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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2027-02-28

Brief Summary

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

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Dose escalation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 PDC-1421 Capsule

1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days

Group Type EXPERIMENTAL

PDC-1421 Capsule

Intervention Type DRUG

PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.

2 PDC-1421 Capsules

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

Group Type EXPERIMENTAL

PDC-1421 Capsule

Intervention Type DRUG

PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.

Interventions

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PDC-1421 Capsule

PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No