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Tele-Serotonin Reuptake Inhibitor for Depression (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change over twelve weeks

Awards & highlights

IPT Trial Summary

This trial will show whether interpersonal psychotherapy or a serotonin reuptake inhibitor is more acceptable to patients with breast cancer and depression, and whether one treatment is superior in reducing depression symptoms and inflammation.

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.Check my eligibility

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.See study design

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.

IPT Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with major depression without psychosis.

IPT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hamilton Depression Rating Scale

Secondary outcome measures

C-Reactive Protein

PROMIS

Patient Health Questionnaire - 9 (PHQ-9)

+3 more

IPT 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 / 1Eligibility criteria met

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Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor

475 Previous Clinical Trials

153,887 Total Patients Enrolled

82 Trials studying Depression

10,722 Patients Enrolled for Depression

Columbia UniversityOTHER

1,433 Previous Clinical Trials

2,447,239 Total Patients Enrolled

48 Trials studying Depression

38,203 Patients Enrolled for Depression

John C Markowitz, MDPrincipal InvestigatorResearch Psychiatrist/ Professor of Clinical Psychiatry

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which patients would be most likely to experience benefits from this clinical trial?

"The ideal patient for this study would have a diagnosis of breast cancer, be between 18-80 years old, and there are approximately 20 patients needed in total."

Answered by AI

How many people are participating in this research study at the most?

"That is correct. The information available on clinicaltrials.gov verifies that this study, which was initially posted on March 1st 2022, has open recruitment at the moment. They are looking for 20 individuals from a single location to participate in the trial"

Answered by AI

Does this experiment exclude anyone over the age of 18 from participating?

"According to the parameters set by the researchers, only patients aged 18 to 80 can qualify for this trial. Out of the 3232 clinical trials taking place for patients over 65, this study is just one. For people under 18 years old, there are a total of 190 different trials underway."

Answered by AI

What conditions does Tele-Serotonin Reuptake Inhibitor help alleviate?

"Common mental health disorders that can be mitigated by Tele-Serotonin Reuptake Inhibitors include major depressive disorder, menopause-induced anxiety, and generalized anxiety disorder."

Answered by AI