A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients: Part I Dose Escalation
BioLite, Inc.
Summary
The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.
Eligibility
- Age range
- 21–85 years
- Sex
- All
- 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…
Interventions
- DrugPDC-1421 Capsule
PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
Location
- Cedars-Sinai Health SystemLos Angeles, California