<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/NCT04484558</url>
  </required_header>
  <id_info>
    <org_study_id>01001297992</org_study_id>
    <nct_id>NCT04484558</nct_id>
  </id_info>
  <brief_title>Anxiety and Depression Disorder in Patient Treated With rTPA for Mangment of Acute Ischemic Stroke</brief_title>
  <official_title>Anxiety and Depression Disorder in Patient Treated With rTPA for Mangment of Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      In fact theWorld Health Organization estimates that 2-3% in general populations of countries&#xD;
      across the world tend to be affected by severe mental disorders (1) Thrombolytic therapy&#xD;
      seems to be of great importance in achieving better quality of life in ischemic stroke&#xD;
      patients who respond to this therapy(rTPA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a substantial body of evidenc suggesting a strong relation between neurotrophic&#xD;
      factors and depression and anxiety pathogenesis (2,8) Brain-derived neurotrophic factor&#xD;
      (BDNF), a member of the neurotrophic family known to regulate neuronal plasticity and&#xD;
      survival , may play an important role in the pathophysiology of depression and anxiety (3,9).&#xD;
&#xD;
      Different studies indicated patients who were exposed to traumatic events have anxiety&#xD;
      comorbidity and lower levels of serum BDNF compared to those without a history of traumatic&#xD;
      events (4) .&#xD;
&#xD;
      BDNF has an antidepressant and anxiolytic effect which suggest that BDNF is implicated in the&#xD;
      regulation of anxiety-related behaviors. which leads to a valine-to-methionine change in the&#xD;
      proBDNF protein, was associated with lower activity-dependent secretion of BDNF (5)and has&#xD;
      been implicated with increased susceptibility to neuropsychiatric disorders including&#xD;
      depression, anxiety-related dysfunction, and bipolar disorder , all these studies suggest&#xD;
      that BDNF is likely to be an important etiological factor in memory, depression and anxiety&#xD;
      disorders (6,10).&#xD;
&#xD;
      BDNF arises from a precursor, proBDNF, which is cleaved to produce the mature protein through&#xD;
      the tissue plasminogen activator (tPA) pathway, and represents one mechanism that can&#xD;
      regulate the action of BDNFarises from a precursor, proBDNF, which is cleaved to produce the&#xD;
      mature protein through the tissue plasminogen activator (tPA) pathway, and represents one&#xD;
      mechanism that can regulate the action of BDNF (7).&#xD;
&#xD;
      The purpose of this study is to examine the quality of life after stroke of patients treated&#xD;
      with thrombolysis .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection and measureing anxiety and depressive symptoms in ischemic stroke patients treated with rtpA .</measure>
    <time_frame>15 minutes</time_frame>
    <description>Hamilton depression and anxiety rating scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measuring quality of life in patients with ischemic stroke treated wih rtpA .</measure>
    <time_frame>10 minutes</time_frame>
    <description>Quality of life questionnaire</description>
  </secondary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Acute Stroke</condition>
  <condition>Anxiety Disorders</condition>
  <condition>Depression</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Actilyse</intervention_name>
    <description>Infusion</description>
    <other_name>rTpA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Data will be collected from the clinical interpretation of the patients at presentation and&#xD;
        from the recent patients' medical records which have the full medical histories and&#xD;
        examinations. All patients will be subjected to full neurological history and examination.&#xD;
        The results of the above mentioned laboratory, investigations will be included in future&#xD;
        analysis and interpretation of patients' abnormal neurological findings.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age more than 40.&#xD;
&#xD;
          2. None of the pt had history of other psychiatric illness.&#xD;
&#xD;
          3. male and female.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1-smoker. 2-substance abuser or dependence. 3-History of other psychiatric illness.&#xD;
             4-History of other neurological illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Ebtsam Mohamed Tawfik</last_name>
    <phone>+0201001297992</phone>
    <email>ebtsamtawfik393@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>17111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ebtsam MM Tawfik, M.D.</last_name>
      <phone>01001297992</phone>
      <email>Ebtsamtawfik393@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Musumeci G, Sciarretta C, Rodriguez-Moreno A, Al Banchaabouchi M, Negrete-Diaz V, Costanzi M, Berno V, Egorov AV, von Bohlen Und Halbach O, Cestari V, Delgado-Garcia JM, Minichiello L. TrkB modulates fear learning and amygdalar synaptic plasticity by specific docking sites. J Neurosci. 2009 Aug 12;29(32):10131-43. doi: 10.1523/JNEUROSCI.1707-09.2009.</citation>
    <PMID>19675247</PMID>
  </reference>
  <reference>
    <citation>Noble EE, Billington CJ, Kotz CM, Wang C. The lighter side of BDNF. Am J Physiol Regul Integr Comp Physiol. 2011 May;300(5):R1053-69. doi: 10.1152/ajpregu.00776.2010. Epub 2011 Feb 23.</citation>
    <PMID>21346243</PMID>
  </reference>
  <reference>
    <citation>Kauer-Sant'Anna M, Tramontina J, Andreazza AC, Cereser K, da Costa S, Santin A, Yatham LN, Kapczinski F. Traumatic life events in bipolar disorder: impact on BDNF levels and psychopathology. Bipolar Disord. 2007 Jun;9 Suppl 1:128-35. doi: 10.1111/j.1399-5618.2007.00478.x.</citation>
    <PMID>17543031</PMID>
  </reference>
  <results_reference>
    <citation>Li Y, Luikart BW, Birnbaum S, Chen J, Kwon CH, Kernie SG, Bassel-Duby R, Parada LF. TrkB regulates hippocampal neurogenesis and governs sensitivity to antidepressive treatment. Neuron. 2008 Aug 14;59(3):399-412. doi: 10.1016/j.neuron.2008.06.023. Erratum In: Neuron. 2008 Nov 26;60(4):730.</citation>
    <PMID>18701066</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>February 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ebtsam Tawfik</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Plasminogen Activator</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04484558
org study id: 01001297992
nct id: NCT04484558
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
In fact theWorld Health Organization estimates that 2-3% in general populations of countries
      across the world tend to be affected by severe mental disorders (1) Thrombolytic therapy
      seems to be of great importance in achieving better quality of life in ischemic stroke
      patients who respond to this therapy(rTPA).
There is a substantial body of evidenc suggesting a strong relation between neurotrophic
      factors and depression and anxiety pathogenesis (2,8) Brain-derived neurotrophic factor
      (BDNF), a member of the neurotrophic family known to regulate neuronal plasticity and
      survival , may play an important role in the pathophysiology of depression and anxiety (3,9).

      Different studies indicated patients who were exposed to traumatic events have anxiety
      comorbidity and lower levels of serum BDNF compared to those without a history of traumatic
      events (4) .

      BDNF has an antidepressant and anxiolytic effect which suggest that BDNF is implicated in the
      regulation of anxiety-related behaviors. which leads to a valine-to-methionine change in the
      proBDNF protein, was associated with lower activity-dependent secretion of BDNF (5)and has
      been implicated with increased susceptibility to neuropsychiatric disorders including
      depression, anxiety-related dysfunction, and bipolar disorder , all these studies suggest
      that BDNF is likely to be an important etiological factor in memory, depression and anxiety
      disorders (6,10).

      BDNF arises from a precursor, proBDNF, which is cleaved to produce the mature protein through
      the tissue plasminogen activator (tPA) pathway, and represents one mechanism that can
      regulate the action of BDNFarises from a precursor, proBDNF, which is cleaved to produce the
      mature protein through the tissue plasminogen activator (tPA) pathway, and represents one
      mechanism that can regulate the action of BDNF (7).

      The purpose of this study is to examine the quality of life after stroke of patients treated
      with thrombolysis .
observational model: Case-Only
time perspective: Cross-Sectional
measure: Detection and measureing anxiety and depressive symptoms in ischemic stroke patients treated with rtpA .
time frame: 15 minutes
description: Hamilton depression and anxiety rating scale
measure: Measuring quality of life in patients with ischemic stroke treated wih rtpA .
time frame: 10 minutes
description: Quality of life questionnaire
intervention type: Drug
intervention name: Actilyse
description: Infusion
other name: rTpA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
last name: Ebtsam Mohamed Tawfik
phone: +0201001297992
email: ebtsamtawfik393@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Musumeci G, Sciarretta C, Rodriguez-Moreno A, Al Banchaabouchi M, Negrete-Diaz V, Costanzi M, Berno V, Egorov AV, von Bohlen Und Halbach O, Cestari V, Delgado-Garcia JM, Minichiello L. TrkB modulates fear learning and amygdalar synaptic plasticity by specific docking sites. J Neurosci. 2009 Aug 12;29(32):10131-43. doi: 10.1523/JNEUROSCI.1707-09.2009.
PMID: 19675247
citation: Noble EE, Billington CJ, Kotz CM, Wang C. The lighter side of BDNF. Am J Physiol Regul Integr Comp Physiol. 2011 May;300(5):R1053-69. doi: 10.1152/ajpregu.00776.2010. Epub 2011 Feb 23.
PMID: 21346243
citation: Kauer-Sant'Anna M, Tramontina J, Andreazza AC, Cereser K, da Costa S, Santin A, Yatham LN, Kapczinski F. Traumatic life events in bipolar disorder: impact on BDNF levels and psychopathology. Bipolar Disord. 2007 Jun;9 Suppl 1:128-35. doi: 10.1111/j.1399-5618.2007.00478.x.
PMID: 17543031
citation: Li Y, Luikart BW, Birnbaum S, Chen J, Kwon CH, Kernie SG, Bassel-Duby R, Parada LF. TrkB regulates hippocampal neurogenesis and governs sensitivity to antidepressive treatment. Neuron. 2008 Aug 14;59(3):399-412. doi: 10.1016/j.neuron.2008.06.023. Erratum In: Neuron. 2008 Nov 26;60(4):730.
PMID: 18701066
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ebtsam Tawfik
investigator title: Principal investigator
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
mesh term: Tissue Plasminogen Activator