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

Part of paid clinical trials in Los Angeles, California.

Sponsor
BioLite, Inc.
Study ID
NCT03833206
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jan 15, 2027
Status verified
Apr 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1 PDC-1421 Capsule
    1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
  • Experimental: 2 PDC-1421 Capsules
    2 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days

Primary Outcome Measure

Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Health SystemLos AngelesCalifornia90048
Scott A Irwin, MD/PhD
[email protected]
310-423-8344

Find similar trials in Los Angeles, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Cedars-Sinai Health System· Los Angeles, CA

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