<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/NCT03239210</url>
  </required_header>
  <id_info>
    <org_study_id>17-01608</org_study_id>
    <nct_id>NCT03239210</nct_id>
  </id_info>
  <brief_title>Effects of Ondansetron in Obsessive-compulsive and Tic Disorders</brief_title>
  <official_title>Effects of Ondansetron in Obsessive-compulsive and Tic Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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>
      This project investigates the use of 4 weeks of 24 mg/day ondansetron as compared to placebo&#xD;
      on symptoms and brain functioning in patients with obsessive-compulsive disorder (OCD) and&#xD;
      tic disorders (TD). Patients will be randomized to receive ondansetron or placebo for 4&#xD;
      weeks, with MRI scans and symptom assessments occurring at baseline (before any drug) and at&#xD;
      the end of the 4 weeks. Patients will also be asked to come into the lab approximately 2&#xD;
      weeks into the trial for symptom assessments. The investigators hypothesize that after 4&#xD;
      weeks there will be greater reduction from baseline in sensory symptoms and the activation of&#xD;
      the insula and sensorimotor cortex compared for ondansetron as compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many psychiatric disorders are associated with altered sensory experiences arising from&#xD;
      within the body. Examples include increased experience of sensations or urges in muscles,&#xD;
      skins, joints or visceral organs in Tic/Tourette's Disorders, OCD patients with symptoms of&#xD;
      &quot;not just right experiences&quot; or disgust sensitivity, and other disorders such as&#xD;
      trichotillomania or excoriation disorder. In OCD, these sensory phenomena occur in&#xD;
      approximately half of patients, are associated with earlier age of onset, and may be harder&#xD;
      to treat with classic cognitive-behavioral approaches to OCD. Of interest, sensory phenomena&#xD;
      in OCD are associated with Tourette's syndrome and respond to pharmacological treatments&#xD;
      primarily used for tics. As such, abnormal sensory processing may be a basic mechanism that&#xD;
      links various psychiatric disorders.&#xD;
&#xD;
      The process of attending to body sensations is referred to as interoception, abnormality of&#xD;
      which may be related to sensory phenomena. Research has revealed a cortical interoceptive&#xD;
      circuit involving insula, anterior cingulate cortex (ACC), and sensorimotor cortex.&#xD;
      Ondansetron (OND) is a good candidate for the modulation of the above-described interoceptive&#xD;
      circuit. It is a selective 5-HT3 (serotonin) receptor antagonist that acts on both peripheral&#xD;
      and central receptors. OND has long been used to treat nausea and vomiting due to&#xD;
      chemotherapy, radiation therapy, anesthesia, and opioid-induced emesis. It has also been used&#xD;
      alone or as adjunctive therapy for the treatment of both OCD and Tourette's disorder, showing&#xD;
      some efficacy in small clinical trials. The mechanisms by which ondansetron improves symptoms&#xD;
      in OCD and tic disorders are unknown, although the investigator's earlier study found that&#xD;
      single doses of ondansetron reduce activation of insula and somatosensory cortex in healthy&#xD;
      controls. As a follow-up to this work, the current protocol will compare the effects of 24&#xD;
      mg/day of ondansetron vs. placebo for 4 weeks in patients with OCD or Tic Disorders on&#xD;
      symptoms and brain functioning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2017</start_date>
  <completion_date type="Actual">May 16, 2022</completion_date>
  <primary_completion_date type="Actual">May 16, 2022</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Brain Activation - Insula Cortex</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>Change in brain activation is measured by percentage blood-oxygen-level dependent (BOLD) signal change in the insula cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed &quot;body-focused&quot; videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left insula regions of interest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Brain Activation - Somatosensory Cortex</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>Change in brain activation is measured by percentage blood-oxygen-level dependent (BOLD) signal change in the somatosensory cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed &quot;body-focused&quot; videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left postcentral gyrus regions of interest.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Sensory Phenomena Scale (SPS) Score</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>The SPS is a clinician-rated scale that assesses presence or absence of sensory phenomena. It contains a checklist with examples of different types of sensory phenomena, including physical sensations, &quot;just right&quot; sensations, incompleteness, general energy or inner tension buildup, and urges. The total score ranges from 0-15, with higher scores indicating more severe sensory phenomena. A score of 6 or more is defined as moderate or greater severity of sensory phenomena. An decrease in scores indicates severity decreased during the observational period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>Y-BOCS is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity. A decrease in scores indicates symptom severity decreased during the observational period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Yale Global Tic Severity Scale (YGTSS) Score</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The total score is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity. A decrease in scores indicates severity decreased during the observational period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <condition>Tic Disorders</condition>
  <condition>Tourette Syndrome</condition>
  <arm_group>
    <arm_group_label>Ondansetron (OND)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>24 mg/day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (PL)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo pill</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting</description>
    <arm_group_label>Ondansetron (OND)</arm_group_label>
    <other_name>Zofran</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo equivalent</description>
    <arm_group_label>Placebo (PL)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be medically healthy, between 18 and 60 years of age&#xD;
&#xD;
          -  Fluent (speaking and writing) in English&#xD;
&#xD;
          -  Patients must have a current diagnosis of obsessive-compulsive disorder (OCD) or tic&#xD;
             disorder (OCD) according to Diagnostic and Statistical Manual of Mental Disorders&#xD;
             (DSM-5) criteria with moderate or greater disorder severity and moderate or greater&#xD;
             severity of sensory phenomena&#xD;
&#xD;
          -  Patients must be unmedicated or taking antidepressants, stable for at least 6 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Present or previous diagnosis of any psychosis, bipolar disorder, or major&#xD;
             developmental disorder (autism/Asperger's disorder, pervasive developmental disorder).&#xD;
             Present diagnosis of alcohol or substance use disorder (moderate or severe) will also&#xD;
             be exclusionary.&#xD;
&#xD;
          -  Any disability or health problem that prevents them from completing study procedures&#xD;
             (e.g. color blindness, severe carpal tunnel syndrome, etc.).&#xD;
&#xD;
          -  History of organic mental syndromes, head trauma, migraines, seizures, other central&#xD;
             nervous system (CNS) neurological disease, or significant medical illness other than&#xD;
             that listed above.&#xD;
&#xD;
          -  Pregnant or nursing women will be excluded.&#xD;
&#xD;
          -  Subjects with a medical condition or other predisposition that increases the risk of&#xD;
             adverse effects when taking ondansetron. These include, but are not limited to,&#xD;
             individuals with drug allergies or known hypersensitivity to ondansetron (or other&#xD;
             5-HT3 antagonists), heart disease, congestive heart failure, heart rhythm disorder,&#xD;
             congenital long QT syndrome, electrolyte abnormalities (e.g., hypokalemia,&#xD;
             hypomagnesemia) or hepatic impairment.&#xD;
&#xD;
          -  Subjects who report taking apomorphine will be excluded.&#xD;
&#xD;
          -  Subjects with abnormal EKG will either be excluded from participation, or referred to&#xD;
             a cardiologist for further assessment of eligibility.&#xD;
&#xD;
          -  Subjects with abnormal liver function or electrolytes (as determined by blood test)&#xD;
             will be excluded from participation if a study team physician determines it is unsafe&#xD;
             for them to participate.&#xD;
&#xD;
          -  Cross-reactivity with other 5-HT3 antagonists has been reported, so any individual&#xD;
             taking a 5-HT3 antagonist will be excluded.&#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_official>
    <last_name>Emily Stern, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Nathan S. Kline Institute for Psychiatric Research</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <results_first_submitted>May 16, 2023</results_first_submitted>
  <results_first_submitted_qc>June 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2023</results_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain Function</keyword>
  <keyword>functional magnetic resonance imaging (fMRI)</keyword>
  <keyword>Sensory processing</keyword>
  <keyword>Obsessive-Compulsive Disorder</keyword>
  <keyword>OCD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Tics</mesh_term>
    <mesh_term>Tic Disorders</mesh_term>
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ondansetron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data Sharing Plan The project will be registered and results reported on ClinicalTrials.gov. Neuroimaging data and associated files (e.g. behavioral response data generated during tasks) will be de-identified and provided for use by other researchers. De-identification will include removal of sensitive data from image file headers (e.g. name, date of birth). The anonymized final data set will be made available upon request, with an announcement on the lab website providing information on how to obtain the data. In addition, final data will be uploaded to an appropriate public database, such as the Open fMRI project, for broad availability. Data sharing will comply with local, state, and federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA), as well as institutional policies and review</ipd_description>
    <ipd_time_frame>Data will be made available when the study team has published the outcomes of our primary and secondary analyses.</ipd_time_frame>
    <ipd_access_criteria>A written request must be made to the PI for access to the data. This request will involve providing an abstract detailing the planned analyses and utilization of the data and a signed agreement not to share the data with any other person.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 8, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03239210/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ondansetron (OND)</title>
          <description>24 mg/day for 4 weeks&#xD;
Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting</description>
        </group>
        <group group_id="P2">
          <title>Placebo (PL)</title>
          <description>Placebo pill&#xD;
Placebo: placebo equivalent</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by subject (personal reasons)</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by subject (reported medical side effects)</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ondansetron (OND)</title>
          <description>24 mg/day for 4 weeks&#xD;
Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting</description>
        </group>
        <group group_id="B2">
          <title>Placebo (PL)</title>
          <description>Placebo pill&#xD;
Placebo: placebo equivalent</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="51"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31" spread="9.96"/>
                    <measurement group_id="B2" value="29" spread="12.52"/>
                    <measurement group_id="B3" value="30" spread="11.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Brain Activation - Insula Cortex</title>
        <description>Change in brain activation is measured by percentage blood-oxygen-level dependent (BOLD) signal change in the insula cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed &quot;body-focused&quot; videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left insula regions of interest.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron (OND)</title>
            <description>24 mg/day for 4 weeks&#xD;
Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting</description>
          </group>
          <group group_id="O2">
            <title>Placebo (PL)</title>
            <description>Placebo pill&#xD;
Placebo: placebo equivalent</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Brain Activation - Insula Cortex</title>
          <description>Change in brain activation is measured by percentage blood-oxygen-level dependent (BOLD) signal change in the insula cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed &quot;body-focused&quot; videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left insula regions of interest.</description>
          <units>Percent BOLD Signal Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.071" spread="0.21"/>
                    <measurement group_id="O2" value="-0.0094" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Brain Activation - Somatosensory Cortex</title>
        <description>Change in brain activation is measured by percentage blood-oxygen-level dependent (BOLD) signal change in the somatosensory cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed &quot;body-focused&quot; videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left postcentral gyrus regions of interest.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron (OND)</title>
            <description>24 mg/day for 4 weeks&#xD;
Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting</description>
          </group>
          <group group_id="O2">
            <title>Placebo (PL)</title>
            <description>Placebo pill&#xD;
Placebo: placebo equivalent</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Brain Activation - Somatosensory Cortex</title>
          <description>Change in brain activation is measured by percentage blood-oxygen-level dependent (BOLD) signal change in the somatosensory cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed &quot;body-focused&quot; videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left postcentral gyrus regions of interest.</description>
          <units>Percent BOLD Signal Change</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.097" lower_limit="-0.12" upper_limit="0.09"/>
                    <measurement group_id="O2" value="-0.0052" lower_limit="-0.14" upper_limit="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sensory Phenomena Scale (SPS) Score</title>
        <description>The SPS is a clinician-rated scale that assesses presence or absence of sensory phenomena. It contains a checklist with examples of different types of sensory phenomena, including physical sensations, &quot;just right&quot; sensations, incompleteness, general energy or inner tension buildup, and urges. The total score ranges from 0-15, with higher scores indicating more severe sensory phenomena. A score of 6 or more is defined as moderate or greater severity of sensory phenomena. An decrease in scores indicates severity decreased during the observational period.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron (OND)</title>
            <description>24 mg/day for 4 weeks&#xD;
Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting</description>
          </group>
          <group group_id="O2">
            <title>Placebo (PL)</title>
            <description>Placebo pill&#xD;
Placebo: placebo equivalent</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sensory Phenomena Scale (SPS) Score</title>
          <description>The SPS is a clinician-rated scale that assesses presence or absence of sensory phenomena. It contains a checklist with examples of different types of sensory phenomena, including physical sensations, &quot;just right&quot; sensations, incompleteness, general energy or inner tension buildup, and urges. The total score ranges from 0-15, with higher scores indicating more severe sensory phenomena. A score of 6 or more is defined as moderate or greater severity of sensory phenomena. An decrease in scores indicates severity decreased during the observational period.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.646" spread="2.098"/>
                    <measurement group_id="O2" value="1.204" spread="2.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score</title>
        <description>Y-BOCS is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity. A decrease in scores indicates symptom severity decreased during the observational period.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron (OND)</title>
            <description>24 mg/day for 4 weeks&#xD;
Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting</description>
          </group>
          <group group_id="O2">
            <title>Placebo (PL)</title>
            <description>Placebo pill&#xD;
Placebo: placebo equivalent</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score</title>
          <description>Y-BOCS is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity. A decrease in scores indicates symptom severity decreased during the observational period.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" lower_limit="1.52" upper_limit="5.75"/>
                    <measurement group_id="O2" value="1" lower_limit="0.26" upper_limit="5.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Yale Global Tic Severity Scale (YGTSS) Score</title>
        <description>The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The total score is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity. A decrease in scores indicates severity decreased during the observational period.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>Sample is based on 10 patients with motor/phonic tic symptoms.</population>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron (OND)</title>
            <description>24 mg/day for 4 weeks&#xD;
Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting</description>
          </group>
          <group group_id="O2">
            <title>Placebo (PL)</title>
            <description>Placebo pill&#xD;
Placebo: placebo equivalent</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Yale Global Tic Severity Scale (YGTSS) Score</title>
          <description>The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The total score is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity. A decrease in scores indicates severity decreased during the observational period.</description>
          <population>Sample is based on 10 patients with motor/phonic tic symptoms.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="2.97"/>
                    <measurement group_id="O2" value="3.6" spread="6.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks).</time_frame>
      <desc>Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ondansetron (OND)</title>
          <description>24 mg/day for 4 weeks&#xD;
Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting</description>
        </group>
        <group group_id="E2">
          <title>Placebo (PL)</title>
          <description>Placebo pill&#xD;
Placebo: placebo equivalent</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Heartburn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>General malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Transaminitis (transient)</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Tremors</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Light headed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Poor concentration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Poor coordination</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Sleeping too much</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Vivid dreams</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Increase in suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Decreased libido</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Frequent urination</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menstrual irregularity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Difficulty breathing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Pruritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Increased perspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nicolette Recchia</name_or_title>
      <organization>NYU Langone Health</organization>
      <phone>845-398-6563</phone>
      <email>nicolette.recchia@nyulangone.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03239210
org study id: 17-01608
nct id: NCT03239210
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This project investigates the use of 4 weeks of 24 mg/day ondansetron as compared to placebo
      on symptoms and brain functioning in patients with obsessive-compulsive disorder (OCD) and
      tic disorders (TD). Patients will be randomized to receive ondansetron or placebo for 4
      weeks, with MRI scans and symptom assessments occurring at baseline (before any drug) and at
      the end of the 4 weeks. Patients will also be asked to come into the lab approximately 2
      weeks into the trial for symptom assessments. The investigators hypothesize that after 4
      weeks there will be greater reduction from baseline in sensory symptoms and the activation of
      the insula and sensorimotor cortex compared for ondansetron as compared to placebo.
Many psychiatric disorders are associated with altered sensory experiences arising from
      within the body. Examples include increased experience of sensations or urges in muscles,
      skins, joints or visceral organs in Tic/Tourette's Disorders, OCD patients with symptoms of
      "not just right experiences" or disgust sensitivity, and other disorders such as
      trichotillomania or excoriation disorder. In OCD, these sensory phenomena occur in
      approximately half of patients, are associated with earlier age of onset, and may be harder
      to treat with classic cognitive-behavioral approaches to OCD. Of interest, sensory phenomena
      in OCD are associated with Tourette's syndrome and respond to pharmacological treatments
      primarily used for tics. As such, abnormal sensory processing may be a basic mechanism that
      links various psychiatric disorders.

      The process of attending to body sensations is referred to as interoception, abnormality of
      which may be related to sensory phenomena. Research has revealed a cortical interoceptive
      circuit involving insula, anterior cingulate cortex (ACC), and sensorimotor cortex.
      Ondansetron (OND) is a good candidate for the modulation of the above-described interoceptive
      circuit. It is a selective 5-HT3 (serotonin) receptor antagonist that acts on both peripheral
      and central receptors. OND has long been used to treat nausea and vomiting due to
      chemotherapy, radiation therapy, anesthesia, and opioid-induced emesis. It has also been used
      alone or as adjunctive therapy for the treatment of both OCD and Tourette's disorder, showing
      some efficacy in small clinical trials. The mechanisms by which ondansetron improves symptoms
      in OCD and tic disorders are unknown, although the investigator's earlier study found that
      single doses of ondansetron reduce activation of insula and somatosensory cortex in healthy
      controls. As a follow-up to this work, the current protocol will compare the effects of 24
      mg/day of ondansetron vs. placebo for 4 weeks in patients with OCD or Tic Disorders on
      symptoms and brain functioning.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Brain Activation - Insula Cortex
time frame: Baseline, Week 4
description: Change in brain activation is measured by percentage blood-oxygen-level dependent (BOLD) signal change in the insula cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed "body-focused" videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left insula regions of interest.
measure: Change in Brain Activation - Somatosensory Cortex
time frame: Baseline, Week 4
description: Change in brain activation is measured by percentage blood-oxygen-level dependent (BOLD) signal change in the somatosensory cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed "body-focused" videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left postcentral gyrus regions of interest.
measure: Change in Sensory Phenomena Scale (SPS) Score
time frame: Baseline, Week 4
description: The SPS is a clinician-rated scale that assesses presence or absence of sensory phenomena. It contains a checklist with examples of different types of sensory phenomena, including physical sensations, "just right" sensations, incompleteness, general energy or inner tension buildup, and urges. The total score ranges from 0-15, with higher scores indicating more severe sensory phenomena. A score of 6 or more is defined as moderate or greater severity of sensory phenomena. An decrease in scores indicates severity decreased during the observational period.
measure: Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score
time frame: Baseline, Week 4
description: Y-BOCS is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity. A decrease in scores indicates symptom severity decreased during the observational period.
measure: Change in Yale Global Tic Severity Scale (YGTSS) Score
time frame: Baseline, Week 4
description: The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The total score is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity. A decrease in scores indicates severity decreased during the observational period.
arm group label: Ondansetron (OND)
arm group type: Active Comparator
description: 24 mg/day for 4 weeks
arm group label: Placebo (PL)
arm group type: Placebo Comparator
description: Placebo pill
intervention type: Drug
intervention name: Ondansetron
description: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting
arm group label: Ondansetron (OND)
other name: Zofran
intervention type: Drug
intervention name: Placebo
description: placebo equivalent
arm group label: Placebo (PL)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Emily Stern, PhD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tourette Syndrome
mesh term: Tics
mesh term: Tic Disorders
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
mesh term: Ondansetron
sharing ipd: Yes
ipd description: Data Sharing Plan The project will be registered and results reported on ClinicalTrials.gov. Neuroimaging data and associated files (e.g. behavioral response data generated during tasks) will be de-identified and provided for use by other researchers. De-identification will include removal of sensitive data from image file headers (e.g. name, date of birth). The anonymized final data set will be made available upon request, with an announcement on the lab website providing information on how to obtain the data. In addition, final data will be uploaded to an appropriate public database, such as the Open fMRI project, for broad availability. Data sharing will comply with local, state, and federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA), as well as institutional policies and review
ipd time frame: Data will be made available when the study team has published the outcomes of our primary and secondary analyses.
ipd access criteria: A written request must be made to the PI for access to the data. This request will involve providing an abstract detailing the planned analyses and utilization of the data and a signed agreement not to share the data with any other person.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 