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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

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

Primary outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,277,824 Total Patients Enrolled

Jessica Grayson, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Venlafaxine (Serotonin-Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04977271 — Phase 4

Head and Neck Cancers Research Study Groups: Treatment Group, Control Group

Head and Neck Cancers Clinical Trial 2023: Venlafaxine Highlights & Side Effects. Trial Name: NCT04977271 — Phase 4

Venlafaxine (Serotonin-Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04977271 — Phase 4

Frequently Asked Questions

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

What medical issues does Venlafaxine typically treat?

"Venlafaxine is regularly prescribed for treatment of phobias and social anxiety. Other indications include migraine prophylaxis, neuropathic pain management, and headache relief."

Answered by AI

Does Venlafaxine pose any health hazards to users?

"The therapeutic safety of Venlafaxine, which is approved for the public, was graded a 3 on our internal scale. This corresponds to Phase 4 trials."

Answered by AI

Is this research a pioneering endeavor in its field?

"Presently, 10 trials pertaining to Venlafaxine are ongoing in 19 cities and 2 countries. This drug was initially tested back in 2013, with Jiangsu Hansoh Pharmaceutical Co., Ltd. sponsoring the study of 300 participants through Phase 2 & 3 drug approval stages. Since that time period, 104 studies involving this medication have been concluded successfully."

Answered by AI

What research has been conducted regarding the efficacy of Venlafaxine?

"At the moment, 10 Venlafaxine trials are in progress with 4 of them being within Phase 3. Based mainly in Charleston, South carolina, these studies have a total of 23 sites running clinical tests for this medication."

Answered by AI

Are there currently any open spots for participation in this experiment?

"Patient recruitment for this medical study has been completed. First posted on the 30th of December, 2022 and last updated 10/10/2022, no more participants are being accepted. For those searching for other trials, 1293 melanxholia studies and 10 Venlafaxine clinical trials remain open to new patients."

Answered by AI

What is the current participant count of this clinical investigation?

"This research is no longer actively recruiting. The protocol was listed on December 30th 2022 and had its last update of October 10th 2022. If you're searching for other clinical trials, there are 1,293 studies currently enrolling persons with melancholia; additionally, there are ten Venlafaxine related experiments that need participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mood Disorders in Head and Neck Cancer Patients

Harishanker Jeyarajan 2024. "Mood Disorders in Head and Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04977271.

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