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/NCT05970510</url>
    </required_header>
    <id_info>
      <org_study_id>LY03005/CT-CHN-307</org_study_id>
      <nct_id>NCT05970510</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.</brief_title>
    <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Participants With Generalized Anxiety Disorder.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Luye Pharma Group Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Luye Pharma Group Ltd.</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>
        The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride&#xD;
        Sustained-release Tablets compared to placebo in adults participants with generalized anxiety&#xD;
        disorder over a period of 8 weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study consists of two periods: screening period (2 weeks) and double-blind treatment&#xD;
        period (8 weeks). After the screening period, generalized anxiety disorder patients who&#xD;
        satisfies the inclusion criteria are randomly assigned in the 1:1:1 ratio to receive either&#xD;
        placebo or Toludesvenlafaxine Hydrochloride Sustained-release Tablets at two dose levels (80&#xD;
        ,160 mg/day) for 8 weeks. Participants are evaluated at screening, baseline visits and&#xD;
        double-blind period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2026</primary_completion_date>
    <phase>Phase 3</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 from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>The HAMA Scale consist of 14 items that include psychic, somatic, and behavioral symptoms associated with anxiety. Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 56, with high scores indicating greater illness severity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale psychic factor score (Items 1~6 and Item 14) at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>The psychic factor score is the sum of items 1-6 and items 14(including items such as anxious mood, tension, fear, insomnia, and behavioral symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>The somatic factor score is the sum of items 7-13(including items such as cardiovascular, respiratory, and gastrointestinal symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1（Anxious mood）Score at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2（Tension）Score at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with response at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>Response was defined as a≥50% reduction from baseline to endpoint in the HAMA total score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with remission at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>Remission was defined as a HAMA total score ≤7 points at endpoint</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Global Impression Scale - improvement (CGI-I) score at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>The CGI-I scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>The CGI-S scale is a 7-point scale to rate the severity of the patient's illness. Patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>The SDS scale consists of 3 items evaluating impairment in work/school， social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>The scale consists of 3 items evaluating impairment in work/school， social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of adverse effects (AEs)</measure>
      <time_frame>from baseline to week 8</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint</measure>
      <time_frame>from baseline to week 8</time_frame>
      <description>The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a &quot;yes&quot; answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a &quot;yes&quot; answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">555</enrollment>
    <condition>Generalized Anxiety Disorder</condition>
    <arm_group>
      <arm_group_label>Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>orally once a day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>orally once a day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>orally once a day</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg</intervention_name>
      <description>orally once a day</description>
      <arm_group_label>Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg</intervention_name>
      <description>orally once a day</description>
      <arm_group_label>Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>placebo</intervention_name>
      <description>orally once a day</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female aged 18 to 65 years subjects;&#xD;
  &#xD;
            2. Meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5)&#xD;
               criteria for Generalized Anxiety Disorder;&#xD;
  &#xD;
            3. Have a Hamilton Anxiety(HAMA) Rating Scale total score ≥21 points at screening and&#xD;
               baseline;&#xD;
  &#xD;
            4. Have a Hamilton Anxiety(HAMA) Rating Scale score ≥2 points on both item 1(anxious&#xD;
               mood) and item 2(tension) at screening and baseline;&#xD;
  &#xD;
            5. Have a clinical Global Impression -severity illness (CGI-S) score≥4 points at&#xD;
               screening and baseline.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Meet the diagnostic criteria for other psychotic disorders(defined by DSM-5, except&#xD;
               for GAD), including major depression disorder within 6 months prior to screening ,&#xD;
               presence or history of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar&#xD;
               and Related Disorders, Obsessive-Compulsive and related Disorders, post-traumatic&#xD;
               stress disorder, anorexia nervosa or bulimia and personality disorder;&#xD;
  &#xD;
            2. Meet the diagnostic criteria for substance or alcohol abuse (defined by DSM-5, except&#xD;
               for nicotine or caffeine) within 6 months prior to screening;&#xD;
  &#xD;
            3. Have anxious symtoms secondary to other physical illnesses or mental illnesses and&#xD;
               anxious induced by psychoactive substance;&#xD;
  &#xD;
            4. Withdrawal psychotropic drugs within 5 half-lives (at least 2 weeks for monoamine&#xD;
               oxidase inhibitors, at least 1 month for fluoxetine, and at least 2 weeks for&#xD;
               benzodiazepines or barbiturates) prior to randomization;&#xD;
  &#xD;
            5. Have received psychosurgery or physical therapy for psychiatric illness (such as&#xD;
               transcranial magnetic stimulation) within 3 months prior to screening;&#xD;
  &#xD;
            6. Have received systematic psychotherapy or other non-drug therapies for psychiatric&#xD;
               disorders (such as acupuncture or light therapy) within 6 weeks prior to screening;&#xD;
  &#xD;
            7. Concomitant with serious and unstable illness, including cardiovascular, hepatic,&#xD;
               renal, hematological, endocrine illness, malignant tumors and other physical illness;&#xD;
  &#xD;
            8. Have a history of seizures (except for seizures caused by febrile convulsions in&#xD;
               childhood);&#xD;
  &#xD;
            9. Have a history of gastrointestinal disease or surgery known to interfere with&#xD;
               investigation product absorption or excretion;&#xD;
  &#xD;
           10. Known or suspected allergic or severe reaction to investigation product or inactive&#xD;
               ingredients; or allergic to venlafaxine or desvenlafaxine; or allergic constitution&#xD;
               (defined as allergic to two or more drugs or food) and unfit to participate judged by&#xD;
               investigator;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zhang Hongyan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University Sixth Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhang Hongyan</last_name>
      <phone>13601237138</phone>
      <email>hongyanzhang@bjmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking University Sixth Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Toludesvenlafaxine Hydrochloride Sustained-release Tablet</keyword>
    <keyword>generalized anxiety disorder</keyword>
    <keyword>efficacy</keyword>
    <keyword>safety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT05970510
  org study id: LY03005/CT-CHN-307
  nct id: NCT05970510
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride
        Sustained-release Tablets compared to placebo in adults participants with generalized anxiety
        disorder over a period of 8 weeks.
  The study consists of two periods: screening period (2 weeks) and double-blind treatment
        period (8 weeks). After the screening period, generalized anxiety disorder patients who
        satisfies the inclusion criteria are randomly assigned in the 1:1:1 ratio to receive either
        placebo or Toludesvenlafaxine Hydrochloride Sustained-release Tablets at two dose levels (80
        ,160 mg/day) for 8 weeks. Participants are evaluated at screening, baseline visits and
        double-blind period.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint
  time frame: from baseline to week 8
  description: The HAMA Scale consist of 14 items that include psychic, somatic, and behavioral symptoms associated with anxiety. Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 56, with high scores indicating greater illness severity.
  measure: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale psychic factor score (Items 1~6 and Item 14) at endpoint
  time frame: from baseline to week 8
  description: The psychic factor score is the sum of items 1-6 and items 14(including items such as anxious mood, tension, fear, insomnia, and behavioral symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.
  measure: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint
  time frame: from baseline to week 8
  description: The somatic factor score is the sum of items 7-13(including items such as cardiovascular, respiratory, and gastrointestinal symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.
  measure: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1（Anxious mood）Score at endpoint
  time frame: from baseline to week 8
  description: The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.
  measure: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2（Tension）Score at endpoint
  time frame: from baseline to week 8
  description: The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.
  measure: Percentage of participants with response at endpoint
  time frame: from baseline to week 8
  description: Response was defined as a≥50% reduction from baseline to endpoint in the HAMA total score.
  measure: Percentage of participants with remission at endpoint
  time frame: from baseline to week 8
  description: Remission was defined as a HAMA total score ≤7 points at endpoint
  measure: Clinical Global Impression Scale - improvement (CGI-I) score at endpoint
  time frame: from baseline to week 8
  description: The CGI-I scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
  measure: Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint
  time frame: from baseline to week 8
  description: The CGI-S scale is a 7-point scale to rate the severity of the patient's illness. Patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
  measure: Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint
  time frame: from baseline to week 8
  description: The SDS scale consists of 3 items evaluating impairment in work/school， social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).
  measure: Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint
  time frame: from baseline to week 8
  description: The scale consists of 3 items evaluating impairment in work/school， social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).
  measure: Incidence and severity of adverse effects (AEs)
  time frame: from baseline to week 8
  measure: Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint
  time frame: from baseline to week 8
  description: The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
  arm group label: Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group
  arm group type: Experimental
  description: orally once a day
  arm group label: Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group
  arm group type: Experimental
  description: orally once a day
  arm group label: Placebo
  arm group type: Sham Comparator
  description: orally once a day
  intervention type: Drug
  intervention name: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg
  description: orally once a day
  arm group label: Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group
  intervention type: Drug
  intervention name: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg
  description: orally once a day
  arm group label: Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group
  intervention type: Drug
  intervention name: placebo
  description: orally once a day
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Zhang Hongyan
  role: Principal Investigator
  affiliation: Peking University Sixth Hospital
  last name: Zhang Hongyan
  phone: 13601237138
  email: hongyanzhang@bjmu.edu.cn
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Anxiety Disorders