Clinical trial NCT04448431: Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
timeFrame: From baseline to Week 8
Secondary outcomes:
measure: Remission (defined as a MADRS total score =<10)
timeFrame: At Week 8
measure: Response (defined as a => 50% decrease from baseline in MADRS total score)
timeFrame: At Week 8
measure: Change in MADRS anhedonia factor score
timeFrame: From baseline to Week 8
measure: Change in Digital Symbol Substitution Test (DSST) total score
timeFrame: From baseline to Week 8
measure: 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)
timeFrame: From baseline to Week 8
measure: Change in Clinical Global Impression - Severity of Illness (CGI-S) score
timeFrame: from baseline to Week 8
measure: Clinical Global Impression Scale- Global Improvement (CGI-I) score
timeFrame: at Day 7,28,56
measure: Change in Functioning Assessment Short Test (FAST) total score
timeFrame: From baseline to Week 8
measure: Change in FAST sub-domain scores
timeFrame: From baseline to Week 8
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score
timeFrame: From baseline to Week 8
measure: Change in Q-LES-Q work subscale
timeFrame: From baseline to Week 8
measure: Change in Q-LES-Q household duties subscale
timeFrame: From baseline to Week 8
measure: Change in Q-LES-Q school/course subscale
timeFrame: From baseline to Week 8
measure: Change in Q-LES-Q leisure time activities subscale
timeFrame: From baseline to Week 8
measure: Change in Q-LES-Q social relations subscale
timeFrame: From baseline to Week 8
Other outcomes:
Locations:
city: Banfield
country: Argentina
facility: Clinica Privada Banfield
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aires
country: Argentina
facility: Cenydet-Centro Neurobiologico Y De Estres Traumatico-Biopsychomedical Research Group Srl
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aires
country: Argentina
facility: Fundacion para el Estudio y Tratamiento de las enfermedades mentales FETEM
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: INAPsi (Instituto Nacional de Psicopatologia)
state: Buenos Aires
city: La Plata
country: Argentina
facility: Clinica Privada De Salud Mental Santa Teresa De Avila
state: Buenos Aires
city: La Plata
country: Argentina
facility: Instituto De Neurociencias San Agustin SA
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Sanatorio Prof. Leon S. Morra S.A.
state: Providencia De Cordo
city: Rosario
country: Argentina
facility: CIAP (Centro de Investigacion y Asistencia en Psiquiatria)
state: Santa Fe
city: Ciudad Autonoma De Buenos Aires
country: Argentina
facility: CINME (Centro de Investigaciones Metabolicas de Buenos Aires)
city: Cordoba
country: Argentina
facility: CEN (Centro Especializado Neurociencias)
city: Cordoba
country: Argentina
facility: Instituto Modelo de Neurologia Fundacion Lennox
city: Cordoba
country: Argentina
facility: Instituto Medico DAMIC - Fundacion Rusculleda
city: Mendoza
country: Argentina
facility: Centro De Asistencia E Investigacion En Neurociencias CENAIN
city: Mendoza
country: Argentina
facility: Resolution Psicopharmacology Research Institute
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis St. Lucas-St. Jozef
city: Duffel
country: Belgium
facility: SINAPS - University Antwerpe- Psychiatrisch Ziekenhuis Duffel
city: Yvoir
country: Belgium
facility: Cliniques De Mont-Godinne
city: Kazanlak
country: Bulgaria
facility: MHAT Dr. Hristo Stambolski
city: Plovdiv
country: Bulgaria
facility: UMHAT Sv. Ivan Rilski EAD
city: Rousse
country: Bulgaria
facility: Center For Mental Health-Rousse
city: Samokov
country: Bulgaria
facility: MC Complete Medical Solutions
city: Sofia
country: Bulgaria
facility: Centre for Mental Health- Sofia
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Center Mladost-M Varna OOD
city: Prague
country: Czechia
facility: Clintrial s.r.o.
state: Prague 10
city: Brno
country: Czechia
facility: Dr.Jan Holan MD, Office of
city: Havirov
country: Czechia
facility: Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum
city: Hostivice
country: Czechia
facility: Clinline services s.r.o.
city: Hradec Kralove
country: Czechia
facility: Neuropsychiatrie HK, s.r.o.
city: Klecany
country: Czechia
facility: National Institute of Mental Health
city: Kutna Hora
country: Czechia
facility: Psychiatricka Ambulance
city: Plzen
country: Czechia
facility: A-Shine s.r.o.
city: Praha 8
country: Czechia
facility: Institut neuropsychiatricke pece
city: Tallinn
country: Estonia
facility: Marienthali Kliinik
city: Liepaja
country: Latvia
facility: Psihiatrijas Centrs
state: Liepajas Rajons
city: Riga
country: Latvia
facility: Riga Centre Of Psychiatry And Addiction Disorders
city: Sigulda
country: Latvia
facility: Sigulda Hospital Outpatient Clinic
city: Monterrey
country: Mexico
facility: CRI Centro Regiomontano de Investigacion SC
state: Nuevo Leon
city: Merida
country: Mexico
facility: Medical Care and Research S.A. de C.V.
state: Yucatan
city: Ciudad de Mexico
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V.
city: Stavropol Region
country: Russian Federation
facility: Region Specialized Psychiatric Hospital No.2
state: Kochubeev District
city: Roshchino
country: Russian Federation
facility: Leningrad Regional Psychoneurological Dispensary
state: Leningrad Region
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Mental Hospital
city: Engels
country: Russian Federation
facility: GUZ Engels Psychiatric Hospital
city: Moscow
country: Russian Federation
facility: Moscow Scientific Research Institute of Psychiatry
city: Moscow
country: Russian Federation
facility: Clinic named after professor Yu. N. Kasatkin FGBOU DPO RMANPO Minzdrava Rossii
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
city: Rostov-on-Don
country: Russian Federation
facility: LLC Medical Center Nova Vita
city: Saint-Petersburg
country: Russian Federation
facility: Hospital OrKli , LLC
city: Saint-Petersburg
country: Russian Federation
facility: LLC Astarta
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: Smolensk
country: Russian Federation
facility: State Budgetery Educational Institution Of Higher Professional Education Smolensk State Medical U...
city: St. Petersburg
country: Russian Federation
facility: St. Nicolas State Psychiatric Hospital
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Psychiatry Hospital
city: Bratislava
country: Slovakia
facility: Psychiatricka ambulancia, MENTUM, s.r.o.
city: Kosice
country: Slovakia
facility: Epamed, S.R.O
city: Rimavska Sobota
country: Slovakia
facility: Psycholine S.R.O.
city: Vranov Nad Topou
country: Slovakia
facility: Crystal Comfort, s.r.o.
city: Zlate Moravce
country: Slovakia
facility: BONA MEDIC s.r.o.
city: Zlate Moravce
country: Slovakia
facility: Psychiatricka Ambulancia
city: Oviedo
country: Spain
facility: Centro De Salud Mental La Corredoria
state: Asturias
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Palma de Mallorca
country: Spain
facility: Hospital Psiquiatric de Palma de Mallorca
city: Malmo
country: Sweden
facility: Smaert & Psykiatricentrum Malmoe
state: Skane
city: Halmstad
country: Sweden
facility: Affecta Psyikiatri AB
city: Lund
country: Sweden
facility: ProbarE i Lund
city: Skövde
country: Sweden
facility: ONE LIFETIME Lakarmottagning
city: Stockholm
country: Sweden
facility: ProbarE
city: Smila
country: Ukraine
facility: Communal Non-commercial Enterprise Cherkasy regional psychiatric hospital of Cherkasy regional co...
state: Cherkasy
city: Kharkiv
country: Ukraine
facility: Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional clinical psychiatric hosp...
state: Kharkivska
city: Kominternivskyy
country: Ukraine
facility: Municipal Non-profit Enterprise Odesa Regional Psychiatric Hospital No.2 of Odesa Regional Council
state: Odesa
city: Glevakha
country: Ukraine
facility: CI of KRC Regional psychiatric and narcological medical association
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Oblast neuropsychiatric hospital No. 3
city: Kharkiv
country: Ukraine
facility: Academy of Medical Sciences of Ukraine - Institute of Neurology, Psychiatry and Narcology
city: Kharkiv
country: Ukraine
facility: SI INPN Namsu
city: Lviv
country: Ukraine
facility: Lviv Regional State Clinical Psychiatric Hospital, Lviv Danylo Galytsky National Medical University
city: Odessa
country: Ukraine
facility: Odessa Regional Medical Centre of Mental Health
city: Poltava
country: Ukraine
facility: Ukrainian Medical Stomatological Academy, Chair Of Psychiatry, Narcology And Medical Psychology B...
city: Vinnitsa
country: Ukraine
facility: Vinnitsa National Medical University
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: