xml: <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/NCT06025474</url>
    </required_header>
    <id_info>
      <org_study_id>251/19</org_study_id>
      <nct_id>NCT06025474</nct_id>
    </id_info>
    <brief_title>Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome</brief_title>
    <official_title>Comparative Evaluation of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Treatment-resistant Burning Mouth Syndrome: a Prospective Longitudinal Clinical Trial With Treatment Response Prediction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Federico II University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Federico II University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: The treatment of Burning Mouth Syndrome (BMS) presents a challenge in tailoring&#xD;
        appropriate medication for individual patients. Antidepressants have demonstrated efficacy in&#xD;
        alleviating symptoms in most cases; however, a subset of patients exhibit limited or no&#xD;
        response to these treatments. The augmentation with pregabalin to conventional treatment has&#xD;
        shown promising outcomes in relieving pain and improving quality of life in chronic pain&#xD;
        conditions. This study aimed to compare the efficacy of vortioxetine with other&#xD;
        antidepressants (SSRIs/SNRIs) in combination with pregabalin in a cohort of unresponsive BMS&#xD;
        patients and to predict treatment response using clinical data.&#xD;
  &#xD;
        Methods: A 52-week randomized, open-label, active-controlled study was conducted, enrolling&#xD;
        203 BMS patients previously treated with one antidepressant for 12 weeks and non-responder to&#xD;
        the treatment. The study sample have included two groups: Group A (136) received&#xD;
        vortioxetine, while Group B (67) received SSRIs/SNRIs. Pregabalin (75mg/day) was added to&#xD;
        both groups, with a potential dosage increase to 150mg/day for inadequate responders after 12&#xD;
        weeks.&#xD;
  &#xD;
        Treatment response was assessed by measuring reduction in VAS and SF-MPQ scores (&gt;50 or 1-2)&#xD;
        and HAM-A and HAM-D scores (&gt;50% or ≤7) at 12, 24, 36 and 52 weeks. Classical logistic&#xD;
        regression with a stepwise algorithm and Random Forest machine learning models were used to&#xD;
        predict treatment response.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">July 24, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <phase>Phase 3</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale (VAS)</measure>
      <time_frame>4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks</time_frame>
      <description>The Visual Analog Scale (VAS) (Hayes and Patterson, 1921) is a well-validated unidimensional instrument for the measure of pain intensity (Hawker et al., 2011). The score is determined by measuring the distance on the line between the &quot;no pain&quot; and the mark of a patient mark, providing a range of scores from 0 to 10 (0 = no oral symptoms and 10 = the worst imaginable discomfort).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short-form McGill Pain Questionnaire (SF-MPQ)</measure>
      <time_frame>4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks</time_frame>
      <description>the short form of the McGill Pain Questionnaire (SF-MPQ) is a measure of the quality of pain and is a multidimensional pain questionnaire, which measures the sensory, affective, and evaluative aspects of the perceived pain (Hawker et al., 2011). It comprises 15 items from the original MPQ, each scored from 0 (none) to 3 (severe). The SF-MPQ score is obtained by summing the item scores (range 0-45). There are no established critical cutoff points for the interpretation of the scores and, as for the MPQ, a higher score indicates the worse pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hamilton rating scale for Depression (HAM-D)</measure>
      <time_frame>4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks</time_frame>
      <description>The HAM-D is a clinician-administered depression assessment scale; it contains 21 items pertaining to the affective field. The scores can range from 0 to 54. A score &gt; 7 indicates an impairment. The scores in the range of 7-17 indicate a mild depression, the scores between 18 and 24 indicate a moderate depression, and the scores &gt;24 indicate a severe depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton rating scale for Anxiety (HAM-A)</measure>
      <time_frame>4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks</time_frame>
      <description>The HAM-A (Hamilton, 1959) is a clinician-administered anxiety assessment scale. It comprises 14 items to measure both psychic anxiety and somatic anxiety. Each item is scored on a scale of 0-4, a total score &lt;17 indicates a mild severity, 18-24 mild to moderate, and 25-30 moderate to severe (Hamilton, 1967).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks</time_frame>
      <description>The PSQI (Buysse et al., 1989) explores the quality of sleep over a 1-month time interval generating seven &quot;component&quot; scores (0-3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction (Carpenter and Andrykowski, 1998). The total score is obtained by the sum of all the sub-scores and ranges between 0 and 21. A total score greater than five discriminates poor sleepers from good sleepers with a high sensitivity (90%-99%) and specificity (84%-87%) (Curcio et al., 2013).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Clinical Global Impression Scale - Improvement (CGI-I) and Severity (CGI-S)</measure>
      <time_frame>3 times evaluation: time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks</time_frame>
      <description>CGI-I scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.</description>
    </other_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">203</enrollment>
    <condition>Burning Mouth Syndrome</condition>
    <arm_group>
      <arm_group_label>Vortioxetine+Pregabalin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>VO group(20mg)+ PGB (75mg) N= 136 Vortioxetine 20 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Paroxetine+Pregabalin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>P group (20mg) + PGB (75mg); N= 10 Paroxetine 20 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sertraline+Pregabalin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>S group (50mg) + PGB (75mg); N= 8 Sertraline 50 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Citalopram+Pregabalin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>C group (20mg)+ PGB (75mg) N= 8 Citalopram 20 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Escitalopram+Pregabalin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>E group (10mg) + PGB (75mg); N= 8 Escitalopram 10 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Duloxetine+Pregabalin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>D group (60mg)+ PGB (75mg) N= 33 Duloxetine 60 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vortioxetine 20Mg Tab</intervention_name>
      <description>Encapsulated vortioxetine immediate release tablets, once daily</description>
      <arm_group_label>Vortioxetine+Pregabalin</arm_group_label>
      <other_name>Brintellix</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Paroxetine 20 Mg Oral Tablet</intervention_name>
      <description>Encapsulated paroxetine tablets, once daily</description>
      <arm_group_label>Paroxetine+Pregabalin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sertraline 50 MG</intervention_name>
      <description>Encapsulated sertraline tablets, once daily</description>
      <arm_group_label>Sertraline+Pregabalin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Citalopram 20mg</intervention_name>
      <description>Encapsulated citalopram tablets, once daily</description>
      <arm_group_label>Citalopram+Pregabalin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Escitalopram 10mg</intervention_name>
      <description>Encapsulated escitalopram tablets, once daily</description>
      <arm_group_label>Escitalopram+Pregabalin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Duloxetine 60 MG</intervention_name>
      <description>Encapsulated duloxetine tablets, once daily</description>
      <arm_group_label>Duloxetine+Pregabalin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pregabalin 75mg</intervention_name>
      <description>Encapsulated pregabalin tablets, once daily</description>
      <arm_group_label>Citalopram+Pregabalin</arm_group_label>
      <arm_group_label>Duloxetine+Pregabalin</arm_group_label>
      <arm_group_label>Escitalopram+Pregabalin</arm_group_label>
      <arm_group_label>Paroxetine+Pregabalin</arm_group_label>
      <arm_group_label>Sertraline+Pregabalin</arm_group_label>
      <arm_group_label>Vortioxetine+Pregabalin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with a confirmed diagnosis of BMS based on the International Classification&#xD;
               of Orofacial Pain, 1st edition [International Classification of Orofacial Pain, 1st&#xD;
               edition (ICOP) Cephalalgia, 2020]&#xD;
  &#xD;
            -  patients of any race or gender; complaining of oral burning recurring daily for &gt;2 h&#xD;
               per day for &gt;3 months;&#xD;
  &#xD;
            -  normal blood test findings (including blood count, blood glucose levels, glycated&#xD;
               hemoglobin, serum iron, ferritin and transferrin).&#xD;
  &#xD;
            -  BMS patients previously treated with one antidepressant for 12 weeks and non-responder&#xD;
               to the treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  the presence of any disease that could be recognized as a causative factor of BMS,&#xD;
  &#xD;
            -  a history of a psychiatric disorder or a neurological or organic brain disorder,&#xD;
  &#xD;
            -  a history of alcohol or substance abuse,&#xD;
  &#xD;
            -  the presence of Obstructive Sleep Apnea Syndrome (OSAS)&#xD;
  &#xD;
            -  uncontrolled hypertension, diabetes, HIV, narrow-angle glaucoma, or participants&#xD;
               enrolled in other investigational studies.&#xD;
  &#xD;
            -  participants requiring continued treatment with medications that adversely interact&#xD;
               with the study medications (eg, quinolone antibiotics, warfarin, agents inhibiting&#xD;
               serotonin reuptake) or with hereditary problems of fructose intolerance, glucose&#xD;
               galactose malabsorption, or sucrose isomaltase insufficiency&#xD;
  &#xD;
            -  pregnancy and lactation were exclusion criteria, and women of childbearing potential&#xD;
               were required to receive a highly effective form of contraception.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Daniela Adamo</last_name>
      <phone>+39 3925253864</phone>
      <email>danielaadamo.it@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Naples Federico II</name>
        <address>
          <city>Napoli</city>
          <state>Italia</state>
          <zip>80131</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniela Adamo</last_name>
        <phone>+39 3925253864</phone>
        <email>danielaadamo.it@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <reference>
      <citation>Adamo D, Calabria E, Coppola N, Pecoraro G, Mignogna MD. Vortioxetine as a new frontier in the treatment of chronic neuropathic pain: a review and update. Ther Adv Psychopharmacol. 2021 Sep 3;11:20451253211034320. doi: 10.1177/20451253211034320. eCollection 2021.</citation>
      <PMID>34497709</PMID>
    </reference>
    <reference>
      <citation>Adamo D, Pecoraro G, Coppola N, Calabria E, Aria M, Mignogna M. Vortioxetine versus other antidepressants in the treatment of burning mouth syndrome: An open-label randomized trial. Oral Dis. 2021 May;27(4):1022-1041. doi: 10.1111/odi.13602. Epub 2020 Sep 15.</citation>
      <PMID>32790904</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Federico II University</investigator_affiliation>
      <investigator_full_name>Daniela Adamo</investigator_full_name>
      <investigator_title>Clinical Assistant</investigator_title>
    </responsible_party>
    <keyword>Burning mouth syndrome</keyword>
    <keyword>vortioxetine</keyword>
    <keyword>pregabalin</keyword>
    <keyword>Drug Therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Burning Mouth Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Burns</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pregabalin</mesh_term>
      <mesh_term>Duloxetine Hydrochloride</mesh_term>
      <mesh_term>Vortioxetine</mesh_term>
      <mesh_term>Citalopram</mesh_term>
      <mesh_term>Sertraline</mesh_term>
      <mesh_term>Paroxetine</mesh_term>
      <mesh_term>Escitalopram</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025474
  org study id: 251/19
  nct id: NCT06025474
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Background: The treatment of Burning Mouth Syndrome (BMS) presents a challenge in tailoring
        appropriate medication for individual patients. Antidepressants have demonstrated efficacy in
        alleviating symptoms in most cases; however, a subset of patients exhibit limited or no
        response to these treatments. The augmentation with pregabalin to conventional treatment has
        shown promising outcomes in relieving pain and improving quality of life in chronic pain
        conditions. This study aimed to compare the efficacy of vortioxetine with other
        antidepressants (SSRIs/SNRIs) in combination with pregabalin in a cohort of unresponsive BMS
        patients and to predict treatment response using clinical data.
  
        Methods: A 52-week randomized, open-label, active-controlled study was conducted, enrolling
        203 BMS patients previously treated with one antidepressant for 12 weeks and non-responder to
        the treatment. The study sample have included two groups: Group A (136) received
        vortioxetine, while Group B (67) received SSRIs/SNRIs. Pregabalin (75mg/day) was added to
        both groups, with a potential dosage increase to 150mg/day for inadequate responders after 12
        weeks.
  
        Treatment response was assessed by measuring reduction in VAS and SF-MPQ scores (>50 or 1-2)
        and HAM-A and HAM-D scores (>50% or ≤7) at 12, 24, 36 and 52 weeks. Classical logistic
        regression with a stepwise algorithm and Random Forest machine learning models were used to
        predict treatment response.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Visual Analog Scale (VAS)
  time frame: 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
  description: The Visual Analog Scale (VAS) (Hayes and Patterson, 1921) is a well-validated unidimensional instrument for the measure of pain intensity (Hawker et al., 2011). The score is determined by measuring the distance on the line between the "no pain" and the mark of a patient mark, providing a range of scores from 0 to 10 (0 = no oral symptoms and 10 = the worst imaginable discomfort).
  measure: Short-form McGill Pain Questionnaire (SF-MPQ)
  time frame: 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
  description: the short form of the McGill Pain Questionnaire (SF-MPQ) is a measure of the quality of pain and is a multidimensional pain questionnaire, which measures the sensory, affective, and evaluative aspects of the perceived pain (Hawker et al., 2011). It comprises 15 items from the original MPQ, each scored from 0 (none) to 3 (severe). The SF-MPQ score is obtained by summing the item scores (range 0-45). There are no established critical cutoff points for the interpretation of the scores and, as for the MPQ, a higher score indicates the worse pain.
  measure: Hamilton rating scale for Depression (HAM-D)
  time frame: 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
  description: The HAM-D is a clinician-administered depression assessment scale; it contains 21 items pertaining to the affective field. The scores can range from 0 to 54. A score > 7 indicates an impairment. The scores in the range of 7-17 indicate a mild depression, the scores between 18 and 24 indicate a moderate depression, and the scores >24 indicate a severe depression
  measure: Hamilton rating scale for Anxiety (HAM-A)
  time frame: 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
  description: The HAM-A (Hamilton, 1959) is a clinician-administered anxiety assessment scale. It comprises 14 items to measure both psychic anxiety and somatic anxiety. Each item is scored on a scale of 0-4, a total score <17 indicates a mild severity, 18-24 mild to moderate, and 25-30 moderate to severe (Hamilton, 1967).
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: 4 times evaluation: time 0: 0 week; time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
  description: The PSQI (Buysse et al., 1989) explores the quality of sleep over a 1-month time interval generating seven "component" scores (0-3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction (Carpenter and Andrykowski, 1998). The total score is obtained by the sum of all the sub-scores and ranges between 0 and 21. A total score greater than five discriminates poor sleepers from good sleepers with a high sensitivity (90%-99%) and specificity (84%-87%) (Curcio et al., 2013).
  measure: Clinical Global Impression Scale - Improvement (CGI-I) and Severity (CGI-S)
  time frame: 3 times evaluation: time 1: 12 weeks; time 2: 24 weeks; time 3: 36 weeks; time 4: 52 weeks
  description: CGI-I scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.
  arm group label: Vortioxetine+Pregabalin
  arm group type: Experimental
  description: VO group(20mg)+ PGB (75mg) N= 136 Vortioxetine 20 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks
  arm group label: Paroxetine+Pregabalin
  arm group type: Active Comparator
  description: P group (20mg) + PGB (75mg); N= 10 Paroxetine 20 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks
  arm group label: Sertraline+Pregabalin
  arm group type: Active Comparator
  description: S group (50mg) + PGB (75mg); N= 8 Sertraline 50 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks
  arm group label: Citalopram+Pregabalin
  arm group type: Active Comparator
  description: C group (20mg)+ PGB (75mg) N= 8 Citalopram 20 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks
  arm group label: Escitalopram+Pregabalin
  arm group type: Active Comparator
  description: E group (10mg) + PGB (75mg); N= 8 Escitalopram 10 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks
  arm group label: Duloxetine+Pregabalin
  arm group type: Active Comparator
  description: D group (60mg)+ PGB (75mg) N= 33 Duloxetine 60 mg, encapsulated tablets, orally, once daily, then pregabalin 75 mg, encapsulated tablets, orally, once daily. Pregabalin (75mg/day) was added, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks
  intervention type: Drug
  intervention name: Vortioxetine 20Mg Tab
  description: Encapsulated vortioxetine immediate release tablets, once daily
  arm group label: Vortioxetine+Pregabalin
  other name: Brintellix
  intervention type: Drug
  intervention name: Paroxetine 20 Mg Oral Tablet
  description: Encapsulated paroxetine tablets, once daily
  arm group label: Paroxetine+Pregabalin
  intervention type: Drug
  intervention name: Sertraline 50 MG
  description: Encapsulated sertraline tablets, once daily
  arm group label: Sertraline+Pregabalin
  intervention type: Drug
  intervention name: Citalopram 20mg
  description: Encapsulated citalopram tablets, once daily
  arm group label: Citalopram+Pregabalin
  intervention type: Drug
  intervention name: Escitalopram 10mg
  description: Encapsulated escitalopram tablets, once daily
  arm group label: Escitalopram+Pregabalin
  intervention type: Drug
  intervention name: Duloxetine 60 MG
  description: Encapsulated duloxetine tablets, once daily
  arm group label: Duloxetine+Pregabalin
  intervention type: Drug
  intervention name: Pregabalin 75mg
  description: Encapsulated pregabalin tablets, once daily
  arm group label: Citalopram+Pregabalin
  arm group label: Duloxetine+Pregabalin
  arm group label: Escitalopram+Pregabalin
  arm group label: Paroxetine+Pregabalin
  arm group label: Sertraline+Pregabalin
  arm group label: Vortioxetine+Pregabalin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Daniela Adamo
  phone: +39 3925253864
  email: danielaadamo.it@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  citation: Adamo D, Calabria E, Coppola N, Pecoraro G, Mignogna MD. Vortioxetine as a new frontier in the treatment of chronic neuropathic pain: a review and update. Ther Adv Psychopharmacol. 2021 Sep 3;11:20451253211034320. doi: 10.1177/20451253211034320. eCollection 2021.
  PMID: 34497709
  citation: Adamo D, Pecoraro G, Coppola N, Calabria E, Aria M, Mignogna M. Vortioxetine versus other antidepressants in the treatment of burning mouth syndrome: An open-label randomized trial. Oral Dis. 2021 May;27(4):1022-1041. doi: 10.1111/odi.13602. Epub 2020 Sep 15.
  PMID: 32790904
  responsible party type: Principal Investigator
  investigator affiliation: Federico II University
  investigator full name: Daniela Adamo
  investigator title: Clinical Assistant
  mesh term: Burning Mouth Syndrome
  mesh term: Syndrome
  mesh term: Burns
  mesh term: Pregabalin
  mesh term: Duloxetine Hydrochloride
  mesh term: Vortioxetine
  mesh term: Citalopram
  mesh term: Sertraline
  mesh term: Paroxetine
  mesh term: Escitalopram