Venlafaxine for the Prevention of Depression in Patients With Head and Neck Cancer

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an double-blinded, randomized controlled clinical trial to determine if Venlafaxine can prevent development of depression in patients undergoing treatment for head and neck cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged 18 years or older

4. Ability to speak and understand English

5. Have a recently diagnosed cutaneous or mucosal malignancy

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

7. Ability to take medication orally (by mouth or via parenteral route)

8. Willing to adhere to the study drug's dosing protocol

Exclusion Criteria:

1. Age less than 18 years

2. Inability to speak or understand English

3. Primary malignancy of thyroid or parathyroid origin

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

5. Currently receiving medication as treatment for depression or anxiety

6. Known allergic reaction to components of study drug

7. Have uncontrolled pain or chronic pain disorder

8. Treatment with another investigational drug or other intervention within 30 days

9. Females of child-bearing age who are pregnant or nursing