Venlafaxine for Depression in Head and Neck Cancer Patients

Overseen By Jessica Grayson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alabama at Birmingham

Must not be taking: Antidepressants, Antianxiety

Disqualifiers: Thyroid cancer, Psychosis, Schizophrenia, MDD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 3 weeks

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jessica Grayson, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

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

Willing to adhere to the study drug's dosing protocol

Provision of signed and dated informed consent form

Exclusion Criteria

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

I have chronic pain that is not well-managed.

I am pregnant or nursing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the treatment group receive venlafaxine with dose titration over 3 weeks, while the control group receives no pharmacological treatment

3 weeks

3 visits (telephone)

Initial Follow-up

Participants follow up 6-8 weeks after beginning their chosen treatment regimen for head and neck cancer, completing study questionnaires and vital sign collection

6-8 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored every three months for up to one year, with vital signs, concomitant medications, adverse events, and questionnaire responses collected

9 months

3 visits (in-person)

Treatment Details

Interventions

• Venlafaxine

Trial Overview 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.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 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 Group Active Control 1 Intervention

No intervention will be provided for this group

Venlafaxine is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Efexor for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder
• Panic disorder

Approved in United States as Effexor for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder
• Panic disorder

Approved in Canada as Effexor for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder
• Panic disorder

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+