Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression

Major Depressive Disorder Clinical Trial

— VIVRE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448431
• Other study ID #: 18498A
• Status: Completed
• Phase: Phase 4
• Start date: June 18, 2020
• Est. completion date: February 4, 2022

Study information

• Verified date: February 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: February 4, 2022
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine
10 or 20 mg/day, capsules, orally
• Desvenlafaxine
50 mg/day capsules, orally

Locations

Country	Name	City	State
Argentina	Clinica Privada Banfield	Banfield	Buenos Aires
Argentina	Cenydet-Centro Neurobiologico Y De Estres Traumatico-Biopsychomedical Research Group Srl	Ciudad Autonoma De Buenos Aires	Buenos Aires
Argentina	CINME (Centro de Investigaciones Metabolicas de Buenos Aires)	Ciudad Autonoma De Buenos Aires
Argentina	Fundacion para el Estudio y Tratamiento de las enfermedades mentales FETEM	Ciudad Autonoma De Buenos Aires	Buenos Aires
Argentina	INAPsi (Instituto Nacional de Psicopatologia)	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	CEN (Centro Especializado Neurociencias)	Cordoba
Argentina	Instituto Medico DAMIC - Fundacion Rusculleda	Cordoba
Argentina	Instituto Modelo de Neurologia Fundacion Lennox	Cordoba
Argentina	Sanatorio Prof. Leon S. Morra S.A.	Cordoba	Providencia De Cordo
Argentina	Clinica Privada De Salud Mental Santa Teresa De Avila	La Plata	Buenos Aires
Argentina	Instituto De Neurociencias San Agustin SA	La Plata	Buenos Aires
Argentina	Centro De Asistencia E Investigacion En Neurociencias CENAIN	Mendoza
Argentina	Resolution Psicopharmacology Research Institute	Mendoza
Argentina	CIAP (Centro de Investigacion y Asistencia en Psiquiatria)	Rosario	Santa Fe
Belgium	Algemeen Ziekenhuis St. Lucas-St. Jozef	Brugge
Belgium	SINAPS - University Antwerpe- Psychiatrisch Ziekenhuis Duffel	Duffel
Belgium	Cliniques De Mont-Godinne	Yvoir
Bulgaria	MHAT Dr. Hristo Stambolski	Kazanlak
Bulgaria	UMHAT Sv. Ivan Rilski EAD	Plovdiv
Bulgaria	Center For Mental Health-Rousse	Rousse
Bulgaria	MC Complete Medical Solutions	Samokov
Bulgaria	Centre for Mental Health- Sofia	Sofia
Bulgaria	Diagnostic Consultative Center Mladost-M Varna OOD	Varna
Czechia	Dr.Jan Holan MD, Office of	Brno
Czechia	Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum	Havirov
Czechia	Clinline services s.r.o.	Hostivice
Czechia	Neuropsychiatrie HK, s.r.o.	Hradec Kralove
Czechia	National Institute of Mental Health	Klecany
Czechia	Psychiatricka Ambulance	Kutna Hora
Czechia	A-Shine s.r.o.	Plzen
Czechia	Clintrial s.r.o.	Prague	Prague 10
Czechia	Institut neuropsychiatricke pece	Praha 8
Estonia	Marienthali Kliinik	Tallinn
Latvia	Psihiatrijas Centrs	Liepaja	Liepajas Rajons
Latvia	Riga Centre Of Psychiatry And Addiction Disorders	Riga
Latvia	Sigulda Hospital Outpatient Clinic	Sigulda
Mexico	Health Pharma Professional Research S.A. de C.V.	Ciudad de Mexico
Mexico	Medical Care and Research S.A. de C.V.	Merida	Yucatan
Mexico	CRI Centro Regiomontano de Investigacion SC	Monterrey	Nuevo Leon
Russian Federation	Arkhangelsk Regional Clinical Mental Hospital	Arkhangelsk
Russian Federation	GUZ Engels Psychiatric Hospital	Engels
Russian Federation	Clinic named after professor Yu. N. Kasatkin FGBOU DPO RMANPO Minzdrava Rossii	Moscow
Russian Federation	Moscow Scientific Research Institute of Psychiatry	Moscow
Russian Federation	Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...	Nizhny Novgorod
Russian Federation	Leningrad Regional Psychoneurological Dispensary	Roshchino	Leningrad Region
Russian Federation	LLC Medical Center Nova Vita	Rostov-on-Don
Russian Federation	Rostov State Medical University of the Minzdravsotsrazvitiya of Russia	Rostov-on-Don
Russian Federation	Hospital OrKli , LLC	Saint-Petersburg
Russian Federation	LLC Astarta	Saint-Petersburg
Russian Federation	Saratov State Medical University	Saratov
Russian Federation	State Budgetery Educational Institution Of Higher Professional Education Smolensk State Medical U...	Smolensk
Russian Federation	St. Nicolas State Psychiatric Hospital	St. Petersburg
Russian Federation	Region Specialized Psychiatric Hospital No.2	Stavropol Region	Kochubeev District
Russian Federation	Yaroslavl Regional Clinical Psychiatry Hospital	Yaroslavl
Slovakia	Psychiatricka ambulancia, MENTUM, s.r.o.	Bratislava
Slovakia	Epamed, S.R.O	Kosice
Slovakia	Psycholine S.R.O.	Rimavska Sobota
Slovakia	Crystal Comfort, s.r.o.	Vranov Nad Topou
Slovakia	BONA MEDIC s.r.o.	Zlate Moravce
Slovakia	Psychiatricka Ambulancia	Zlate Moravce
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcon	Madrid
Spain	Hospital De La Santa Creu I Sant Pau	Barcelona
Spain	Centro De Salud Mental La Corredoria	Oviedo	Asturias
Spain	Hospital Psiquiatric de Palma de Mallorca	Palma de Mallorca
Sweden	Affecta Psyikiatri AB	Halmstad
Sweden	ProbarE i Lund	Lund
Sweden	Smaert & Psykiatricentrum Malmoe	Malmo	Skane
Sweden	ONE LIFETIME Lakarmottagning	Skövde
Sweden	ProbarE	Stockholm
Ukraine	CI of KRC Regional psychiatric and narcological medical association	Glevakha
Ukraine	Ivano-Frankivsk Oblast neuropsychiatric hospital No. 3	Ivano-Frankivsk
Ukraine	Academy of Medical Sciences of Ukraine - Institute of Neurology, Psychiatry and Narcology	Kharkiv
Ukraine	Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional clinical psychiatric hosp...	Kharkiv	Kharkivska
Ukraine	SI INPN Namsu	Kharkiv
Ukraine	Municipal Non-profit Enterprise Odesa Regional Psychiatric Hospital No.2 of Odesa Regional Council	Kominternivskyy	Odesa
Ukraine	Lviv Regional State Clinical Psychiatric Hospital, Lviv Danylo Galytsky National Medical University	Lviv
Ukraine	Odessa Regional Medical Centre of Mental Health	Odessa
Ukraine	Ukrainian Medical Stomatological Academy, Chair Of Psychiatry, Narcology And Medical Psychology B...	Poltava
Ukraine	Communal Non-commercial Enterprise Cherkasy regional psychiatric hospital of Cherkasy regional co...	Smila	Cherkasy
Ukraine	Vinnitsa National Medical University	Vinnitsa

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Argentina,  Belgium,  Bulgaria,  Czechia,  Estonia,  Latvia,  Mexico,  Russian Federation,  Slovakia,  Spain,  Sweden,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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