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Serotonin-Norepinephrine Reuptake Inhibitor

Venlafaxine for Depression in Head and Neck Cancer Patients

Phase 4

Waitlist Available

Led By Jessica Grayson, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Scheduled to undergo treatment for their malignancy (surgical or nonsurgical) with curative intent

Be older than 18 years old

Must not have

Currently meet diagnostic criteria for psychosis, schizophrenia, or moderate/severe major depressive disorder (MDD)

Have uncontrolled pain or chronic pain disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will help develop a new protocol to manage anxiety, depression, and pain in patients with head and neck cancer.

Who is the study for?

This trial is for adults over 18 with newly diagnosed head and neck cancer who are about to start treatment. They must be able to take oral medication, speak English, and commit to the study's duration. Pregnant or nursing women, those on current depression/anxiety meds, with certain thyroid cancers or severe mental health conditions can't join.

What is being tested?

The trial is testing Venlafaxine as a way to reduce anxiety, depression, and pain in patients undergoing treatment for head and neck cancer. It aims to establish a protocol for early pharmacotherapy in these patients.

What are the potential side effects?

Venlafaxine may cause side effects such as nausea, dizziness, sleep disturbances, changes in appetite or weight, dry mouth, constipation or sexual dysfunction. Some people might also experience increased blood pressure.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for a treatment aimed at curing my cancer.

Exclusion Criteria

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

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I have been diagnosed with psychosis, schizophrenia, or severe depression.

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I have chronic pain that is not well-managed.

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My cancer originates from the thyroid or parathyroid.

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I am currently taking medication for depression or anxiety.

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I am under 18 years old.

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I am pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The rate of depression in patients undergoing treatment for head and neck cancer (HNC)

Side effects data

From 2009 Phase 4 trial • 220 Patients • NCT00177671

Suicide Attempt

Myocardial infarcation with congestive heart failure

stroke

100%

80%

60%

40%

20%

Study treatment Arm

Donepezil

Placebo

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

Experimental Treatment

Active Control

Group I: Treatment GroupExperimental Treatment1 Intervention

Starting dose of oral venlafaxine immediate release (IR) 37.5 mg BID, to be taken with food. The dosing will be increased at a rate of 75mg per week for 3 weeks, to reach a desired dose of 300mg per day, taken as 150mg BID. For patients with hepatic impairment, severe renal impairment, or end-stage kidney disease, the starting dose is 37.5 mg once daily, and the dose is increased by increments of 37.5 mg per day, to a maximum of 187.5 mg per day, taken as 93.75 mg BID.

Group II: Control GroupActive Control1 Intervention

No intervention will be provided for this group

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venlafaxine

2007

Completed Phase 4

~3259640

0 / 7Eligibility criteria met