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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether online therapy or medication more effectively treats depression in individuals with non-metastatic breast cancer. Participants will be randomly assigned to 12 weeks of either tele-interpersonal psychotherapy (therapy sessions over Zoom) or Venlafaxine HCl ER, a serotonin reuptake inhibitor (a type of antidepressant medication). The trial will also examine blood inflammation to assess its impact on medication effectiveness. This trial suits individuals diagnosed with Stage I-III breast cancer in the past 10 years who are experiencing major depression. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for depression.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Interpersonal Psychotherapy (IPT) safely treats depression. Studies have found it improves depression in women with breast cancer without causing major side effects. Patients have responded well to this therapy, even when provided through online sessions.

Venlafaxine, a type of antidepressant, has also been well-researched. The FDA has approved it for treating depression, and it is considered safe for most people. However, some users experience side effects like nausea or headaches. There is also a small risk of increased suicidal thoughts in some young adults, so monitoring for these symptoms is important.

Both treatments in this study are generally well-tolerated, and existing safety data support their use in treating depression. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine Tele-Interpersonal Psychotherapy (IPT) and Venlafaxine HCl ER, offering a dual approach to managing depression in breast cancer patients. Unlike typical antidepressants that primarily focus on chemical imbalances, Tele-IPT addresses the emotional impacts of life changes, like a cancer diagnosis, through secure tele-therapy sessions. Venlafaxine HCl ER, a serotonin-norepinephrine reuptake inhibitor, is favored for its minimal interference with cancer treatments, and its dosages can be tailored to individual needs under expert guidance. This approach not only targets depression from both a psychological and chemical angle but also provides flexibility and convenience through telemedicine, which is a significant advancement for patients dealing with both cancer and depression.

What evidence suggests that this trial's treatments could be effective for depression in breast cancer patients?

Research has shown that venlafaxine, one of the treatments in this trial, effectively treats major depression. It successfully reduces depression symptoms in many people, including those with breast cancer. Interpersonal psychotherapy (IPT), another treatment option in this trial, also effectively addresses major depression. Studies have found that IPT improves mood by addressing how life events, such as a cancer diagnosis, impact feelings. Specifically, patients with both depression and breast cancer have experienced significant symptom improvements with IPT. ^{1 3 4 5 6}

Who Is on the Research Team?

John C Markowitz, MD

Principal Investigator

Research Psychiatrist/ Professor of Clinical Psychiatry

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30343455/

A Randomized Trial of Interpersonal Psychotherapy, ... Among patients who completed treatment, all three psychotherapies were associated with similar, meaningful improvements in depression.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6391220/

A Randomized Trial of Interpersonal Psychotherapy ... This study, the largest to date, compared outcomes of three evidence-based, twelve-week therapies in treating major depressive disorder among women with breast ...

3. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.psychotherapy.2014.68.4.489

A Pilot Study of Interpersonal Psychotherapy for Depressed ... Our findings of improved depressive symptoms among women with breast cancer and MDD treated with IPT are consistent with findings from prior ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04973930

Study Details | NCT04973930 | Feasibility Trial of Tele-IPT ... Interpersonal psychotherapy is a time-limited, affect-focused treatment of repeatedly demonstrated efficacy for major depression in the general population. It ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1531756/full

Tailoring interpersonal psychotherapy to psycho-oncology ... Results regarding the efficacy of remote IPC in oncology settings were inconclusive (23). Two studies investigated individual IPT in oncology ...

6. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct01191580

Interpersonal Therapy for Depression in Breast Cancer The investigators propose a randomized clinical trial to compare the efficacy of Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), ...