<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/NCT02187835</url>
  </required_header>
  <id_info>
    <org_study_id>GHS001</org_study_id>
    <nct_id>NCT02187835</nct_id>
  </id_info>
  <brief_title>Decreased EEG Complexity in Schizophrenia</brief_title>
  <official_title>Decreased EEG Complexity in Chronic Residual Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uskudar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uskudar University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim was to detect EEG complexity in a specific group of patients to contribute to the&#xD;
      discussion whether schizophrenia is associated with increased or decreased complexity. We&#xD;
      included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized&#xD;
      that chronic residual schizophrenia is characterized by decreased complexity in EEG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty right-handed patients diagnosed with schizophrenia, residual subtype, by two senior&#xD;
      psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition&#xD;
      (DSM-IV)were recruited from Neuropsychiatry Istanbul Hospital. Only patients scoring 4 or&#xD;
      higher on the Clinical Global Impression Scale for Severity (CGI-S) were included. They were&#xD;
      assessed with the Turkish version of the Positive and Negative Syndrome Scale. Data was&#xD;
      collected with a 16-channel Neuroscan Synamps II (Neuroscan Products, Compumedics, Charlotte,&#xD;
      NC, USA), silver-silver chloride electrodes were applied to the scalp surface according to&#xD;
      the international 10-20 system&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the mean of the average Logarithmic Energy Entropy values</measure>
    <time_frame>one day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hurst Exponent value</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Electrophysiological Randomness</condition>
  <condition>Entropy</condition>
  <arm_group>
    <arm_group_label>schizophrenia</arm_group_label>
    <description>patients with a diagnosis of schizohrenia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>healthy control group</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        diagnosed with schizophrenia,&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to&#xD;
        the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV) were recruited&#xD;
        from Neuropsychiatry Istanbul Hospital Only patients scoring 4 or higher on the Clinical&#xD;
        Global Impression Scale for Severity (CGI-S)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Uskudar University, NPIstanbul hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Umraniye</state>
        <zip>34768</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://www.npistanbul.com</url>
    <description>Neuropsychiatry Istanbul Hospital, Istanbul, Turkey</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uskudar University</investigator_affiliation>
    <investigator_full_name>Gokben Hizli Sayar</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>complexity</keyword>
  <keyword>electroencephalogram</keyword>
  <keyword>entropy</keyword>
  <keyword>negative symptoms</keyword>
  <keyword>schizophrenia.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>July 10, 2014</submitted>
    <returned>August 4, 2014</returned>
  </pending_results>
  <!-- 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/NCT02187835
org study id: GHS001
nct id: NCT02187835
lead sponsor: 
has dmc: No
Aim was to detect EEG complexity in a specific group of patients to contribute to the
      discussion whether schizophrenia is associated with increased or decreased complexity. We
      included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized
      that chronic residual schizophrenia is characterized by decreased complexity in EEG.
Twenty right-handed patients diagnosed with schizophrenia, residual subtype, by two senior
      psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition
      (DSM-IV)were recruited from Neuropsychiatry Istanbul Hospital. Only patients scoring 4 or
      higher on the Clinical Global Impression Scale for Severity (CGI-S) were included. They were
      assessed with the Turkish version of the Positive and Negative Syndrome Scale. Data was
      collected with a 16-channel Neuroscan Synamps II (Neuroscan Products, Compumedics, Charlotte,
      NC, USA), silver-silver chloride electrodes were applied to the scalp surface according to
      the international 10-20 system
observational model: Case-Control
time perspective: Retrospective
measure: the mean of the average Logarithmic Energy Entropy values
time frame: one day
measure: Hurst Exponent value
time frame: one day
arm group label: schizophrenia
description: patients with a diagnosis of schizohrenia
arm group label: control
description: healthy control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
url: http://www.npistanbul.com
description: Neuropsychiatry Istanbul Hospital, Istanbul, Turkey
responsible party type: Principal Investigator
investigator affiliation: Uskudar University
investigator full name: Gokben Hizli Sayar
investigator title: M.D.
mesh term: Schizophrenia
submitted: July 10, 2014
returned: August 4, 2014