[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03833206":3,"trial-entities:NCT03833206":95,"trial-summary:NCT03833206":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":62,"locations":65,"central_contacts":81,"overall_officials":89,"references":93,"see_also_links":94},"NCT03833206","ABV-1601-001","A Phase I\u002FII Study of PDC-1421 for Treating Depression in Cancer Patients","A Phase I\u002FII Study of PDC-1421 for Treating Depression in Cancer Patients: Part I Dose Escalation","NOT_YET_RECRUITING","2028-02-28","2026-04","2026-04-20","2027-01-15","BioLite, Inc.","INDUSTRY",false,"The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.",null,[19],"Major Depressive Disorder",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},12,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","PDC-1421 Capsule","PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.",[35,36],"1 PDC-1421 Capsule","2 PDC-1421 Capsules",[38],{"measure":39,"description":40,"timeFrame":41},"Montgomery-Åsberg Depression Rating Scale (MADRS)","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 \\\u003C 10. The following are used as an interpretation of scores:\n\n0 to 6 - normal\u002Fsymptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \\>34 - severe depression","5 weeks",[],"ALL","21 Years","85 Years",{"inclusion":47,"exclusion":48,"raw_text":61},[],[49,50,51,52,53,54,55,56,57,58,59,60],"Have a current or previous diagnosis of or history consistent with obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise the study, or major depression with psychotic symptoms, as assessed using the MINI International Neuropsychiatric Interview (MINI Plus).","Have a documented history of an intellectual disability.","Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine).","Currently being treated with tamoxifen.","Subjects who were non-responsive to two or more courses of antidepressant medications given at an adequate dosage\\* for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year.","Have a history of any seizure disorder.","Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study.","Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by:","Have a history of substance dependence\u002Fabuse\\*\\* within the past 6 months or a positive drug screen result during the screening period.","Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.","\\* An adequate dosage of the antidepressant medication is defined as the average of the usual dose (mg\u002Fday) recommended in American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition. E.g. the usual dose of Citalopram is 20-60 mg\u002Fday, the adequate dosage is 40 mg\u002Fday.","\\*\\* Tobacco is excluded here, and alcohol abuse is defined as average pure alcohol intake is more than 112 g (for male) or 56 g (for female) per week and\u002For with Alcohol withdrawal syndrome. Pure alcohol intake =% (Concentration or alcohol content) x c.c. (volume)x 0.79 (density of alcohol). Result of serum ethanol test should be equal to or lower than 10.0 mg\u002FdL to be determined as eligible for the trial. If test result is between 10.1 to 29.9 mg\u002FdL, only one re-test is allowed per subject to meet the criterion. Subject with test result equal to or higher than 30.0 mg\u002FdL is to be excluded.","Eligibility Criteria\n\n* 21 to 85 Years of age\n* Diagnosis of Stage I, II or III cancer\n* Histologically-proven malignancy\n* Receiving or within one year of having received cancer treatment with radiation and\u002For chemotherapy\n* Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe depressive symptoms)\n* Duration of depressive symptoms ≥ 2 weeks by patient report.\n* No active\u002Facute suicidality requiring immediate care or psychiatric hospitalization\n* Sufficient English language proficiency to complete all assessments without assistance\n* Able to swallow pills\n* No severe anemia, defined as hemoglobin \\\u003C 10 g\u002FdL\n* No history of multiple adverse drug reactions or allergy to study drugs\n* Not pregnant\n* No history of head trauma\n* No history of epilepsy\n* No other concurrent antidepressant medications\n\nExclusion Criteria\n\n* Have a current or previous diagnosis of or history consistent with obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise the study, or major depression with psychotic symptoms, as assessed using the MINI International Neuropsychiatric Interview (MINI Plus).\n* Have a documented history of an intellectual disability.\n* Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine).\n* Currently being treated with tamoxifen.\n* Subjects who were non-responsive to two or more courses of antidepressant medications given at an adequate dosage\\* for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year.\n* Have a history of any seizure disorder.\n* Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study.\n* Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by:\n\n  1. A positive response to question 4 or 5, indicating endorsement of suicidal ideation with at least some intent to act in the past month; and\u002For\n  2. A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months.\n* Have a history of substance dependence\u002Fabuse\\*\\* within the past 6 months or a positive drug screen result during the screening period.\n* Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.\n* \\* An adequate dosage of the antidepressant medication is defined as the average of the usual dose (mg\u002Fday) recommended in American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition. E.g. the usual dose of Citalopram is 20-60 mg\u002Fday, the adequate dosage is 40 mg\u002Fday.\n* \\*\\* Tobacco is excluded here, and alcohol abuse is defined as average pure alcohol intake is more than 112 g (for male) or 56 g (for female) per week and\u002For with Alcohol withdrawal syndrome. Pure alcohol intake =% (Concentration or alcohol content) x c.c. (volume)x 0.79 (density of alcohol). Result of serum ethanol test should be equal to or lower than 10.0 mg\u002FdL to be determined as eligible for the trial. If test result is between 10.1 to 29.9 mg\u002FdL, only one re-test is allowed per subject to meet the criterion. Subject with test result equal to or higher than 30.0 mg\u002FdL is to be excluded.",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":78},"Cedars-Sinai Health System","Los Angeles","California","90048","United States",[73],{"name":74,"role":75,"phone":76,"email":77},"Scott A Irwin, MD\u002FPhD","CONTACT","310-423-8344","scott.irwin@cshs.org",{"lat":79,"lon":80},34.05223,-118.24368,[82,86],{"name":83,"role":75,"phone":84,"email":85},"Shirley Chiu, Ph.D.","+886-3-657-9631","shirleychiu@bio1st.com",{"name":87,"role":75,"phone":84,"email":88},"Hsien-Ming Wu, MS","sonnywu@bioliteinc.com",[90],{"name":91,"affiliation":67,"role":92},"scott A Irwin, MD\u002FPhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":96,"biomarkers":99},[97,98],"Malignant Neoplasm","Unipolar Depression",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.","completed","PDC-1421 for Depression in Cancer Patients","This study is testing PDC-1421 Capsule, a botanical investigational drug made from Radix Polygalae, to see if it is safe and what doses are effective for treating depression in cancer patients. You may be able to join if you are 21 to 85 years old, have Stage I, II, or III cancer, and are currently receiving or have recently received cancer treatment. You also need to have moderate to severe depressive symptoms (a score of 20 or higher on the Montgomery-Åsberg Depression Rating Scale, or MADRS) for at least two weeks. The study will measure changes in your depression symptoms using the MADRS after 5 weeks. This study plans to enroll 12 participants, but its current recruitment status is unclear.","Your depression symptoms will be measured at 5 weeks after starting the study.",120,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]