What side effects are associated with this type of intervention?

Common treatments for depression in cancer patients include SSRIs (e.g., sertraline, fluoxetine), TCAs (e.g., nortriptyline), and SNRIs (e.g., venlafaxine, duloxetine). SSRIs are generally well-tolerated but can cause side effects such as jitteriness, restlessness, anxiety, headache, sexual dysfunction, gastrointestinal symptoms, and insomnia. TCAs may cause sedation, dry mouth, constipation, urinary retention, and can lower the seizure threshold. SNRIs share some side effects with SSRIs and TCAs, including nausea, dry mouth, dizziness, and increased blood pressure. These side effects should be carefully managed, especially in patients with central nervous system disease.

What prior FDA approvals exist?

The FDA has approved several antidepressants for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine. These medications have been studied extensively for their efficacy and safety in various populations, including those with comorbid conditions like cancer. For instance, duloxetine has been evaluated for its effects on cancer-related neuropathic pain and depression. The ongoing study of PDC-1421 aims to explore similar antidepressant effects specifically in cancer patients with depression, adding to the body of research on effective treatments for this population.

What other types of research exist?

Promising novel alternatives to PDC-1421 for treating depression in cancer patients include: 1) Psilocybin-assisted psychotherapy, which has shown sustained reductions in depression and existential distress in cancer patients. 2) Brexpiprazole adjunctive to antidepressants, which has demonstrated efficacy in patients with inadequate response to previous treatments. 3) Duloxetine, which has been effective in treating mood disorders in cancer patients and is well-tolerated. These alternatives have shown potential in recent studies and could be considered for treatment in 2024.

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PDC-1421 for Depression in Cancer Patients

Phase 1 & 2

Waitlist Available

Led By scott A Irwin, MD/PhD

Research Sponsored by BioLite, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No history of epilepsy

No other concurrent antidepressant medications

Must not have

Have a history of any seizure disorder

Currently being treated with tamoxifen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Awards & highlights

No Placebo-Only Group

Summary

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. The goal is to find the right dose that helps with depression without causing harm.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones may include nausea, headaches, dizziness or sleep issues. The trial will closely monitor participants for any adverse reactions to PDC-1421.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had epilepsy.

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I am not taking any antidepressant medications.

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My cancer was confirmed through a tissue examination.

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My cancer is at Stage I, II, or III.

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I am between 21 and 85 years old.

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I have felt depressed for more than 2 weeks.

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I have felt depressed for more than 2 weeks.

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I can swallow pills.

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I have never had a head injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures.

Select...

I am currently taking tamoxifen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Montgomery-Åsberg Depression Rating Scale (MADRS)

Side effects data

From 2019 Phase 2 trial • 72 Patients • NCT02395978

17%

Glaucoma

17%

Viral upper respirator tract infection

17%

Acne

100%

80%

60%

40%

20%

Study treatment Arm

Part I: 1 PDC-1421 Capsule

Part I: 2 PDC-1421 Capsule

Part II: 2 PDC-1421 Capsule

Part II: 1 PDC-1421 Capsule Plus 1 Placebo

Part II: 2 Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2 PDC-1421 CapsulesExperimental Treatment1 Intervention

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

Group II: 1 PDC-1421 CapsuleExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PDC-1421 Capsule

2015

Completed Phase 2

~150

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), tricyclic and tetracyclic antidepressants, and psychostimulants. SSRIs and SNRIs work by increasing the levels of serotonin and norepinephrine in the brain, which are neurotransmitters associated with mood regulation. Tricyclic and tetracyclic antidepressants also increase neurotransmitter levels but through different mechanisms, often affecting multiple neurotransmitter systems. Psychostimulants, such as methylphenidate, increase dopamine and norepinephrine activity, which can improve mood and energy levels. Understanding these mechanisms is crucial for patients because it helps tailor treatment to individual needs, especially in complex cases like depression in cancer patients, where both mental and physical health are intertwined.

Bulimia nervosa : a review of therapy research.