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A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients: Part I

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ClinicalTrials.gov Identifier: NCT03833206
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
BioLite, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: PDC-1421 Capsule Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients: Part I Dose Escalation
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 PDC-1421 Capsule
1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
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.

Experimental: 2 PDC-1421 Capsules
2 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
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.




Primary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 5 weeks ]

    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




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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria

  • 21 to 85 Years of age
  • Diagnosis of Stage I, II or III cancer
  • Histologically-proven malignancy
  • Receiving or within one year of having received cancer treatment with radiation and/or chemotherapy
  • Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe depressive symptoms)
  • Duration of depressive symptoms ≥ 2 weeks by patient report.
  • No active/acute suicidality requiring immediate care or psychiatric hospitalization
  • Sufficient English language proficiency to complete all assessments without assistance
  • Able to swallow pills
  • No severe anemia, defined as hemoglobin < 10 g/dL
  • No history of multiple adverse drug reactions or allergy to study drugs
  • Not pregnant
  • No history of head trauma
  • No history of epilepsy
  • No other concurrent antidepressant medications

Exclusion Criteria

  • 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:

    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/or
    2. A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months.
  • Have a history of substance dependence/abuse** 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/day) 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/day, the adequate dosage is 40 mg/day.
  • ** 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/or 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/dL to be determined as eligible for the trial. If test result is between 10.1 to 29.9 mg/dL, only one re-test is allowed per subject to meet the criterion. Subject with test result equal to or higher than 30.0 mg/dL is to be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833206


Contacts
Contact: Frank C Liu, MD +886-3-668-5386 liu3763@bioliteinc.com

Locations
United States, California
Cedars-Sinai Health System Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Scott A Irwin, MD/PhD    310-423-8344    scott.irwin@cshs.org   
Sponsors and Collaborators
BioLite, Inc.
Investigators
Study Director: scott A Irwin, MD/PhD Cedars-Sinai Health System

Responsible Party: BioLite, Inc.
ClinicalTrials.gov Identifier: NCT03833206     History of Changes
Other Study ID Numbers: ABV-1601-001
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders