<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/NCT04414930</url>
  </required_header>
  <id_info>
    <org_study_id>R33MH123603-01</org_study_id>
    <nct_id>NCT04414930</nct_id>
  </id_info>
  <brief_title>Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia</brief_title>
  <official_title>Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <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>
      These studies look to conduct efficient pilot testing of a novel intervention strategy for&#xD;
      chronic psychotic disorders - Pharmacologic Augmentation of Cognitive Therapy (PACT) - via an&#xD;
      experimental medicine approach. Antipsychotics are the major therapeutic tool for chronic&#xD;
      psychotic disorders, including schizophrenia, but do not significantly alter their course or&#xD;
      real-life impact. Specific cognitive therapies achieve modest symptom reduction and improved&#xD;
      function and cognition in psychosis patients, including &quot;bottom-up&quot; sensory-based targeted&#xD;
      cognitive training (TCT). While benefits of TCT are evident at the group level, almost half&#xD;
      of all patients demonstrate little or no cognitive gains after 30-40 hours (h) of TCT. For&#xD;
      patients and clinicians, the costs and logistical complexities associated with these time-&#xD;
      and resource-intensive interventions can be prohibitive. We propose and will test a novel&#xD;
      &quot;augmentation strategy&quot; for using medications to specifically enhance the benefits of TCT in&#xD;
      schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 9, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline TCT weekly for 30 weeks, plus 2 post session tests</measure>
    <time_frame>screening session (week 1) followed by weekly sessions for 10 weeks, 3 times per week (weeks 2- ~12), and 2 post session tests after week 12 and after week 22</time_frame>
    <description>Sound Sweeps</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>TCT + PBO</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>TCT + AMPH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMPH</intervention_name>
    <description>Suppressing active psychosis with antipsychotics benefits cognitive interventions for schizophrenia, but it is possible that drugs with pro-cognitive effects will specifically, and perhaps synergistically, augment the clinical benefits of cognitive therapies. A &quot;proof of concept&quot; for this approach is found in the use of the pro-extinction drugs to selectively enhance the impact of cognitive therapy for anxiety disorders. In this &quot;proof of concept&quot;, a learning-based therapy is paired with a medication that enhances a brain mechanism (extinction) that is both 1) critical to that form of learning, and 2) known to be deficient in some anxiety disorders.</description>
    <arm_group_label>TCT + AMPH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHAM</intervention_name>
    <description>Suppressing active psychosis with antipsychotics benefits cognitive interventions for schizophrenia, but it is possible that drugs with pro-cognitive effects will specifically, and perhaps synergistically, augment the clinical benefits of cognitive therapies. A &quot;proof of concept&quot; for this approach is found in the use of the pro-extinction drugs to selectively enhance the impact of cognitive therapy for anxiety disorders. In this &quot;proof of concept&quot;, a learning-based therapy is paired with a medication that enhances a brain mechanism (extinction) that is both 1) critical to that form of learning, and 2) known to be deficient in some anxiety disorders.</description>
    <arm_group_label>TCT + PBO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria include:&#xD;
&#xD;
          -  DSM-IV diagnosis of schizophrenia or schizoaffective disorder, depressed type&#xD;
&#xD;
          -  Written informed consent to participate in the study&#xD;
&#xD;
          -  Age 18 - 55&#xD;
&#xD;
          -  Absence of dementia or mental retardation&#xD;
&#xD;
          -  Urine toxicology negative for recreational drugs&#xD;
&#xD;
          -  Fluent and literate in English (needed for completion of WIN and QuickSIN)&#xD;
&#xD;
        Exclusion criteria include:&#xD;
&#xD;
          -  Meets DSM-IV criteria for current substance abuse or dependence and has been substance&#xD;
             abstinent for less than 30 days&#xD;
&#xD;
          -  A history of traumatic brain injury&#xD;
&#xD;
          -  Auditory or visual impairments severe enough to prevent study participation&#xD;
&#xD;
          -  Under conservatorship (determined by Anasazi)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neal R Serdlow, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC San Diego</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jo Benrubi, B.A.</last_name>
    <phone>6195432314</phone>
    <email>eyeblinkstudy@ucsd.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinical Teaching Facility (CTF-B102) at UCSD Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jo Talledo Benrubi, B.A.</last_name>
      <phone>619-543-3093</phone>
      <email>atalledo@ucsd.edu</email>
    </contact>
    <investigator>
      <last_name>Neal R. Swerdlow, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Neal R. Swerdlow, M.D., Ph.D.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_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/NCT04414930
org study id: R33MH123603-01
nct id: NCT04414930
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
These studies look to conduct efficient pilot testing of a novel intervention strategy for
      chronic psychotic disorders - Pharmacologic Augmentation of Cognitive Therapy (PACT) - via an
      experimental medicine approach. Antipsychotics are the major therapeutic tool for chronic
      psychotic disorders, including schizophrenia, but do not significantly alter their course or
      real-life impact. Specific cognitive therapies achieve modest symptom reduction and improved
      function and cognition in psychosis patients, including "bottom-up" sensory-based targeted
      cognitive training (TCT). While benefits of TCT are evident at the group level, almost half
      of all patients demonstrate little or no cognitive gains after 30-40 hours (h) of TCT. For
      patients and clinicians, the costs and logistical complexities associated with these time-
      and resource-intensive interventions can be prohibitive. We propose and will test a novel
      "augmentation strategy" for using medications to specifically enhance the benefits of TCT in
      schizophrenia.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from baseline TCT weekly for 30 weeks, plus 2 post session tests
time frame: screening session (week 1) followed by weekly sessions for 10 weeks, 3 times per week (weeks 2- ~12), and 2 post session tests after week 12 and after week 22
description: Sound Sweeps
arm group label: TCT + PBO
arm group type: Placebo Comparator
arm group label: TCT + AMPH
arm group type: Active Comparator
intervention type: Drug
intervention name: AMPH
description: Suppressing active psychosis with antipsychotics benefits cognitive interventions for schizophrenia, but it is possible that drugs with pro-cognitive effects will specifically, and perhaps synergistically, augment the clinical benefits of cognitive therapies. A "proof of concept" for this approach is found in the use of the pro-extinction drugs to selectively enhance the impact of cognitive therapy for anxiety disorders. In this "proof of concept", a learning-based therapy is paired with a medication that enhances a brain mechanism (extinction) that is both 1) critical to that form of learning, and 2) known to be deficient in some anxiety disorders.
arm group label: TCT + AMPH
intervention type: Drug
intervention name: SHAM
description: Suppressing active psychosis with antipsychotics benefits cognitive interventions for schizophrenia, but it is possible that drugs with pro-cognitive effects will specifically, and perhaps synergistically, augment the clinical benefits of cognitive therapies. A "proof of concept" for this approach is found in the use of the pro-extinction drugs to selectively enhance the impact of cognitive therapy for anxiety disorders. In this "proof of concept", a learning-based therapy is paired with a medication that enhances a brain mechanism (extinction) that is both 1) critical to that form of learning, and 2) known to be deficient in some anxiety disorders.
arm group label: TCT + PBO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Neal R Serdlow, M.D., Ph.D.
role: Principal Investigator
affiliation: UC San Diego
last name: Jo Benrubi, B.A.
phone: 6195432314
email: eyeblinkstudy@ucsd.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Neal R. Swerdlow, M.D., Ph.D.
investigator title: Professor
mesh term: Schizophrenia
mesh term: Psychotic Disorders