Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metastatic Breast Cancer

NCT04973930 | Suspended Phase 3 FDA Drug

• 1 other identifier: Velocity
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder; Breast Cancer; Venlafaxine

Keywords

Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale

  Observer-rated canonical measure of depression; 24-item version; higher scores= greater severity

  Change over twelve weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Tele-Interpersonal Psychotherapy (IPT)

ACTIVE COMPARATOR

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.

Behavioral: Interpersonal Psychotherapy

Tele-Serotonin Reuptake Inhibitor

ACTIVE COMPARATOR

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.

Drug: Venlafaxine HCl ER

Interventions

Interpersonal Psychotherapy BEHAVIORAL

Time-limited, affect-focused, empirically supported psychotherapy

Also known as: IPT

Tele-Interpersonal Psychotherapy (IPT)

Venlafaxine HCl ER DRUG

FDA-approved antidepressant medications

Also known as: Escitalopram Oral Tablet

Tele-Serotonin Reuptake Inhibitor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• item Hamilton Depression Rating Scale score ≥18
• written informed consent

You may not qualify if:

• Psychosis (by SCID-5 interview)
• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Columbia University: collaborator

Study Sites (1)

Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (4)

• Weissmann MM, Markowitz JC, Klerman GL: The Guide to Interpersonal Psychotherapy. New York, Oxford University Press, 2018. ISBN-13: 978-0190662592

  BACKGROUND

• Blanco C, Markowitz JC, Hellerstein DJ, Nezu AM, Wall M, Olfson M, Chen Y, Levenson J, Onishi M, Varona C, Okuda M, Hershman DL. A randomized trial of interpersonal psychotherapy, problem solving therapy, and supportive therapy for major depressive disorder in women with breast cancer. Breast Cancer Res Treat. 2019 Jan;173(2):353-364. doi: 10.1007/s10549-018-4994-5. Epub 2018 Oct 20.

  PMID: 30343455 RESULT

• Blanco C, Markowitz JC, Hershman DL, Levenson JA, Wang S, Grann VR. A Pilot Study of Interpersonal Psychotherapy for Depressed Women with Breast Cancer. Am J Psychother. 2014;68(4):489-95. doi: 10.1176/appi.psychotherapy.2014.68.4.489.

  PMID: 26453348 RESULT

• Markowitz JC, Hellerstein DJ, Falabella G, Lan M, Levenson J, Crew KD, Hershman DL. Psychopharmaphobia: Elevated fear of antidepressant medication among patients with major depression and breast cancer. Gen Hosp Psychiatry. 2023 Jul-Aug;83:117-122. doi: 10.1016/j.genhosppsych.2023.05.005. Epub 2023 May 6. No abstract available.

  PMID: 37172545 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Breast Neoplasms

Interventions

Interpersonal Psychotherapy; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John C Markowitz, MD

  Research Psychiatrist/ Professor of Clinical Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators will be blinded to treatment and therapist. Patients will be alerted not to mention the type of treatment they are receiving or the name of their therapist to independent evaluators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist/Professor of Clinical Psychiatry

Model Details: Pilot randomized 12-week clinical trial of tele-interpersonal psychotherapy vs. tele-serotonin reuptake inhibitor (escitalopram or venlafaxine) for patients with major depressive disorder and breast cancer to test the acceptability of randomization and treatment.

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 22, 2021
• Study Start: March 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)