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Tele-IPT + Venlafaxine for Depression and Breast Cancer (IPT Trial)

Phase 3

Recruiting

Led By John C Markowitz, MD

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

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

Must have

Episode of major depressive disorder without psychotic features on Structured Clinical Interview for DSM-5 (SCID-5)

Be older than 18 years old

Must not have

Known metastases

History of non-response to IPT (>4 sessions)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change over twelve weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests talk therapy and antidepressant medications for patients with early-stage breast cancer and major depression. Talk therapy helps manage emotions and relationships, while medications increase serotonin levels to improve mood.

Who is the study for?

This trial is for patients with non-metastatic breast cancer (Stage I-III, diagnosed within the last 10 years) and major depression. Participants must have a significant level of depression without psychotic features and be willing to give written consent.

What is being tested?

The study compares two treatments for depression in breast cancer patients: interpersonal psychotherapy via Zoom or medication with Venlafaxine HCl ER. The goal is to see if participants accept these treatments and improve in their depressive symptoms.

What are the potential side effects?

Potential side effects from Venlafaxine may include nausea, dizziness, sleep disturbances, increased blood pressure, and sexual dysfunction. Psychotherapy generally does not have physical side effects but can sometimes cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with major depression without psychosis.

Exclusion Criteria

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

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My cancer has spread to other parts of my body.

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I have tried IPT therapy for more than 4 sessions without improvement.

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I haven't responded to long-term use of venlafaxine or escitalopram.

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I am too ill or confused to participate in a trial.

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I cannot fill out questionnaires in English by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change over twelve weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change over twelve weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change over twelve 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

Hamilton Depression Rating Scale

Secondary study objectives

C-Reactive Protein

PROMIS

Patient Health Questionnaire - 9 (PHQ-9)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Tele-Serotonin Reuptake InhibitorActive Control1 Intervention

Both venlafaxine and escitalopram are FDA-approved treatments with demonstrated efficacy in treating major depression in the general population. Although little formal research has been done in treating patients with depression and breast cancer, these two are the favored treatments among serotonin reuptake inhibitors due to minimal interference with oncotherapy. The choice between prescribing these two study medications will depend upon prior treatment history. Venlafaxine XR will be serially titrated under expert psychopharmacologist tele-guidance from 75 mg to 300 mg daily, depending on clinical response and tolerance. Escitalopram will similarly be dosed between 5 mg and 30 mg daily.

Group II: Tele-Interpersonal Psychotherapy (IPT)Active Control1 Intervention

Interpersonal psychotherapy is a time-limited, affect-focused treatment of repeatedly demonstrated efficacy for major depression in the general population. It was also helpful to patients with comorbid depression and breast cancer in our prior randomized controlled trial. IPT focuses on the connection between upsetting life circumstances (e.g., diagnosis of breast cancer) and their effect on mood, and vice versa. We have considerable experience, enhanced by the Covid-19 lockdown, in delivering IPT as a HIPAA-secure tele-therapy.

0 / 6Eligibility criteria met