Not yet recruiting NCT03833206

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

Phase I / Phase II Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: PDC-1421 Capsule.
Who it may be relevant to: Registry conditions: Major Depressive Disorder. Basic parameters: 21 years — 85 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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.

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.

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

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:

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
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT03833206 · ABV-1601-001