PDC-1421 for Depression in Cancer Patients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new capsule treatment called PDC-1421 to determine safe and effective doses for treating depression in people with cancer. Participants will take either one or two capsules after meals for 28 days to assess its impact on depression symptoms. Suitable candidates include those diagnosed with Stage I, II, or III cancer, currently undergoing or recently completed cancer treatment like chemotherapy or radiation, and experiencing moderate to severe depressive symptoms for at least two weeks. The trial aims to improve the mental health of cancer patients dealing with depression. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial requires that you stop taking any antidepressant medications at least 2 weeks before starting, and 4 weeks for fluoxetine. You also cannot be currently treated with tamoxifen.
Is there any evidence suggesting that PDC-1421 is likely to be safe for humans?
Research has shown that PDC-1421 is generally safe for people. Most studies have examined its use in treating depression and found no serious side effects. The treatment uses plant extracts, which are often considered safer. However, like any medicine, it might cause mild side effects, such as an upset stomach. As this treatment remains under study, researchers closely monitor its safety. This phase of research aims to ensure PDC-1421's safety and determine the best dose for patients.12345
Why do researchers think this study treatment might be promising?
Unlike the standard of care for depression in cancer patients, which typically includes a combination of antidepressant medications like SSRIs or SNRIs and psychotherapy, PDC-1421 is derived from a natural plant source, offering a potentially new mechanism of action. Researchers are excited about PDC-1421 because it promises an innovative approach by targeting neurotransmitter pathways in a novel way, which might result in faster improvement of depressive symptoms. Additionally, it is administered orally, making it a convenient option for patients who are already managing complex treatment schedules. This could be particularly beneficial for those who need effective relief with minimal disruption to their daily routines.
What evidence suggests that PDC-1421 could be an effective treatment for depression in cancer patients?
Research has shown that PDC-1421 may help treat depression, particularly in individuals with Major Depressive Disorder (MDD). In earlier studies, higher doses of PDC-1421 reduced depression scores by 13.4 points. This trial will test different dosages of PDC-1421 for depression in cancer patients, with one group taking 1 capsule and another group taking 2 capsules, three times daily. Although PDC-1421 is still under investigation for this specific population, early results in similar cases are promising. These findings suggest that PDC-1421 could benefit those dealing with depression.13567
Who Is on the Research Team?
Scott Irwin, MD, PhD
Principal Investigator
Cedars-Sinai Health System
Are You a Good Fit for This Trial?
This trial is for cancer patients aged 21-85 with moderate to severe depression who've had or are having cancer treatment. They must be able to swallow pills, not have a history of serious drug allergies, head trauma, epilepsy, substance abuse in the last 6 months, or use other antidepressants recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 1 or 2 PDC-1421 capsules, trice daily, p.o. after meal for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PDC-1421 Capsule
Trial Overview
The study tests PDC-1421 capsules' safety and effective doses for treating depression in cancer patients. It's looking at how well different doses work and monitoring any side effects that occur during the trial.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
2 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioLite, Inc.
Lead Sponsor
American BriVision Corporation
Collaborator
Citations
A Phase I/II Study of PDC-1421 for Treating Depression in ...
Study Overview. The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.
PDC-1421 for Depression in Cancer Patients
This trial is testing a new medication called PDC-1421 to see if it is safe and effective for cancer patients who also have depression.
3.
ctv.veeva.com
ctv.veeva.com/study/a-phase-i-ii-study-of-pdc-1421-for-treating-depression-in-cancer-patientsA Phase I/II Study of PDC-1421 for Treating Depression in ...
The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.
Corporate Overview
Efficacy assessment: Demonstrated its efficacy for treating Major Depressive. Disorder (MDD) patients from the Phase II clinical studies. • Stability at least ...
Zacks Small-Cap Research
By Per-Protocol (PP) analysis, PDC-1421 showed a dose dependent efficacy toward MDD in which high dose (2 x 380 mg) gave 13.4-point reduction in ...
6.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT03833206/a-phase-i-ii-study-of-pdc-1421-for-treating-depression-in-cancer-patientsA Phase I/II Study of PDC-1421 for Treating Depression in ...
The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.
Zacks Small-Cap Research
Drug: PDC-1421, A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients. With Major Depressive Disorder. Study Director: Richard ...
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