Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT04448431
- Lead Sponsor
- H. Lundbeck A/S
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 605
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Desvenlafaxine Desvenlafaxine 8 weeks treatment Vortioxetine Vortioxetine 8 weeks treatment
- Primary Outcome Measures
Name Time Method Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score From baseline to Week 8 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.
- Secondary Outcome Measures
Name Time Method Remission (defined as a MADRS total score =<10) At Week 8 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.
Change in Digital Symbol Substitution Test (DSST) total score From baseline to Week 8 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).
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score From baseline to Week 8 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)
Change in Q-LES-Q work subscale From baseline to Week 8 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)
Change in Q-LES-Q school/course subscale From baseline to Week 8 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)
Change in Q-LES-Q leisure time activities subscale From baseline to Week 8 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)
Change in MADRS anhedonia factor score From baseline to Week 8 (based on items 1(apparent sadness),2 (reported sadness),6 (concentration difficulties),7 (lassitude),8 (inability to feel))
Clinical Global Impression Scale- Global Improvement (CGI-I) score at Day 7,28,56 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)
Response (defined as a => 50% decrease from baseline in MADRS total score) At Week 8 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.
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 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.
Change in Clinical Global Impression - Severity of Illness (CGI-S) score from baseline to Week 8 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.
Change in Functioning Assessment Short Test (FAST) total score From baseline to Week 8 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
Change in FAST sub-domain scores From baseline to Week 8 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.
Change in Q-LES-Q household duties subscale From baseline to Week 8 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)
Change in Q-LES-Q social relations subscale From baseline to Week 8 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)
Trial Locations
- Locations (80)
INAPsi (Instituto Nacional de Psicopatologia)
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
CRI Centro Regiomontano de Investigacion SC
🇲🇽Monterrey, Nuevo Leon, Mexico
Leningrad Regional Psychoneurological Dispensary
🇷🇺Roshchino, Leningrad Region, Russian Federation
Yaroslavl Regional Clinical Psychiatry Hospital
🇷🇺Yaroslavl, Russian Federation
MC Complete Medical Solutions
🇧🇬Samokov, Bulgaria
Health Pharma Professional Research S.A. de C.V.
🇲🇽Ciudad de Mexico, Mexico
SI INPN Namsu
🇺🇦Kharkiv, Ukraine
LLC Astarta
🇷🇺Saint-Petersburg, Russian Federation
Epamed, S.R.O
🇸🇰Kosice, Slovakia
Psycholine S.R.O.
🇸🇰Rimavska Sobota, Slovakia
Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional clinical psychiatric hosp...
🇺🇦Kharkiv, Kharkivska, Ukraine
Crystal Comfort, s.r.o.
🇸🇰Vranov Nad Topou, Slovakia
Psychiatricka Ambulancia
🇸🇰Zlate Moravce, Slovakia
BONA MEDIC s.r.o.
🇸🇰Zlate Moravce, Slovakia
ONE LIFETIME Lakarmottagning
🇸🇪Skövde, Sweden
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
Fundacion para el Estudio y Tratamiento de las enfermedades mentales FETEM
🇦🇷Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Clinica Privada De Salud Mental Santa Teresa De Avila
🇦🇷La Plata, Buenos Aires, Argentina
Sanatorio Prof. Leon S. Morra S.A.
🇦🇷Cordoba, Providencia De Cordo, Argentina
Instituto De Neurociencias San Agustin SA
🇦🇷La Plata, Buenos Aires, Argentina
CIAP (Centro de Investigacion y Asistencia en Psiquiatria)
🇦🇷Rosario, Santa Fe, Argentina
CINME (Centro de Investigaciones Metabolicas de Buenos Aires)
🇦🇷Ciudad Autonoma De Buenos Aires, Argentina
CEN (Centro Especializado Neurociencias)
🇦🇷Cordoba, Argentina
Instituto Medico DAMIC - Fundacion Rusculleda
🇦🇷Cordoba, Argentina
Instituto Modelo de Neurologia Fundacion Lennox
🇦🇷Cordoba, Argentina
Centro De Asistencia E Investigacion En Neurociencias CENAIN
🇦🇷Mendoza, Argentina
Resolution Psicopharmacology Research Institute
🇦🇷Mendoza, Argentina
Algemeen Ziekenhuis St. Lucas-St. Jozef
🇧🇪Brugge, Belgium
SINAPS - University Antwerpe- Psychiatrisch Ziekenhuis Duffel
🇧🇪Duffel, Belgium
Cliniques De Mont-Godinne
🇧🇪Yvoir, Belgium
MHAT Dr. Hristo Stambolski
🇧🇬Kazanlak, Bulgaria
UMHAT Sv. Ivan Rilski EAD
🇧🇬Plovdiv, Bulgaria
Center For Mental Health-Rousse
🇧🇬Rousse, Bulgaria
Centre for Mental Health- Sofia
🇧🇬Sofia, Bulgaria
Diagnostic Consultative Center Mladost-M Varna OOD
🇧🇬Varna, Bulgaria
Clinline services s.r.o.
🇨🇿Hostivice, Czechia
Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum
🇨🇿Havirov, Czechia
Clintrial s.r.o.
🇨🇿Prague, Prague 10, Czechia
Dr.Jan Holan MD, Office of
🇨🇿Brno, 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
Institut neuropsychiatricke pece
🇨🇿Praha 8, Czechia
Psihiatrijas Centrs
🇱🇻Liepaja, Liepajas Rajons, Latvia
Medical Care and Research S.A. de C.V.
🇲🇽Merida, Yucatan, Mexico
Marienthali Kliinik
🇪🇪Tallinn, Estonia
Riga Centre Of Psychiatry And Addiction Disorders
🇱🇻Riga, Latvia
Sigulda Hospital Outpatient Clinic
🇱🇻Sigulda, Latvia
GUZ Engels Psychiatric Hospital
🇷🇺Engels, Russian Federation
Region Specialized Psychiatric Hospital No.2
🇷🇺Stavropol Region, Kochubeev District, Russian Federation
Arkhangelsk Regional Clinical Mental Hospital
🇷🇺Arkhangelsk, Russian Federation
Moscow Scientific Research Institute of Psychiatry
🇷🇺Moscow, Russian Federation
Clinic named after professor Yu. N. Kasatkin FGBOU DPO RMANPO Minzdrava Rossii
🇷🇺Moscow, Russian Federation
Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...
🇷🇺Nizhny Novgorod, Russian Federation
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
🇷🇺Rostov-on-Don, Russian Federation
LLC Medical Center Nova Vita
🇷🇺Rostov-on-Don, Russian Federation
Hospital OrKli , LLC
🇷🇺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
Psychiatricka ambulancia, MENTUM, s.r.o.
🇸🇰Bratislava, Slovakia
Centro De Salud Mental La Corredoria
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Fundacion Alcorcon
🇪🇸Alcorcon, Madrid, Spain
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Psiquiatric de Palma de Mallorca
🇪🇸Palma de Mallorca, Spain
Smaert & Psykiatricentrum Malmoe
🇸🇪Malmo, Skane, Sweden
Affecta Psyikiatri AB
🇸🇪Halmstad, Sweden
ProbarE i Lund
🇸🇪Lund, Sweden
Communal Non-commercial Enterprise Cherkasy regional psychiatric hospital of Cherkasy regional co...
🇺🇦Smila, Cherkasy, Ukraine
Municipal Non-profit Enterprise Odesa Regional Psychiatric Hospital No.2 of Odesa Regional Council
🇺🇦Kominternivskyy, Odesa, Ukraine
ProbarE
🇸🇪Stockholm, Sweden
Ivano-Frankivsk Oblast neuropsychiatric hospital No. 3
🇺🇦Ivano-Frankivsk, Ukraine
Academy of Medical Sciences of Ukraine - Institute of Neurology, Psychiatry and Narcology
🇺🇦Kharkiv, Ukraine
CI of KRC Regional psychiatric and narcological medical association
🇺🇦Glevakha, 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
Vinnitsa National Medical University
🇺🇦Vinnitsa, Ukraine