<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04448431</url>
  </required_header>
  <id_info>
    <org_study_id>18498A</org_study_id>
    <nct_id>NCT04448431</nct_id>
  </id_info>
  <brief_title>Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression</brief_title>
  <acronym>VIVRE</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lundbeck A/S</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine&#xD;
      after 8 weeks of treatment in patients that have tried one available treatment without&#xD;
      getting the full benefit&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will consist of a screening period of up to 14 days before the Baseline Visit,&#xD;
      followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety&#xD;
      Follow-up Visit will be performed approximately 4 weeks after the Primary Outcome/Withdrawal&#xD;
      Visit.&#xD;
&#xD;
      At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an&#xD;
      8-week, double-blind Treatment Period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">February 4, 2022</completion_date>
  <primary_completion_date type="Actual">January 6, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Remission (defined as a MADRS total score =&lt;10)</measure>
    <time_frame>At Week 8</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response (defined as a =&gt; 50% decrease from baseline in MADRS total score)</measure>
    <time_frame>At Week 8</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MADRS anhedonia factor score</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>(based on items 1(apparent sadness),2 (reported sadness),6 (concentration difficulties),7 (lassitude),8 (inability to feel))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Digital Symbol Substitution Test (DSST) total score</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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 (&lt; normal functioning) to 133 (&gt; normal functioning).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Global Impression - Severity of Illness (CGI-S) score</measure>
    <time_frame>from baseline to Week 8</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression Scale- Global Improvement (CGI-I) score</measure>
    <time_frame>at Day 7,28,56</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functioning Assessment Short Test (FAST) total score</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FAST sub-domain scores</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Q-LES-Q work subscale</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Q-LES-Q household duties subscale</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Q-LES-Q school/course subscale</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Q-LES-Q leisure time activities subscale</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Q-LES-Q social relations subscale</measure>
    <time_frame>From baseline to Week 8</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">605</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Vortioxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 weeks treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Desvenlafaxine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>8 weeks treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vortioxetine</intervention_name>
    <description>10 or 20 mg/day, capsules, orally</description>
    <arm_group_label>Vortioxetine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desvenlafaxine</intervention_name>
    <description>50 mg/day capsules, orally</description>
    <arm_group_label>Desvenlafaxine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to&#xD;
             DSM-5®. The current MDE must be confirmed using the Mini International&#xD;
             Neuropsychiatric Interview (MINI).&#xD;
&#xD;
          -  The patient has a MADRS total score ≥24 at screening and baseline.&#xD;
&#xD;
          -  The patient has had the current MDE for ≥3 months and &lt; 12 months.&#xD;
&#xD;
          -  The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram,&#xD;
             paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE with&#xD;
             a partial response and is a candidate for a switch in the investigator's opinion.&#xD;
&#xD;
          -  The patient wants to switch antidepressant treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has any other disorder for which the treatment takes priority over&#xD;
             treatment of MDD or is likely to interfere with study treatment or impair treatment&#xD;
             compliance.&#xD;
&#xD;
        Other in- and exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Email contact via H. Lundbeck A/S</last_name>
    <role>Study Director</role>
    <affiliation>LundbeckClinicalTrials@Lundbeck.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinica Privada Banfield</name>
      <address>
        <city>Banfield</city>
        <state>Buenos Aires</state>
        <zip>B1828CKR</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cenydet-Centro Neurobiologico Y De Estres Traumatico-Biopsychomedical Research Group Srl</name>
      <address>
        <city>Ciudad Autonoma De Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1058AAJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion para el Estudio y Tratamiento de las enfermedades mentales FETEM</name>
      <address>
        <city>Ciudad Autonoma De Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1133AAH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INAPsi (Instituto Nacional de Psicopatologia)</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1405BOA</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Privada De Salud Mental Santa Teresa De Avila</name>
      <address>
        <city>La Plata</city>
        <state>Buenos Aires</state>
        <zip>1900</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto De Neurociencias San Agustin SA</name>
      <address>
        <city>La Plata</city>
        <state>Buenos Aires</state>
        <zip>B1900BHE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Prof. Leon S. Morra S.A.</name>
      <address>
        <city>Cordoba</city>
        <state>Providencia De Cordo</state>
        <zip>X5009BIN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIAP (Centro de Investigacion y Asistencia en Psiquiatria)</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CINME (Centro de Investigaciones Metabolicas de Buenos Aires)</name>
      <address>
        <city>Ciudad Autonoma De Buenos Aires</city>
        <zip>C1056ABJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEN (Centro Especializado Neurociencias)</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Modelo de Neurologia Fundacion Lennox</name>
      <address>
        <city>Cordoba</city>
        <zip>X5000FAL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Medico DAMIC - Fundacion Rusculleda</name>
      <address>
        <city>Cordoba</city>
        <zip>X5003DCE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro De Asistencia E Investigacion En Neurociencias CENAIN</name>
      <address>
        <city>Mendoza</city>
        <zip>5500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Resolution Psicopharmacology Research Institute</name>
      <address>
        <city>Mendoza</city>
        <zip>M5500BCR</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis St. Lucas-St. Jozef</name>
      <address>
        <city>Brugge</city>
        <zip>8310</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SINAPS - University Antwerpe- Psychiatrisch Ziekenhuis Duffel</name>
      <address>
        <city>Duffel</city>
        <zip>2570</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques De Mont-Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Dr. Hristo Stambolski</name>
      <address>
        <city>Kazanlak</city>
        <zip>6100</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Sv. Ivan Rilski EAD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center For Mental Health-Rousse</name>
      <address>
        <city>Rousse</city>
        <zip>7003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MC Complete Medical Solutions</name>
      <address>
        <city>Samokov</city>
        <zip>2000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Mental Health- Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1202</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Consultative Center Mladost-M Varna OOD</name>
      <address>
        <city>Varna</city>
        <zip>9020</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clintrial s.r.o.</name>
      <address>
        <city>Prague</city>
        <state>Prague 10</state>
        <zip>100 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr.Jan Holan MD, Office of</name>
      <address>
        <city>Brno</city>
        <zip>61500</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum</name>
      <address>
        <city>Havirov</city>
        <zip>73601</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinline services s.r.o.</name>
      <address>
        <city>Hostivice</city>
        <zip>25301</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuropsychiatrie HK, s.r.o.</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>50009</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Mental Health</name>
      <address>
        <city>Klecany</city>
        <zip>25067</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatricka Ambulance</name>
      <address>
        <city>Kutna Hora</city>
        <zip>28401</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A-Shine s.r.o.</name>
      <address>
        <city>Plzen</city>
        <zip>31200</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut neuropsychiatricke pece</name>
      <address>
        <city>Praha 8</city>
        <zip>18600</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marienthali Kliinik</name>
      <address>
        <city>Tallinn</city>
        <zip>11315</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psihiatrijas Centrs</name>
      <address>
        <city>Liepaja</city>
        <state>Liepajas Rajons</state>
        <zip>3401</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga Centre Of Psychiatry And Addiction Disorders</name>
      <address>
        <city>Riga</city>
        <zip>1005</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sigulda Hospital Outpatient Clinic</name>
      <address>
        <city>Sigulda</city>
        <zip>LV-2150</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRI Centro Regiomontano de Investigacion SC</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64060</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Care and Research S.A. de C.V.</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Pharma Professional Research S.A. de C.V.</name>
      <address>
        <city>Ciudad de Mexico</city>
        <zip>03100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Region Specialized Psychiatric Hospital No.2</name>
      <address>
        <city>Stavropol Region</city>
        <state>Kochubeev District</state>
        <zip>357034</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leningrad Regional Psychoneurological Dispensary</name>
      <address>
        <city>Roshchino</city>
        <state>Leningrad Region</state>
        <zip>188820</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkhangelsk Regional Clinical Mental Hospital</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163530</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GUZ Engels Psychiatric Hospital</name>
      <address>
        <city>Engels</city>
        <zip>413124</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Scientific Research Institute of Psychiatry</name>
      <address>
        <city>Moscow</city>
        <zip>107076</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic named after professor Yu. N. Kasatkin FGBOU DPO RMANPO Minzdrava Rossii</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603155</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rostov State Medical University of the Minzdravsotsrazvitiya of Russia</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Medical Center Nova Vita</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344082</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital OrKli , LLC</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>199178</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Astarta</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>199226</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratov State Medical University</name>
      <address>
        <city>Saratov</city>
        <zip>410028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetery Educational Institution Of Higher Professional Education Smolensk State Medical U...</name>
      <address>
        <city>Smolensk</city>
        <zip>214019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Nicolas State Psychiatric Hospital</name>
      <address>
        <city>St. Petersburg</city>
        <zip>190121</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yaroslavl Regional Clinical Psychiatry Hospital</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatricka ambulancia, MENTUM, s.r.o.</name>
      <address>
        <city>Bratislava</city>
        <zip>82007</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epamed, S.R.O</name>
      <address>
        <city>Kosice</city>
        <zip>040 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psycholine S.R.O.</name>
      <address>
        <city>Rimavska Sobota</city>
        <zip>97901</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crystal Comfort, s.r.o.</name>
      <address>
        <city>Vranov Nad Topou</city>
        <zip>09301</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BONA MEDIC s.r.o.</name>
      <address>
        <city>Zlate Moravce</city>
        <zip>95301</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatricka Ambulancia</name>
      <address>
        <city>Zlate Moravce</city>
        <zip>95301</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro De Salud Mental La Corredoria</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Alcorcon</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital De La Santa Creu I Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Psiquiatric de Palma de Mallorca</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smaert &amp; Psykiatricentrum Malmoe</name>
      <address>
        <city>Malmo</city>
        <state>Skane</state>
        <zip>21137</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affecta Psyikiatri AB</name>
      <address>
        <city>Halmstad</city>
        <zip>302 48</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProbarE i Lund</name>
      <address>
        <city>Lund</city>
        <zip>22222</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ONE LIFETIME Lakarmottagning</name>
      <address>
        <city>Skövde</city>
        <zip>541 50</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProbarE</name>
      <address>
        <city>Stockholm</city>
        <zip>11329</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-commercial Enterprise Cherkasy regional psychiatric hospital of Cherkasy regional co...</name>
      <address>
        <city>Smila</city>
        <state>Cherkasy</state>
        <zip>20708</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional clinical psychiatric hosp...</name>
      <address>
        <city>Kharkiv</city>
        <state>Kharkivska</state>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-profit Enterprise Odesa Regional Psychiatric Hospital No.2 of Odesa Regional Council</name>
      <address>
        <city>Kominternivskyy</city>
        <state>Odesa</state>
        <zip>67513</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI of KRC Regional psychiatric and narcological medical association</name>
      <address>
        <city>Glevakha</city>
        <zip>8631</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivano-Frankivsk Oblast neuropsychiatric hospital No. 3</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academy of Medical Sciences of Ukraine - Institute of Neurology, Psychiatry and Narcology</name>
      <address>
        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI INPN Namsu</name>
      <address>
        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv Regional State Clinical Psychiatric Hospital, Lviv Danylo Galytsky National Medical University</name>
      <address>
        <city>Lviv</city>
        <zip>79021</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odessa Regional Medical Centre of Mental Health</name>
      <address>
        <city>Odessa</city>
        <zip>65006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ukrainian Medical Stomatological Academy, Chair Of Psychiatry, Narcology And Medical Psychology B...</name>
      <address>
        <city>Poltava</city>
        <zip>36006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinnitsa National Medical University</name>
      <address>
        <city>Vinnitsa</city>
        <zip>21005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Latvia</country>
    <country>Mexico</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>February 11, 2022</last_update_submitted>
  <last_update_submitted_qc>February 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vortioxetine</mesh_term>
    <mesh_term>Desvenlafaxine Succinate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04448431
org study id: 18498A
nct id: NCT04448431
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
time frame: From baseline to Week 8
description: 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.
measure: Remission (defined as a MADRS total score =<10)
time frame: At Week 8
description: 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.
measure: Response (defined as a => 50% decrease from baseline in MADRS total score)
time frame: At Week 8
description: 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.
measure: Change in MADRS anhedonia factor score
time frame: From baseline to Week 8
description: (based on items 1(apparent sadness),2 (reported sadness),6 (concentration difficulties),7 (lassitude),8 (inability to feel))
measure: Change in Digital Symbol Substitution Test (DSST) total score
time frame: From baseline to Week 8
description: 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).
measure: 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)
time frame: From baseline to Week 8
description: 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.
measure: Change in Clinical Global Impression - Severity of Illness (CGI-S) score
time frame: from baseline to Week 8
description: 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.
measure: Clinical Global Impression Scale- Global Improvement (CGI-I) score
time frame: at Day 7,28,56
description: 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)
measure: Change in Functioning Assessment Short Test (FAST) total score
time frame: From baseline to Week 8
description: 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
measure: Change in FAST sub-domain scores
time frame: From baseline to Week 8
description: 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.
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score
time frame: From baseline to Week 8
description: 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)
measure: Change in Q-LES-Q work subscale
time frame: From baseline to Week 8
description: 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)
measure: Change in Q-LES-Q household duties subscale
time frame: From baseline to Week 8
description: 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)
measure: Change in Q-LES-Q school/course subscale
time frame: From baseline to Week 8
description: 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)
measure: Change in Q-LES-Q leisure time activities subscale
time frame: From baseline to Week 8
description: 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)
measure: Change in Q-LES-Q social relations subscale
time frame: From baseline to Week 8
description: 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)
arm group label: Vortioxetine
arm group type: Experimental
description: 8 weeks treatment
arm group label: Desvenlafaxine
arm group type: Active Comparator
description: 8 weeks treatment
intervention type: Drug
intervention name: Vortioxetine
description: 10 or 20 mg/day, capsules, orally
arm group label: Vortioxetine
intervention type: Drug
intervention name: Desvenlafaxine
description: 50 mg/day capsules, orally
arm group label: Desvenlafaxine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@Lundbeck.com
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country: Argentina
country: Belgium
country: Bulgaria
country: Czechia
country: Estonia
country: Latvia
country: Mexico
country: Russian Federation
country: Slovakia
country: Spain
country: Sweden
country: Ukraine
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Vortioxetine
mesh term: Desvenlafaxine Succinate
sharing ipd: Yes