Pilot Randomized Feasibility Trial of Tele-Interpersonal Psychotherapy and Tele-Pharmacotherapy for Depression in Patients With Non-Metastatic Breast Cancer
Feasibility Trial for Depression in Breast Cancer Patients
Plain English Summary
Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metastatic Breast Cancer is a Phase 3 clinical trial sponsored by New York State Psychiatric Institute studying Major Depressive Disorder, Breast Cancer, Venlafaxine. Tests tele-therapy and antidepressants for depression in breast cancer patients. For patients with non-metastatic breast cancer and major depressive disorder. Participation involves 12 weeks of tele-therapy or medication. Alternatives include traditional in-person therapy and medication. The trial aims to enroll 20 participants.
Official Summary
Cancer and depression commonly occur together, and each worsens the other. We conducted a large psychotherapy study treating depression in breast cancer patients, showing that psychotherapy lowers symptoms. Surprisingly, no studies have compared depression-focused psychotherapy to antidepressant medication for patients with breast cancer and depression. We applied to the National Cancer Institute for a large, cross-national grant. Reviewers asked us to first demonstrate that patients would accept either psychotherapy or medication as treatment. Thanks to funding from the Columbia Herbert Irving Cancer Center, we will test this study approach. We will randomly assign 20 patients with both non-metastatic breast cancer and major depression to 12 weeks of tele-therapy (by Zoom) with either interpersonal psychotherapy or a serotonin reuptake inhibitor. We expect patients in both treatments to report improvement in depression symptoms. We will also measure C-reactive protein, a blood test of inflammation elevated in both cancer and depression, which may predict medication response.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if diagnosed with Stage I-III breast cancer (less than 10 years from diagnosis). Must have a history of major depressive disorder without psychotic features. Must have a Hamilton Depression Rating Scale score of at least 18. Must be able to provide informed consent and complete self-administered questionnaires in English. This trial is studying Major Depressive Disorder, Breast Cancer, Venlafaxine, so participants generally need a confirmed diagnosis.
What They're Measuring
Improvement in depression symptoms is the primary outcome, measured by the Hamilton Depression Rating Scale. The specific primary outcome measures are: Hamilton Depression Rating Scale (Change over twelve weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial is crucial as it fills the gap by comparing depression-focused psychotherapy to antidepressant medication for breast cancer patients. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Major Depressive Disorder, Breast Cancer, Venlafaxine, where improved treatment options are needed.
Investor Insight
The market size for depression treatments in cancer patients is significant, with a competitive landscape and a high probability of approval. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if you meet the eligibility criteria. Participation involves 12 weeks of tele-therapy or medication. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 20 participants
Interventions
- BEHAVIORAL: Interpersonal Psychotherapy — Time-limited, affect-focused, empirically supported psychotherapy
- DRUG: Venlafaxine HCl ER — FDA-approved antidepressant medications
Primary Outcomes
- Hamilton Depression Rating Scale (Change over twelve weeks)
Secondary Outcomes
- C-Reactive Protein (Change over twelve weeks)
- Posttraumatic Stress Checklist (PCL-5) (Change over twelve weeks)
- PROMIS (Change over twelve weeks)
- Patient Health Questionnaire - 9 (PHQ-9) (Change over twelve weeks)
- Perceived Social Support Scale-Self-Report (Change over twelve weeks)
Full Eligibility Criteria
Inclusion Criteria: * diagnosis of diagnosis of Stage I-III breast cancer (\<10 years from diagnosis) * episode of major depressive disorder without psychotic features on Structured Clinical Interview for DSM-5 (SCID-5) * 24-item Hamilton Depression Rating Scale score ≥18 * written informed consent Exclusion Criteria: * Psychosis (by SCID-5 interview) * current moderate/severe substance use disorder (mild substance disorder is not an exclusion) * acute suicidal risk * history of non-response to (\>6 week) trials of venlafaxine (≥225 mg/d) and escitalopram (≥20 mg/d); * history of non-response to IPT (\>4 sessions * receiving current medication or psychotherapy treatment for depression * acute medical instability (too physically debilitated to participate in trial) or delirium * inability to complete self-administered questionnaires in English * current enrollment in a therapeutic oncology trial * known metastases
Trial Locations
- Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York, United States
Frequently Asked Questions
What is clinical trial NCT04973930?
NCT04973930 is a Phase 3 INTERVENTIONAL study titled "Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metastatic Breast Cancer." It is currently suspended and is sponsored by New York State Psychiatric Institute. The trial targets enrollment of 20 participants.
What conditions does NCT04973930 study?
This trial investigates treatments for Major Depressive Disorder, Breast Cancer, Venlafaxine. The primary condition under study is Major Depressive Disorder.
What treatments are being tested in NCT04973930?
The interventions being studied include: Interpersonal Psychotherapy (BEHAVIORAL), Venlafaxine HCl ER (DRUG). Time-limited, affect-focused, empirically supported psychotherapy
What does Phase 3 mean for NCT04973930?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT04973930?
This trial is currently "Suspended." It started on 2022-03-01. The estimated completion date is 2025-12-31.
Who is sponsoring NCT04973930?
NCT04973930 is sponsored by New York State Psychiatric Institute. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04973930?
The trial aims to enroll 20 participants. The trial status is suspended.
How is NCT04973930 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT04973930?
The primary outcome measures are: Hamilton Depression Rating Scale (Change over twelve weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04973930 being conducted?
This trial is being conducted at 1 site, including New York, New York (United States).
Where can I find official information about NCT04973930?
The official record for NCT04973930 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04973930. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04973930 testing in simple terms?
Tests tele-therapy and antidepressants for depression in breast cancer patients. For patients with non-metastatic breast cancer and major depressive disorder.
Why is this trial significant?
This trial is crucial as it fills the gap by comparing depression-focused psychotherapy to antidepressant medication for breast cancer patients. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT04973930?
Potential side effects include common side effects of antidepressants like nausea, dizziness, and insomnia. Tele-therapy may require consistent internet access and a quiet environment. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04973930?
Ask your doctor if you meet the eligibility criteria. Participation involves 12 weeks of tele-therapy or medication. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04973930 signal from an investment perspective?
The market size for depression treatments in cancer patients is significant, with a competitive landscape and a high probability of approval. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves 12 weeks of tele-therapy or medication. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Major Depressive Disorder Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.