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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: PDC-1421 Capsule

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Hsien-Ming Wu, MS; Phone Number: +886-3-657-9631; Email: sonnywu@bioliteinc.com
• Study Contact Backup: Name: Shirley Chiu, Ph.D.; Phone Number: +886-3-657-9631; Email: shirleychiu@bio1st.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Health System
      • Contact: Scott A Irwin, MD/PhD; Phone Number: 310-423-8344; Email: scott.irwin@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 < 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	5 weeks

Collaborators and Investigators

• Sponsor: BioLite, Inc.
• Collaborators: American BriVision Corporation
• Investigators: Principal Investigator: scott A Irwin, MD/PhD, Cedars-Sinai Health System

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: ABV-1601-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No