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

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT04448431

Collaborator

(none)

605

Enrollment

Locations

Arms

19.6

Actual Duration (Months)

7.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Vortioxetine Drug: Desvenlafaxine	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

605 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 18, 2020

Actual Primary Completion Date :

Jan 6, 2022

Actual Study Completion Date :

Feb 4, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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))
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).
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.
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)
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 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 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 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 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lundbeck A/S

ClinicalTrials.gov Identifier:

NCT04448431

Other Study ID Numbers:

18498A

First Posted:

Jun 25, 2020

Last Update Posted:

Feb 14, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Vortioxetine

Desvenlafaxine Succinate

Study Results

No Results Posted as of Feb 14, 2022