<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/NCT01684306</url>
  </required_header>
  <id_info>
    <org_study_id>MODREST_2011</org_study_id>
    <nct_id>NCT01684306</nct_id>
  </id_info>
  <brief_title>Pharmacological Cognitive Enhancement</brief_title>
  <acronym>MODREST</acronym>
  <official_title>Acute Effects of Modafinil on Brain Resting State Networks in Young Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi 'G. d'Annunzio' Chieti e Pescara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi 'G. d'Annunzio' Chieti e Pescara</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is growing debate on the use of drugs that can promote cognitive enhancement.&#xD;
      Amphetamine-like drugs have been employed as cognitive enhancers, but all of them have&#xD;
      important side effects and may induce addiction. In our study, we will investigate the use of&#xD;
      modafinil which, in recent years, has been proposed as cognitive enhancer. Modafinil appears&#xD;
      to have less side effects compared to amphetamine-like drugs and we will analyzed whether the&#xD;
      drug can influence cognitive performances and the brain resting state network activity of&#xD;
      healthy young subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be included in a double-blind, placebo-controlled study in which a single dose&#xD;
      (100 mg) of modafinil will be administered. Both groups will be, before and three hours after&#xD;
      administration of drug or placebo, tested for neuropsychological performances with the&#xD;
      Raven's Advanced Progressive Matrices II set (APM).&#xD;
&#xD;
      Resting state functional magnetic resonance (rs-fMRI) will be also employed, before and after&#xD;
      three hours, to study changes in the activity of resting state brain networks. Finally, with&#xD;
      Diffusion Tensor Imaging (DTI) we will evaluate the structural connectivity of the two&#xD;
      groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">April 2011</primary_completion_date>
  <phase>Early Phase 1</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute effects of modafinil on brain resting state networks in young healthy subjects</measure>
    <time_frame>within one week</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Fluid Inteligence</condition>
  <condition>Modafinil</condition>
  <condition>Healthy Young Subjects</condition>
  <condition>Resting State Networks</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study subjects received, in a double blind fashion, a placebo pill identical to the drug.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modafinil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Modafinil (Provigil), a drug on the market since 1997, is employed for the treatment of narcolepsy and other sleep disorders. In recent years, modafinil has also been used off-label to treat cognitive dysfunction in psychiatric disorders such as schizophrenia and Attention Deficit/Hyperactivity Disorder (ADHD).&#xD;
Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Modafinil</intervention_name>
    <description>Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.</description>
    <arm_group_label>Modafinil</arm_group_label>
    <other_name>Provigil</other_name>
    <other_name>Code name: Modafinil</other_name>
    <other_name>serial number:74507491</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects do not meet the criteria for exclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current signs of psychiatric, neurological or medical (hypertension, cardiac&#xD;
             disorders, epilepsy) conditions as determined by the Millon test and by clinical&#xD;
             examination;subjects showing visual or motor impairments. All subjects taking any&#xD;
             psychoactive drug or having a history of alcohol abuse.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Neuroscience and Imaging, University &quot;G. d'Annunzio&quot;</name>
      <address>
        <city>Chieti</city>
        <zip>66013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 12, 2012</last_update_submitted>
  <last_update_submitted_qc>September 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi 'G. d'Annunzio' Chieti e Pescara</investigator_affiliation>
    <investigator_full_name>Roberto Esposito</investigator_full_name>
    <investigator_title>MD,Phd</investigator_title>
  </responsible_party>
  <keyword>RsfMRI, brain plasticity, cognitive enhancer</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Modafinil</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/NCT01684306
org study id: MODREST_2011
nct id: NCT01684306
lead sponsor: 
has dmc: No
There is growing debate on the use of drugs that can promote cognitive enhancement.
      Amphetamine-like drugs have been employed as cognitive enhancers, but all of them have
      important side effects and may induce addiction. In our study, we will investigate the use of
      modafinil which, in recent years, has been proposed as cognitive enhancer. Modafinil appears
      to have less side effects compared to amphetamine-like drugs and we will analyzed whether the
      drug can influence cognitive performances and the brain resting state network activity of
      healthy young subjects.
Subjects will be included in a double-blind, placebo-controlled study in which a single dose
      (100 mg) of modafinil will be administered. Both groups will be, before and three hours after
      administration of drug or placebo, tested for neuropsychological performances with the
      Raven's Advanced Progressive Matrices II set (APM).

      Resting state functional magnetic resonance (rs-fMRI) will be also employed, before and after
      three hours, to study changes in the activity of resting state brain networks. Finally, with
      Diffusion Tensor Imaging (DTI) we will evaluate the structural connectivity of the two
      groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Acute effects of modafinil on brain resting state networks in young healthy subjects
time frame: within one week
arm group label: Placebo
arm group type: Experimental
description: Study subjects received, in a double blind fashion, a placebo pill identical to the drug.
arm group label: Modafinil
arm group type: Experimental
description: Modafinil (Provigil), a drug on the market since 1997, is employed for the treatment of narcolepsy and other sleep disorders. In recent years, modafinil has also been used off-label to treat cognitive dysfunction in psychiatric disorders such as schizophrenia and Attention Deficit/Hyperactivity Disorder (ADHD).
Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil.
intervention type: Drug
intervention name: Modafinil
description: Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.
arm group label: Modafinil
other name: Provigil
other name: Code name: Modafinil
other name: serial number:74507491
intervention type: Drug
intervention name: Placebo
description: Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.
arm group label: Placebo
criteria: 
gender: Male
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
investigator full name: Roberto Esposito
investigator title: MD,Phd
mesh term: Modafinil