Mood Disorders in Head and Neck Cancer Patients

NCT04977271 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB-300007057
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to initiate a pharmacotherapy protocol for at-risk patients with newly diagnosed head and neck cancer in order to decrease the incidence of anxiety, depression, and uncontrolled pain during cancer treatment.

Conditions

Depressive Disorder; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

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

  The degree of depression in patients who currently do not show signs of depression at the beginning of undergoing HNC treatment. This will be assessed using the following validated questionnaires: Patient-Health Questionnaire (PHQ-9) and the Quick Inventory of Depressive Symptomatology (QIDS SR-16). For both questionnaires, an increase in score is considered to show a higher degree of depression.

  Baseline to 12 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Drug: Venlafaxine

Control Group

NO INTERVENTION

No intervention will be provided for this group

Interventions

Venlafaxine DRUG

The Immediate Release generic formulation of this drug will be used due to its ability to be crushed for those patients who rely on parenteral administration of medications.

Also known as: Effexor

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 years or older
• Ability to speak and understand English
• Have a recently diagnosed cutaneous or mucosal malignancy
• Scheduled to undergo treatment for their malignancy (surgical or nonsurgical) with curative intent
• Ability to take medication (by mouth or via parenteral route)
• Willing to adhere to the study drug's dosing protocol

You may not qualify if:

• Age less than 18 years
• Inability to speak or understand English
• Primary malignancy of thyroid or parathyroid origin
• Currently meet diagnostic criteria for psychosis, schizophrenia, or moderate/severe major depressive disorder (MDD)
• Currently receiving medication as treatment for depression or anxiety
• Known allergic reaction to components of study drug
• Have uncontrolled pain or chronic pain disorder
• Treatment with another investigational drug or other intervention within 30 days
• Females of child-bearing age who are pregnant or nursing

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Depressive Disorder; Head and Neck Neoplasms

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Jessica Grayson, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: January 5, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share