xml: <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/NCT06026917</url>
    </required_header>
    <id_info>
      <org_study_id>SMHC-234</org_study_id>
      <nct_id>NCT06026917</nct_id>
    </id_info>
    <brief_title>Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)</brief_title>
    <official_title>A Single-Arm, Open-Label, Exploratory Mechanistic Validation (PoM) Clinical Trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain Using 11C-CFT Positron Emission Tomography (PET)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Mental Health Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Yantai University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shanghai Mental Health Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study was a single-arm, open-label clinical study to assess dopamine transporter&#xD;
        occupancy in the brain of patients with depression using 11C-CFT positron emission tomography&#xD;
        (PET).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 17, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of Dopamine Transporters Occupancy in the Basal Ganglia（Positron emission tomography with 11C-CFT） was determine by SUVr of the Basal Ganglia DAT.</measure>
      <time_frame>from baseline to day 14 and 42</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in the total score of 10 items on the Montgomery-Asperger's Depression Scale (MADRS) from baseline</measure>
      <time_frame>from baseline to day 42</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the Scores anhedonia</measure>
      <time_frame>from baseline to day 42</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence Rate of Adverse event</measure>
      <time_frame>from baseline to day 42</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Major Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>Toludesvenlafaxine hydrochloride sustained-release tablets</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>40 mg/tablet, 80mg/tablet, 40 mg~160mg each time, once a day, for 42 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Toludesvenlafaxine hydrochloride sustained-release tablets</intervention_name>
      <description>D1~D6, 40mg/ tablet, 1 tablet per time, once a day, D7~D10, 80mg/ tablet, 1 tablet per time, once a day, D11~D42, 80mg/ tablet, 2 tablets per time, once a day. For subjects who cannot tolerate 160mg, the dose may be reduced to 80mg/ dose once daily. After the number of subjects receiving 160mg/ dose reached 6, the remaining subjects received D11~D42, 80mg/ tablet, one tablet each time, once a day.</description>
      <arm_group_label>Toludesvenlafaxine hydrochloride sustained-release tablets</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female outpatients aged 18 years and older;&#xD;
  &#xD;
            -  Meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition)&#xD;
               diagnostic criteria for depression (296.2/296.3), and not accompanied by psychotic&#xD;
               features;&#xD;
  &#xD;
            -  A Montgomery - Asberg Depression Rating Scale (MADRS) total score ≥ 26 at screening;&#xD;
  &#xD;
            -  Anhedonia scale score &lt; 28.5 at screening;&#xD;
  &#xD;
            -  Subjects and their partners take effective non-drug contraceptive measures (such as&#xD;
               abstinence and condom with intravaginal spermicide) throughout the study and within 6&#xD;
               months after the end of the study, and have no sperm donation plan;&#xD;
  &#xD;
            -  The subject is willing to participate in the trial and sign the informed consent form&#xD;
               and is able to comply with the scheduled visits, treatment plan, laboratory tests and&#xD;
               other study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known to have a history of allergy to any component of the investigational drug or&#xD;
               similar drugs, or allergic constitution (defined as allergy to two or more drugs or&#xD;
               food) and the investigator determines that it is not appropriate to participate in the&#xD;
               trial;&#xD;
  &#xD;
            -  Significant suicide attempt or behavior, MADRS scale item 10 (suicidal ideation) score&#xD;
               ≥ 4 points;&#xD;
  &#xD;
            -  Pregnant or lactating women, recently planned pregnancy;&#xD;
  &#xD;
            -  Those who meet DSM-5 diagnosis of schizophrenia spectrum or other psychoses, bipolar&#xD;
               or related disorders, obsessive-compulsive and related disorders, traumatic and&#xD;
               stress-related disorders, dissociative disorders, anorexia nervosa or bulimia,&#xD;
               personality disorders, substance-related or alcohol use disorders (except nicotine or&#xD;
               caffeine);&#xD;
  &#xD;
            -  Patients with depression secondary to other mental or physical diseases or with a past&#xD;
               medical history or family history of movement disorders (such as Parkinson's disease);&#xD;
  &#xD;
            -  Receipt of any contrast agent or radiopharmaceutical within 48 hours before the&#xD;
               application of the trial drug, or planned application of contrast agent within 24&#xD;
               hours after the administration of the trial drug;&#xD;
  &#xD;
            -  Contraindications to PET or MRI (magnetic resonance imaging) (including&#xD;
               claustrophobia, alcohol allergy, cardiac pacemaker and neurostimulator in the body,&#xD;
               metal foreign body or tracer component allergy, etc.); in the past 10 years,Major&#xD;
               occupational exposure to ionizing radiation (e.g., more than 50 nanovolts/year) or&#xD;
               exposure to radioactive substances or ionizing radiation for therapeutic or research&#xD;
               purposes;&#xD;
  &#xD;
            -  Patients who stopped antidepressant drugs for less than 7 half-lives (at least 2 weeks&#xD;
               for monoamine oxidase inhibitors and at least 1 month for fluoxetine) before entering&#xD;
               the group;&#xD;
  &#xD;
            -  History of gastrointestinal disease known to interfere with drug absorption or&#xD;
               excretion or history of surgery known to interfere with drug absorption or excretion;&#xD;
  &#xD;
            -  History of increased intraocular pressure or narrow glaucoma;&#xD;
  &#xD;
            -  Total bilirubin (TBIL) value 1.5 times higher than the upper limit of normal, alanine&#xD;
               aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times higher than the&#xD;
               upper limit of normal, thyroid stimulating hormone (TSH) higher than the normal range&#xD;
               or glomerular filtration rate (GFR) ≤ 70 mL/min at screening or baseline;&#xD;
  &#xD;
            -  Patients with serious unstable cardiovascular disease, liver disease, kidney disease,&#xD;
               blood disease, endocrine disease, central nervous system and other physical diseases&#xD;
               or medical history, or the subjects are not suitable for the study judged by the&#xD;
               investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>YIFENG SHEN, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Mental Health Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>YIFENG SHEN, MD</last_name>
      <phone>+8618017311040</phone>
      <email>shenyifeng@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Mental Health Center</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200030</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Depressive Disorder, Major</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026917
  org study id: SMHC-234
  nct id: NCT06026917
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was a single-arm, open-label clinical study to assess dopamine transporter
        occupancy in the brain of patients with depression using 11C-CFT positron emission tomography
        (PET).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percentage of Dopamine Transporters Occupancy in the Basal Ganglia（Positron emission tomography with 11C-CFT） was determine by SUVr of the Basal Ganglia DAT.
  time frame: from baseline to day 14 and 42
  measure: Changes in the total score of 10 items on the Montgomery-Asperger's Depression Scale (MADRS) from baseline
  time frame: from baseline to day 42
  measure: Changes in the Scores anhedonia
  time frame: from baseline to day 42
  measure: Incidence Rate of Adverse event
  time frame: from baseline to day 42
  arm group label: Toludesvenlafaxine hydrochloride sustained-release tablets
  arm group type: Experimental
  description: 40 mg/tablet, 80mg/tablet, 40 mg~160mg each time, once a day, for 42 days
  intervention type: Drug
  intervention name: Toludesvenlafaxine hydrochloride sustained-release tablets
  description: D1~D6, 40mg/ tablet, 1 tablet per time, once a day, D7~D10, 80mg/ tablet, 1 tablet per time, once a day, D11~D42, 80mg/ tablet, 2 tablets per time, once a day. For subjects who cannot tolerate 160mg, the dose may be reduced to 80mg/ dose once daily. After the number of subjects receiving 160mg/ dose reached 6, the remaining subjects received D11~D42, 80mg/ tablet, one tablet each time, once a day.
  arm group label: Toludesvenlafaxine hydrochloride sustained-release tablets
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: YIFENG SHEN, MD
  role: Principal Investigator
  affiliation: Shanghai Mental Health Center
  last name: YIFENG SHEN, MD
  phone: +8618017311040
  email: shenyifeng@yahoo.com
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major
  sharing ipd: No