<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/NCT03833206</url>
  </required_header>
  <id_info>
    <org_study_id>ABV-1601-001</org_study_id>
    <nct_id>NCT03833206</nct_id>
  </id_info>
  <brief_title>A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients</brief_title>
  <official_title>A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients: Part I Dose Escalation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioLite, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American BriVision Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>BioLite, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in&#xD;
      cancer patients with depression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 15, 2023</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Dose escalation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Montgomery-Åsberg Depression Rating Scale (MADRS)</measure>
    <time_frame>5 weeks</time_frame>
    <description>Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1, 2, 3, 4, and 5 in patients taking 1 or 2 PDC-1421 capsules. The MADRS is a 10-item checklist including 1) depression [apparent]; 2) depression [reported]; 3) loss of interest; 4) suicidal ideation; 5) tension; 6) reduced appetite; 7) insomnia; 8) difficulty in activities; 9) concentration; and 10) pessimism. The MADRS is administered by a trained interviewer. Each item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 [no sadness] to 6 [extremely despondent]). The total score is used to define treatment response (≥50% reduction from baseline) and partial response (20-49% reduction from baseline). Remission is defined as a score of &lt; 10. The following are used as an interpretation of scores:&#xD;
0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression &gt;34 - severe depression</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>1 PDC-1421 Capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 PDC-1421 Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PDC-1421 Capsule</intervention_name>
    <description>PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.</description>
    <arm_group_label>1 PDC-1421 Capsule</arm_group_label>
    <arm_group_label>2 PDC-1421 Capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility Criteria&#xD;
&#xD;
          -  21 to 85 Years of age&#xD;
&#xD;
          -  Diagnosis of Stage I, II or III cancer&#xD;
&#xD;
          -  Histologically-proven malignancy&#xD;
&#xD;
          -  Receiving or within one year of having received cancer treatment with radiation and/or&#xD;
             chemotherapy&#xD;
&#xD;
          -  Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe&#xD;
             depressive symptoms)&#xD;
&#xD;
          -  Duration of depressive symptoms ≥ 2 weeks by patient report.&#xD;
&#xD;
          -  No active/acute suicidality requiring immediate care or psychiatric hospitalization&#xD;
&#xD;
          -  Sufficient English language proficiency to complete all assessments without assistance&#xD;
&#xD;
          -  Able to swallow pills&#xD;
&#xD;
          -  No severe anemia, defined as hemoglobin &lt; 10 g/dL&#xD;
&#xD;
          -  No history of multiple adverse drug reactions or allergy to study drugs&#xD;
&#xD;
          -  Not pregnant&#xD;
&#xD;
          -  No history of head trauma&#xD;
&#xD;
          -  No history of epilepsy&#xD;
&#xD;
          -  No other concurrent antidepressant medications&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Have a current or previous diagnosis of or history consistent with&#xD;
             obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic&#xD;
             or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise&#xD;
             the study, or major depression with psychotic symptoms, as assessed using the MINI&#xD;
             International Neuropsychiatric Interview (MINI Plus).&#xD;
&#xD;
          -  Have a documented history of an intellectual disability.&#xD;
&#xD;
          -  Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for&#xD;
             fluoxetine).&#xD;
&#xD;
          -  Currently being treated with tamoxifen.&#xD;
&#xD;
          -  Subjects who were non-responsive to two or more courses of antidepressant medications&#xD;
             given at an adequate dosage* for symptom treatment within four weeks, or by the&#xD;
             judgment of the investigator considered to have treatment resistant depression (TRD),&#xD;
             or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation&#xD;
             (TMS) or psychosurgery within the last year.&#xD;
&#xD;
          -  Have a history of any seizure disorder.&#xD;
&#xD;
          -  Any clinically significant abnormal vital sign, ECG, or laboratory values as&#xD;
             determined by the investigator which might interfere with the study.&#xD;
&#xD;
          -  Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale&#xD;
             (C-SSRS). High suicidal risk is indicated by:&#xD;
&#xD;
               1. A positive response to question 4 or 5, indicating endorsement of suicidal&#xD;
                  ideation with at least some intent to act in the past month; and/or&#xD;
&#xD;
               2. A positive response to part two of question 6, indicating the presence of any&#xD;
                  suicidal behavior in the past 3 months.&#xD;
&#xD;
          -  Have a history of substance dependence/abuse** within the past 6 months or a positive&#xD;
             drug screen result during the screening period.&#xD;
&#xD;
          -  Have a history of severe allergies to more than 1 class of medication or multiple&#xD;
             adverse drug reactions.&#xD;
&#xD;
          -  * An adequate dosage of the antidepressant medication is defined as the average of the&#xD;
             usual dose (mg/day) recommended in American Psychiatric Association (APA) Practice&#xD;
             Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition.&#xD;
             E.g. the usual dose of Citalopram is 20-60 mg/day, the adequate dosage is 40 mg/day.&#xD;
&#xD;
          -  ** Tobacco is excluded here, and alcohol abuse is defined as average pure alcohol&#xD;
             intake is more than 112 g (for male) or 56 g (for female) per week and/or with Alcohol&#xD;
             withdrawal syndrome. Pure alcohol intake =% (Concentration or alcohol content) x c.c.&#xD;
             (volume)x 0.79 (density of alcohol). Result of serum ethanol test should be equal to&#xD;
             or lower than 10.0 mg/dL to be determined as eligible for the trial. If test result is&#xD;
             between 10.1 to 29.9 mg/dL, only one re-test is allowed per subject to meet the&#xD;
             criterion. Subject with test result equal to or higher than 30.0 mg/dL is to be&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>scott A Irwin, MD/PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cedars-Sinai Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hsien-Ming Wu, MS</last_name>
    <phone>+886-3-657-9631</phone>
    <email>sonnywu@bioliteinc.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cedars-Sinai Health System</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Scott A Irwin, MD/PhD</last_name>
      <phone>310-423-8344</phone>
      <email>scott.irwin@cshs.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833206
org study id: ABV-1601-001
nct id: NCT03833206
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in
      cancer patients with depression.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Dose escalation
primary purpose: Treatment
masking: None (Open Label)
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
time frame: 5 weeks
description: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1, 2, 3, 4, and 5 in patients taking 1 or 2 PDC-1421 capsules. The MADRS is a 10-item checklist including 1) depression [apparent]; 2) depression [reported]; 3) loss of interest; 4) suicidal ideation; 5) tension; 6) reduced appetite; 7) insomnia; 8) difficulty in activities; 9) concentration; and 10) pessimism. The MADRS is administered by a trained interviewer. Each item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 [no sadness] to 6 [extremely despondent]). The total score is used to define treatment response (≥50% reduction from baseline) and partial response (20-49% reduction from baseline). Remission is defined as a score of < 10. The following are used as an interpretation of scores:
0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
arm group label: 1 PDC-1421 Capsule
arm group type: Experimental
description: 1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
arm group label: 2 PDC-1421 Capsules
arm group type: Experimental
description: 2 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
intervention type: Drug
intervention name: PDC-1421 Capsule
description: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
arm group label: 1 PDC-1421 Capsule
arm group label: 2 PDC-1421 Capsules
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: scott A Irwin, MD/PhD
role: Study Director
affiliation: Cedars-Sinai Health System
last name: Hsien-Ming Wu, MS
phone: +886-3-657-9631
email: sonnywu@bioliteinc.com
facility: 
contact: 
country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major