Tele-IPT + Venlafaxine for Depression and Breast Cancer

(IPT Trial)

Overseen By David J Hellerstein, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: New York State Psychiatric Institute

Must not be taking: Antidepressants

Disqualifiers: Psychosis, Severe substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants are not currently receiving medication or psychotherapy treatment for depression, so you would need to stop any current depression treatments before joining.

What data supports the effectiveness of the treatment Interpersonal Psychotherapy (IPT) for depression in patients with breast cancer?

A pilot study showed that Interpersonal Psychotherapy (IPT) helped reduce depression symptoms and improve overall functioning in women with breast cancer, suggesting it could be a promising treatment for this group. ^{1 2 3 4 5}

Is Interpersonal Psychotherapy (IPT) safe for treating depression in humans?

Interpersonal Psychotherapy (IPT) has been studied in many trials and is considered a safe treatment for depression, including in people with breast cancer. It is a structured therapy that has been recommended in practice guidelines for treating depression. ^{4 5 6 7 8}

How is the treatment of Tele-IPT + Venlafaxine for depression and breast cancer different from other treatments?

This treatment is unique because it combines interpersonal psychotherapy (IPT), which focuses on improving personal relationships and social functioning, with Venlafaxine, a medication that helps balance brain chemicals to improve mood. Additionally, the therapy is delivered via telephone, making it more accessible for patients undergoing cancer treatment. ^{4 5 7 9 10}

Research Team

John C Markowitz, MD

Principal Investigator

Research Psychiatrist/ Professor of Clinical Psychiatry

Eligibility Criteria

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.

Inclusion Criteria

Written informed consent

I was diagnosed with Stage I-III breast cancer less than 10 years ago.

I have been diagnosed with major depression without psychosis.

Exclusion Criteria

I am currently receiving treatment for depression.

My cancer has spread to other parts of my body.

Current enrollment in a therapeutic oncology trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants receive either tele-interpersonal psychotherapy or tele-pharmacotherapy for 12 weeks

12 weeks

Weekly tele-sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Interpersonal Psychotherapy
• Venlafaxine HCl ER

Trial Overview 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.

Participant Groups

Group I: Tele-Serotonin Reuptake Inhibitor Active Control 1 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 Control 1 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.

Interpersonal Psychotherapy is already approved in United States for the following indications:

Approved in United States as Interpersonal Psychotherapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Findings from Research

Brief Interpersonal Psychotherapy (IPT-B) is an effective eight-session adaptation of standard Interpersonal Psychotherapy (IPT) designed for individuals who may not be able to commit to longer therapy, providing similar benefits in fewer sessions.

Empirical evidence from multiple studies, including randomized controlled trials, supports IPT-B's efficacy in delivering rapid relief from depression while also being resource-efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Interpersonal Psychotherapy (IPT-B): Overview and Review of Evidence. Swartz, HA., Grote, NK., Graham, P.[2019]

Interpersonal psychotherapy (IPT) is supported by strong evidence as an effective treatment for postpartum depression (PPD), focusing on the interpersonal challenges women face after childbirth.

IPT is delivered in 12 sessions and is particularly relevant for addressing issues like role transitions and interpersonal disputes, making it a practical and effective option for primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An approach to interpersonal psychotherapy for postpartum depression: focusing on interpersonal changes. Grigoriadis, S., Ravitz, P.[2022]

Interpersonal psychotherapy (IPT) was successfully integrated into a psychiatry residency program over a 5-year period, highlighting its effectiveness as a brief, evidence-based treatment for acute major depression.

The implementation process not only enhanced the training of residents in evidence-based treatment approaches but also helped convey essential psychotherapy concepts, indicating its value in medical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing interpersonal psychotherapy in a psychiatry residency training program. Lichtmacher, J., Eisendrath, SJ., Haller, E.[2006]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy: current status. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

A systematic review of research findings on the efficacy of interpersonal therapy for depressive disorders. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Brief Interpersonal Psychotherapy (IPT-B): Overview and Review of Evidence. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of Interpersonal Psychotherapy for Depressed Women with Breast Cancer. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy for Finnish community patients with moderate to severe major depression and comorbidities: a pilot feasibility study. [2018]

6. Canada pubmed.ncbi.nlm.nih.gov

An approach to interpersonal psychotherapy for postpartum depression: focusing on interpersonal changes. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Implementing interpersonal psychotherapy in a psychiatry residency training program. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy for depression: a meta-analysis. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A pilot study of interpersonal psychotherapy by telephone with cancer patients and their partners. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy for depression? The need to define its ecological niche. [2009]