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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
605
10 or 20 mg/day, capsules, orally
50 mg/day capsules, orally
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.
Time frame: From baseline to Week 8
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.
Time frame: At Week 8
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.
Time frame: At Week 8
Change in MADRS anhedonia factor score
(based on items 1(apparent sadness),2 (reported sadness),6 (concentration difficulties),7 (lassitude),8 (inability to feel))
Time frame: From baseline to Week 8
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).
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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
INAPsi (Instituto Nacional de Psicopatologia)
Ciudad Autonoma de Buenos Aires, Buenos Aires, 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
Sanatorio Prof. Leon S. Morra S.A.
Córdoba, Providencia de Cordo, Argentina
CIAP (Centro de Investigacion y Asistencia en Psiquiatria)
Rosario, Santa Fe Province, Argentina
CINME (Centro de Investigaciones Metabolicas de Buenos Aires)
Buenos Aires, Argentina
CEN (Centro Especializado Neurociencias)
Córdoba, Argentina
...and 70 more locations
Time frame: From baseline to Week 8
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.
Time frame: From baseline to Week 8
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.
Time frame: from baseline to Week 8
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)
Time frame: at Day 7,28,56
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
Time frame: From baseline to Week 8
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.
Time frame: From baseline to Week 8
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)
Time frame: From baseline to Week 8
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)
Time frame: From baseline to Week 8
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)
Time frame: From baseline to Week 8
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)
Time frame: From baseline to Week 8
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)
Time frame: From baseline to Week 8
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)
Time frame: From baseline to Week 8