Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression (VIVRE)

A Randomised, Double-blind, Parallel-group, Active Controlled Study Evaluating the Efficacy of Vortioxetine Versus Desvenlafaxine in Adult Patients Suffering From Major Depressive Disorder With Partial Response to SSRI Treatment

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Vortioxetine; Drug: Desvenlafaxine

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 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.

• Study Type: Interventional
• Enrollment (Actual): 605
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma De Buenos Aires, Argentina, C1056ABJ
    • CINME (Centro de Investigaciones Metabolicas de Buenos Aires)
  • Cordoba, Argentina, 5000
    • CEN (Centro Especializado Neurociencias)
  • Cordoba, Argentina, X5000FAL
    • Instituto Modelo de Neurologia Fundacion Lennox
  • Cordoba, Argentina, X5003DCE
    • Instituto Medico DAMIC - Fundacion Rusculleda
  • Mendoza, Argentina, 5500
    • Centro De Asistencia E Investigacion En Neurociencias CENAIN
  • Mendoza, Argentina, M5500BCR
    • Resolution Psicopharmacology Research Institute
  • Buenos Aires
    • Banfield, Buenos Aires, Argentina, B1828CKR
      • Clínica Privada Banfield
    • Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1058AAJ
      • Cenydet-Centro Neurobiologico Y De Estres Traumatico-Biopsychomedical Research Group Srl
    • Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1133AAH
      • Fundacion para el Estudio y Tratamiento de las enfermedades mentales FETEM
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BOA
      • INAPsi (Instituto Nacional de Psicopatologia)
    • La Plata, Buenos Aires, Argentina, 1900
      • Clinica Privada de Salud Mental Santa Teresa de Ávila
    • La Plata, Buenos Aires, Argentina, B1900BHE
      • Instituto De Neurociencias San Agustin SA
  • Providencia De Cordo
    • Cordoba, Providencia De Cordo, Argentina, X5009BIN
      • Sanatorio Prof. Leon S. Morra S.A.
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • CIAP (Centro de Investigacion y Asistencia en Psiquiatria)
• Belgium
  • Brugge, Belgium, 8310
    • Algemeen Ziekenhuis St. Lucas-St. Jozef
  • Duffel, Belgium, 2570
    • SINAPS - University Antwerpe- Psychiatrisch Ziekenhuis Duffel
  • Yvoir, Belgium, 5530
    • Cliniques De Mont-Godinne
• Bulgaria
  • Kazanlak, Bulgaria, 6100
    • MHAT Dr. Hristo Stambolski
  • Plovdiv, Bulgaria, 4002
    • Umhat Sv. Ivan Rilski Ead
  • Rousse, Bulgaria, 7003
    • Center For Mental Health-Rousse
  • Samokov, Bulgaria, 2000
    • MC Complete Medical Solutions
  • Sofia, Bulgaria, 1202
    • Centre for Mental Health- Sofia
  • Varna, Bulgaria, 9020
    • Diagnostic Consultative Center Mladost-M Varna OOD
• Czechia
  • Brno, Czechia, 61500
    • Dr.Jan Holan MD, Office of
  • Havirov, Czechia, 73601
    • Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum
  • Hostivice, Czechia, 25301
    • Clinline Services s.r.o.
  • Hradec Kralove, Czechia, 50009
    • Neuropsychiatrie HK, s.r.o.
  • Klecany, Czechia, 25067
    • National Institute of Mental Health
  • Kutna Hora, Czechia, 28401
    • Psychiatricka ambulance
  • Plzen, Czechia, 31200
    • A-Shine s.r.o.
  • Praha 8, Czechia, 18600
    • Institut Neuropsychiatricke pece
  • Prague 10
    • Prague, Prague 10, Czechia, 100 00
      • Clintrial s.r.o.
• Estonia
  • Tallinn, Estonia, 11315
    • Marienthali Kliinik
• Latvia
  • Riga, Latvia, 1005
    • Riga Centre Of Psychiatry And Addiction Disorders
  • Sigulda, Latvia, LV-2150
    • Sigulda Hospital Outpatient Clinic
  • Liepajas Rajons
    • Liepaja, Liepajas Rajons, Latvia, 3401
      • Psihiatrijas Centrs
• Mexico
  • Ciudad de Mexico, Mexico, 03100
    • Health Pharma Professional Research S.A. de C.V.
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64060
      • CRI Centro Regiomontano de Investigacion SC
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Medical Care and Research S.A. de C.V.
• Russian Federation
  • Arkhangelsk, Russian Federation, 163530
    • Arkhangelsk Regional Clinical Mental Hospital
  • Engels, Russian Federation, 413124
    • GUZ Engels Psychiatric Hospital
  • Moscow, Russian Federation, 107076
    • Moscow Scientific Research Institute of Psychiatry
  • Moscow, Russian Federation, 125284
    • Clinic named after professor Yu. N. Kasatkin FGBOU DPO RMANPO Minzdrava Rossii
  • Nizhny Novgorod, Russian Federation, 603155
    • Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...
  • Rostov-on-Don, Russian Federation, 344022
    • Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
  • Rostov-on-Don, Russian Federation, 344082
    • LLC Medical Center Nova Vita
  • Saint-Petersburg, Russian Federation, 199178
    • Hospital OrKli , LLC
  • Saint-Petersburg, Russian Federation, 199226
    • LLC Astarta
  • Saratov, Russian Federation, 410028
    • Saratov State Medical University
  • Smolensk, Russian Federation, 214019
    • State Budgetery Educational Institution Of Higher Professional Education Smolensk State Medical U...
  • St. Petersburg, Russian Federation, 190121
    • St. Nicolas State Psychiatric Hospital
  • Yaroslavl, Russian Federation, 150003
    • Yaroslavl Regional Clinical Psychiatry Hospital
  • Kochubeev District
    • Stavropol Region, Kochubeev District, Russian Federation, 357034
      • Region Specialized Psychiatric Hospital No.2
  • Leningrad Region
    • Roshchino, Leningrad Region, Russian Federation, 188820
      • Leningrad Regional Psychoneurological Dispensary
• Slovakia
  • Bratislava, Slovakia, 82007
    • Psychiatricka ambulancia, Mentum, s.r.o.
  • Kosice, Slovakia, 040 01
    • Epamed, S.R.O
  • Rimavska Sobota, Slovakia, 97901
    • PsychoLine s.r.o.
  • Vranov Nad Topou, Slovakia, 09301
    • Crystal Comfort, s.r.o.
  • Zlate Moravce, Slovakia, 95301
    • BONA MEDIC s.r.o.
  • Zlate Moravce, Slovakia, 95301
    • Psychiatricka ambulancia
• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Palma de Mallorca, Spain, 07011
    • Hospital Psiquiatric de Palma de Mallorca
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Centro de Salud Mental La Corredoria
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon
• Sweden
  • Halmstad, Sweden, 302 48
    • Affecta Psyikiatri AB
  • Lund, Sweden, 22222
    • ProbarE i Lund
  • Skövde, Sweden, 541 50
    • ONE LIFETIME Lakarmottagning
  • Stockholm, Sweden, 11329
    • ProbarE
  • Skane
    • Malmo, Skane, Sweden, 21137
      • Smaert & Psykiatricentrum Malmoe
• Ukraine
  • Glevakha, Ukraine, 8631
    • CI of KRC Regional psychiatric and narcological medical association
  • Ivano-Frankivsk, Ukraine, 76014
    • Ivano-Frankivsk Oblast neuropsychiatric hospital No. 3
  • Kharkiv, Ukraine, 61068
    • Academy of Medical Sciences of Ukraine - Institute of Neurology, Psychiatry and Narcology
  • Kharkiv, Ukraine, 61068
    • SI INPN Namsu
  • Lviv, Ukraine, 79021
    • Lviv Regional State Clinical Psychiatric Hospital, Lviv Danylo Galytsky National Medical University
  • Odessa, Ukraine, 65006
    • Odessa Regional Medical Centre of Mental Health
  • Poltava, Ukraine, 36006
    • Ukrainian Medical Stomatological Academy, Chair Of Psychiatry, Narcology And Medical Psychology B...
  • Vinnitsa, Ukraine, 21005
    • Vinnitsa National Medical University
  • Cherkasy
    • Smila, Cherkasy, Ukraine, 20708
      • Communal Non-commercial Enterprise Cherkasy regional psychiatric hospital of Cherkasy regional co...
  • Kharkivska
    • Kharkiv, Kharkivska, Ukraine, 61068
      • Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional clinical psychiatric hosp...
  • Odesa
    • Kominternivskyy, Odesa, Ukraine, 67513
      • Municipal Non-profit Enterprise Odesa Regional Psychiatric Hospital No.2 of Odesa Regional Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Other in- and exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vortioxetine; 8 weeks treatment	Drug: Vortioxetine; 10 or 20 mg/day, capsules, orally
Active Comparator: Desvenlafaxine; 8 weeks treatment	Drug: Desvenlafaxine; 50 mg/day capsules, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission (defined as a MADRS total score =<10)	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.	At Week 8
Response (defined as a => 50% decrease from baseline in 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.	At Week 8
Change in MADRS anhedonia factor score	(based on items 1(apparent sadness),2 (reported sadness),6 (concentration difficulties),7 (lassitude),8 (inability to feel))	From baseline to Week 8
Change in Digital Symbol Substitution Test (DSST) total score	DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (< normal functioning) to 133 (> normal functioning).	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)	The EEfRT is a computerized task which measures reward motivation in which participants are presented with a series of repeated trials during which they choose between performing a ''hard-task'' or an ''easy-task'' in order to earn varying amounts of monetary rewards.	From baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S) score	The CGI-S scale measures the severity of psychiatric symptoms on a 7-point scale from 1-7. The scores indicated the following: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The score ranged from 1-7, where 1 indicated absence of symptoms and higher score indicated greater severity of symptoms.	from baseline to Week 8
Clinical Global Impression Scale- Global Improvement (CGI-I) score	The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse)	at Day 7,28,56
Change in Functioning Assessment Short Test (FAST) total score	The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time	From baseline to Week 8
Change in FAST sub-domain scores	The FAST is a clinician-rated scale designed to assess difficulty in functioning. The FAST consists of 24 items in 6 specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, leisure time. Each item is rated on a 4-point scale from 0 (no difficulty) to 3 (severe difficulty). The items are summed to yield a total score ranging from 0 to 72 with higher scores reflecting more serious difficulties.	From baseline to Week 8
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score	The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)	From baseline to Week 8
Change in Q-LES-Q work subscale	The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)	From baseline to Week 8
Change in Q-LES-Q household duties subscale	The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)	From baseline to Week 8
Change in Q-LES-Q school/course subscale	The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)	From baseline to Week 8
Change in Q-LES-Q leisure time activities subscale	The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)	From baseline to Week 8
Change in Q-LES-Q social relations subscale	The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)	From baseline to Week 8

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): January 6, 2022
• Study Completion (Actual): February 4, 2022

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine; Desvenlafaxine Succinate
• Other Study ID Numbers: 18498A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No