbol Substitution Test (DSST) total score

    From baseline to Week 8

  • The proportion number of Hard Choice/number of High Reward trials and number of Low choice/number of Low Reward trials when performing the Effort- Expenditure for Rewards Task (EEfRT)

    From baseline to Week 8

  • +10 more secondary outcomes

Study Arms (2)

Vortioxetine

EXPERIMENTAL

8 weeks treatment

Drug: Vortioxetine

Desvenlafaxine

ACTIVE COMPARATOR

8 weeks treatment

Drug: Desvenlafaxine

Interventions

10 or 20 mg/day, capsules, orally

Vortioxetine

50 mg/day capsules, orally

Desvenlafaxine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (80)

Clinica Privada Banfield

Banfield, Buenos Aires, B1828CKR, Argentina

Location

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

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1058AAJ, Argentina

Location

Fundacion para el Estudio y Tratamiento de las enfermedades mentales FETEM

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1133AAH, Argentina

Location

INAPsi (Instituto Nacional de Psicopatologia)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BOA, Argentina

Location

Clinica Privada De Salud Mental Santa Teresa De Avila

La Plata, Buenos Aires, 1900, Argentina

Location

Instituto De Neurociencias San Agustin SA

La Plata, Buenos Aires, B1900BHE, Argentina

Location

Sanatorio Prof. Leon S. Morra S.A.

Córdoba, Providencia de Cordo, X5009BIN, Argentina

Location

CIAP (Centro de Investigacion y Asistencia en Psiquiatria)

Rosario, Santa Fe Province, 2000, Argentina

Location

CINME (Centro de Investigaciones Metabolicas de Buenos Aires)

Buenos Aires, C1056ABJ, Argentina

Location

CEN (Centro Especializado Neurociencias)

Córdoba, 5000, Argentina

Location

Instituto Modelo de Neurologia Fundacion Lennox

Córdoba, X5000FAL, Argentina

Location

Instituto Medico DAMIC - Fundacion Rusculleda

Córdoba, X5003DCE, Argentina

Location

Centro De Asistencia E Investigacion En Neurociencias CENAIN

Mendoza, 5500, Argentina

Location

Resolution Psicopharmacology Research Institute

Mendoza, M5500BCR, Argentina

Location

Algemeen Ziekenhuis St. Lucas-St. Jozef

Bruges, 8310, Belgium

Location

SINAPS - University Antwerpe- Psychiatrisch Ziekenhuis Duffel

Duffel, 2570, Belgium

Location

Cliniques De Mont-Godinne

Yvoir, 5530, Belgium

Location

MHAT Dr. Hristo Stambolski

Kazanlak, 6100, Bulgaria

Location

UMHAT Sv. Ivan Rilski EAD

Plovdiv, 4002, Bulgaria

Location

Center For Mental Health-Rousse

Rousse, 7003, Bulgaria

Location

MC Complete Medical Solutions

Samokov, 2000, Bulgaria

Location

Centre for Mental Health- Sofia

Sofia, 1202, Bulgaria

Location

Diagnostic Consultative Center Mladost-M Varna OOD

Varna, 9020, Bulgaria

Location

Clintrial s.r.o.

Prague, Prague 10, 100 00, Czechia

Location

Dr.Jan Holan MD, Office of

Brno, 61500, Czechia

Location

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

Havířov, 73601, Czechia

Location

Clinline services s.r.o.

Hostivice, 25301, Czechia

Location

Neuropsychiatrie HK, s.r.o.

Hradec Králové, 50009, Czechia

Location

National Institute of Mental Health

Klecany, 25067, Czechia

Location

Psychiatricka Ambulance

Kutná Hora, 28401, Czechia

Location

A-Shine s.r.o.

Pilsen, 31200, Czechia

Location

Institut neuropsychiatricke pece

Prague, 18600, Czechia

Location

Marienthali Kliinik

Tallinn, 11315, Estonia

Location

Psihiatrijas Centrs

Liepāja, Liepajas Rajons, 3401, Latvia

Location

Riga Centre Of Psychiatry And Addiction Disorders

Riga, 1005, Latvia

Location

Sigulda Hospital Outpatient Clinic

Sigulda, LV-2150, Latvia

Location

CRI Centro Regiomontano de Investigacion SC

Monterrey, Nuevo León, 64060, Mexico

Location

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

Mérida, Yucatán, 97070, Mexico

Location

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

Mexico City, 03100, Mexico

Location

Region Specialized Psychiatric Hospital No.2

Stavropol Region, Kochubeev District, 357034, Russia

Location

Leningrad Regional Psychoneurological Dispensary

Roshchino, Leningradskaya Oblast', 188820, Russia

Location

Arkhangelsk Regional Clinical Mental Hospital

Arkhangelsk, 163530, Russia

Location

GUZ Engels Psychiatric Hospital

Engel's, 413124, Russia

Location

Moscow Scientific Research Institute of Psychiatry

Moscow, 107076, Russia

Location

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

Moscow, 125284, Russia

Location

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

Nizhny Novgorod, 603155, Russia

Location

Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

Rostov-on-Don, 344022, Russia

Location

LLC Medical Center Nova Vita

Rostov-on-Don, 344082, Russia

Location

St. Nicolas State Psychiatric Hospital

Saint Petersburg, 190121, Russia

Location

Hospital OrKli , LLC

Saint Petersburg, 199178, Russia

Location

LLC Astarta

Saint Petersburg, 199226, Russia

Location

Saratov State Medical University

Saratov, 410028, Russia

Location

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

Smolensk, 214019, Russia

Location

Yaroslavl Regional Clinical Psychiatry Hospital

Yaroslavl, 150003, Russia

Location

Psychiatricka ambulancia, MENTUM, s.r.o.

Bratislava, 82007, Slovakia

Location

Epamed, S.R.O

Košice, 040 01, Slovakia

Location

Psycholine S.R.O.

Rimavská Sobota, 97901, Slovakia

Location

Crystal Comfort, s.r.o.

Vranov Nad Topou, 09301, Slovakia

Location

BONA MEDIC s.r.o.

Zlaté Moravce, 95301, Slovakia

Location

Psychiatricka Ambulancia

Zlaté Moravce, 95301, Slovakia

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Centro De Salud Mental La Corredoria

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hospital Psiquiatric de Palma de Mallorca

Palma de Mallorca, 07011, Spain

Location

Smaert & Psykiatricentrum Malmoe

Malmo, Skåne County, 21137, Sweden

Location

Affecta Psyikiatri AB

Halmstad, 302 48, Sweden

Location

ProbarE i Lund

Lund, 22222, Sweden

Location

ONE LIFETIME Lakarmottagning

Skövde, 541 50, Sweden

Location

ProbarE

Stockholm, 11329, Sweden

Location

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

Smila, Cherkasy Oblast, 20708, Ukraine

Location

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

Kharkiv, Kharkivska, 61068, Ukraine

Location

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

Kominternivskyy, Odesa Oblast, 67513, Ukraine

Location

CI of KRC Regional psychiatric and narcological medical association

Hlevakha, 8631, Ukraine

Location

Ivano-Frankivsk Oblast neuropsychiatric hospital No. 3

Ivano-Frankivsk, 76014, Ukraine

Location

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

Kharkiv, 61068, Ukraine

Location

SI INPN Namsu

Kharkiv, 61068, Ukraine

Location

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

Lviv, 79021, Ukraine

Location

Odessa Regional Medical Centre of Mental Health

Odesa, 65006, Ukraine

Location

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

Poltava, 36006, Ukraine

Location

Vinnitsa National Medical University

Vinnitsa, 21005, Ukraine

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

VortioxetineDesvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticLipids

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 25, 2020

Study Start

June 18, 2020

Primary Completion

January 6, 2022

Study Completion

February 4, 2022

Last Updated

February 14, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Locations