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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04448431
Other study ID # 18498A
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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