<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/NCT04410341</url>
  </required_header>
  <id_info>
    <org_study_id>0055/2020</org_study_id>
    <nct_id>NCT04410341</nct_id>
  </id_info>
  <brief_title>The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients</brief_title>
  <official_title>The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sadat City University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sadat City 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4),&#xD;
      increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight&#xD;
      loss and lowering cardiovascular risk. A retrospective longitudinal study by Rizzo et al.&#xD;
      showed that DPP-4 inhibitors administration could have protective effects against cognitive&#xD;
      decline in diabetic elderly. Is has been observed that GLP-1 affects brain metabolism,&#xD;
      increases neuritic growth, and protects neuronal cells from oxidative stress and death.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Effect on Hamilton Depression rating scale score (HAM-D score)</measure>
    <time_frame>12 week</time_frame>
    <description>The principal measure of the outcome was the 17-items HAM-D. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-13 suggest mild depression, 14-17 moderate depression and scores over 17 are indicative of severe depression. Remission is defined as HAM-D total score ≤ 7 (primary outcome). Treatment response is defined as ≥ 50% drop in the HAM-D total score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on biological markers</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>Serum level of tumor necrosis factor alpha (TNF-α)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin-6</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>Serum level of Interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDNF</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>Serum level of Brain derived neurotrophic factor (BDNF)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vildagliptin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escitalopram 20 mg tablet once daily for 12 week plus Vildagliptin 50mg tablet once daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vildagliptin 50 MG</intervention_name>
    <description>Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4), increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight loss and lowering cardiovascular risk.</description>
    <arm_group_label>Vildagliptin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Escitalopram 20 mg</intervention_name>
    <description>Escitalopram,Selective serotonin reuptake inhibitor- Cilostazol, a selective phosphodiesterase 3 (PDE3) inhibitor, acts as an antiplatelet agent and has been widely approved for treatment of intermittent claudication with peripheral arterial disease and for secondary prevention of ischemic stroke.</description>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_label>Vildagliptin group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental&#xD;
             Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview&#xD;
             (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without&#xD;
             psychotic features and a total 17 item HAM-D score of at least 18 with item 1&#xD;
             (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).&#xD;
&#xD;
          -  Patients were requested to be free of all the psychotropic and anti-inflammatory&#xD;
             medications for at least 4 weeks before participating in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with bipolar I or bipolar II disorder&#xD;
&#xD;
          -  Patients with personality disorders&#xD;
&#xD;
          -  Patients with eating disorders&#xD;
&#xD;
          -  Patients with substance dependence or abuse&#xD;
&#xD;
          -  Patients with concurrent active medical condition&#xD;
&#xD;
          -  Patients with history of seizures&#xD;
&#xD;
          -  Patients with history of receiving Electroconvulsive therapy (ECT)&#xD;
&#xD;
          -  Patients with inflammatory disorders&#xD;
&#xD;
          -  Patients with allergy or contraindications to the used medications&#xD;
&#xD;
          -  Patients with finally pregnant or lactating females&#xD;
&#xD;
          -  Cardiovascular disorders&#xD;
&#xD;
          -  Severe renal impairment: creatinine clearance of ≤ 25 ml/min&#xD;
&#xD;
          -  Moderate or severe hepatic impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mahmoud S Abdallah</last_name>
    <phone>00201063340887</phone>
    <email>Mahmoud.samy@fop.usc.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Shibīn Al Kawm</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahmoud S Abdallah, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sadat City University</investigator_affiliation>
    <investigator_full_name>Mahmoud Samy Abdallah</investigator_full_name>
    <investigator_title>Lecturer of Clinical Pharmacy, PhD.</investigator_title>
  </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>Vildagliptin</mesh_term>
    <mesh_term>Escitalopram</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </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/NCT04410341
org study id: 0055/2020
nct id: NCT04410341
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4),
      increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight
      loss and lowering cardiovascular risk. A retrospective longitudinal study by Rizzo et al.
      showed that DPP-4 inhibitors administration could have protective effects against cognitive
      decline in diabetic elderly. Is has been observed that GLP-1 affects brain metabolism,
      increases neuritic growth, and protects neuronal cells from oxidative stress and death.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Effect on Hamilton Depression rating scale score (HAM-D score)
time frame: 12 week
description: The principal measure of the outcome was the 17-items HAM-D. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-13 suggest mild depression, 14-17 moderate depression and scores over 17 are indicative of severe depression. Remission is defined as HAM-D total score ≤ 7 (primary outcome). Treatment response is defined as ≥ 50% drop in the HAM-D total score.
measure: Effect on biological markers
time frame: Baseline and 12 week
description: Serum level of tumor necrosis factor alpha (TNF-α)
measure: Interleukin-6
time frame: Baseline and 12 week
description: Serum level of Interleukin-6 (IL-6)
measure: BDNF
time frame: Baseline and 12 week
description: Serum level of Brain derived neurotrophic factor (BDNF)
arm group label: Placebo group
arm group type: Placebo Comparator
description: Escitalopram 20 mg tablet once daily for 12 week plus placebo tablet once daily for 12 weeks
arm group label: Vildagliptin group
arm group type: Experimental
description: Escitalopram 20 mg tablet once daily for 12 week plus Vildagliptin 50mg tablet once daily for 12 weeks
intervention type: Drug
intervention name: Vildagliptin 50 MG
description: Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4), increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight loss and lowering cardiovascular risk.
arm group label: Vildagliptin group
intervention type: Drug
intervention name: Escitalopram 20 mg
description: Escitalopram,Selective serotonin reuptake inhibitor- Cilostazol, a selective phosphodiesterase 3 (PDE3) inhibitor, acts as an antiplatelet agent and has been widely approved for treatment of intermittent claudication with peripheral arterial disease and for secondary prevention of ischemic stroke.
arm group label: Placebo group
arm group label: Vildagliptin group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mahmoud S Abdallah
phone: 00201063340887
email: Mahmoud.samy@fop.usc.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Sadat City University
investigator full name: Mahmoud Samy Abdallah
investigator title: Lecturer of Clinical Pharmacy, PhD.
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Vildagliptin
mesh term: Escitalopram
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)