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

Sponsor
BioLite, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT03833206
Collaborator
(none)
12
1
2
5.9
2

Study Details

Study Description

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
  • Drug: PDC-1421 Capsule
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Dose escalationDose 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
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars-Sinai Health System Los Angeles California United States 90048

Sponsors and Collaborators

  • BioLite, Inc.

Investigators

  • Study Director: scott A Irwin, MD/PhD, Cedars-Sinai Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BioLite, Inc.
ClinicalTrials.gov Identifier:
NCT03833206
Other Study ID Numbers:
  • ABV-1601-001
First Posted:
Feb 6, 2019
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022